Articles about new Crohn's Disease drugs, treatment methods etc.


Contents
*Data From Novogen Inflammatory Bowel Disease Drug Phase I Clinical Trial Shows Promise
*New Crohn's Disease Therapy, Marketing Authorisation Application In Europe For CIMZIATM
*Naltrexone Offers Relief For Crohn's Sufferers
*A Surgery For Crohn's That Saves The Intestine
*Elan And Biogen Idec Submit Supplemental Biologics License Application To The Fda For The Approval Of Tysabri? As A Treatment For Crohn's Disease
*Clinical trial examines impact of artichokes on inflammatory bowel disease
*UCB Provides Update On CIMZIA(TM) For Crohn's Disease And Rheumatoid Arthritis In The US
*Tequila raw ingredient being developed into drug-carrier that targets colon diseases
*Tequila Raw Ingredient Being Developed Into Drug-carrier That Targets Colon Diseases
*PDL BioPharma Announces Long-Term Nuvion(R) Data Presented At 2007 Digestive Disease Week
*Ocera Therapeutics, Inc. Completes Enrollment In FHAST1, A Pivotal Phase 3 Clinical Trial In Fistulizing Crohn's Disease
*Capsule Endoscopy Is Effective In Diagnosing Childhood GI Problems
*New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
*ECP May Be Effective In Treating Crohn's Disease
*In Crohn's Disease CEACAM6 Helps E. Coli Stick To Intestinal Lining
*Large Genome Study Finds Genes Behind Common Diseases
*Remicade(R) Receives EU Approval As First And Only Biologic Treatment For Pediatric Crohn's Disease
*Abbott's HUMIRA? (Adalimumab) Approved In The European Union For The Treatment Of Crohn's Disease
*First-Step Test For Patients With Crohn's Disease Should Be PET/CT
*Protein C Signaling Impacts Inflammatory Bowel Disease
*Gene Recipe For Common Disease
*Abbott Launches Humira (Adalimumab) For Crohn's Disease
*Remicade? Receives EU Approval As First And Only Biologic Treatment For Paediatric Crohn's Disease
*Kids With Crohn's Disease Find Comfort, Leading-edge Treatment At Pediatric Infusion Center
*Heart Drugs May Help People With Bowel Disorders
*First-time Link Between Food Intolerance And Illness
*Gene Identified For Crohn's Disease In Children
*Pivotal CIMZIA? Data In Crohn's Disease Published In New England Journal Of Medicine
*Certolizumab Pego Found To Be Effective New Therapy For Patients With Crohn's Disease
*Elan And Biogen Idec Preparing To Appeal Ruling On European Application For Natalizumab For The Treatment Of Crohn's Disease
*Joint FDA Advisory Committee Recommends Approval Of TYSABRI? For The Treatment Of Moderate To Severe Crohn's Disease
*E. coli Bacteria Linked To Crohn's Disease
*Having A Pet Pig May Offer Some Benefits
*Pharmaceutical Benefits Scheme Change For Crohn's Disease
*Understanding The Role Of The Ancestor Of Crohn's Disease Pathogen
*Ocera Therapeutics, Inc. Completes Enrollment In FHAST1, A Pivotal Phase 3 Clinical Trial In Fistulizing Crohn's Disease
*Asacol? 800mg Mr Tablets Approved For Ulcerative Colitis (UC), Maintenance Of Remission Of UC And Crohn's Ileo-Colitis
*Elan And Biogen Idec Announce That FDA Will Extend Regulatory Review Period For TYSABRI? For Crohn's Disease
*Endoscopy Via Capsule Is Turning Up Undiagnosed Cases Of Crohn's Disease
*Elan And Biogen Idec Announce That Fda Will Extend Regulatory Review Period For Tysabri? For Crohn's Disease
*Cytokine Announces Oral Efficacy Of Anti Cytokine Semapimod
*New CIMZIA(R) Data Demonstrates Efficacy For Up To 18 Months In Patients With Crohn's Disease, With No Dose Escalation
*Bowel Surgery Should Not Be Last Resort, UK Study
*Can-Fite: CF101 May Be Effective For The Treatment Of Crohn's Disease
*UCB To Appeal European Negative Opinion On CIMZIA(R) For The Treatment Of Patients With Crohn's Disease
*CHMP Adopts Negative Opinion On Appeal On European Application For Natalizumab For The Treatment Of Crohn's Disease


 
Data From Novogen Inflammatory Bowel Disease Drug Phase I Clinical Trial Shows Promise

03 Mar 2006

A recently completed Phase 1 clinical trial of an investigational drug to treat inflammatory bowel disease has demonstrated rapid absorption indicating potential for development as an oral therapy.

The drug, NV-52, is an anti-inflammatory compound developed by Australian pharmaceutical company, Novogen Limited (Nasdaq: NVGN) (Australia: NRT). The Phase I study was conducted at the Gold Coast Hospital under the direction of clinical pharmacologist, Professor Laurie Howes, Professor of Pharmacology and Therapeutics at Griffith University and a Professor of Medicine at Bond University.

NV-52 is a synthetic analogue based on the phenolic structure of naturally-occurring isoflavones, well known for their range of health benefits when consumed in certain foods and is undergoing development as an orally- delivered non-toxic agent for the maintenance of remission in inflammatory bowel disease.

NV-52 was given orally to 6 healthy young male volunteers as a single dose. Plasma and urine samples were taken immediately prior to drug administration and up to 48 hours following drug administration. After the initial appearance of the drug in plasma, levels rose rapidly in all subjects indicating rapid absorption. The drug appeared to have reasonably consistent bioavailability in all 6 subjects.

Maximum plasma concentrations occurred approximately 4 hours after drug administration and the plasma half life (time at which half of the drug was eliminated) was approximately 8 hours.

Importantly, there were no adverse events reported during the study. Professor Howes said the results indicated that NV-52 given as an oral dose was rapidly absorbed and produced appreciable plasma levels in all volunteers.

"These results indicate that oral therapy with the drug is feasible," Professor Howes said.

The completion of this study in human volunteers is the first step in the clinical development of the drug, demonstrating its safety and the mechanics of accumulation and elimination in humans.

Inflammatory bowel disease, which includes ulcerative colitis and Crohn's Disease, affects around 1 in 1,000 individuals causing pain, diarrhoea, rectal bleeding, weight loss and fatigue and may progress to bowel perforation. Moreover it is believed that such conditions may predispose affected individuals to Colon Cancer.

The cause of these diseases is poorly understood and no current management strategy is effective.

Current treatments do not provide a cure, and all produce significant unwanted side effects.

The disease usually recurs, with relapse rates of up to 80 per cent within the first year post-remission.

On this basis, the most effective management strategy is to devise improved maintenance therapy and treatment regimens which prolong the periods of remission without unwanted side effects.

Previous animal studies indicated NV-52 appears to be suited as a maintenance therapy to prevent relapse of disease.

Novogen is an Australian biopharmaceutical company specialising in the development of therapeutics based on the isoflavonoid chemical structure. The Company is developing a range of therapeutics across the fields of oncology, cardiovascular disease and inflammatory diseases and phenoxodiol, its lead anti-cancer agent is currently in advanced Phase II clinical trialing with its US listed subsidiary Marshall Edwards Inc. (Nasdaq: MSHL). More information on the Novogen Group can be found at http://www.novogen.com and www.marshalledwardsinc.com www.marshalledwardsinc.com.

Under U.S. law, an investigational drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management's current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third arty patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.

Novogen Limited
www.novogen.com www.novogen.com
www.marshalledwardsinc.com www.marshalledwardsinc.com

http://www.medilexicon.com/medicalnews.php?newsid=38758

New Crohn's Disease Therapy, Marketing Authorisation Application In Europe For CIMZIATM

02 May 2006

UCB today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA) for the approval of Cimziatm (certolizumab pegol, CDP870) in the treatment of patients with Crohn's disease. When approved, CIMZIA(TM) will represent the first and only biologic administered by monthly subcutaneous injection as a treatment for Crohn's disease patients.

The European submission follows the filing of a Biologics License Application (BLA) for CIMZIA(TM) to the United States Food and Drug Administration (FDA) on March 1, 2006.

"As a leading European biopharmaceutical company, today's submission to the EMEA is an important milestone for UCB, and underscores our commitment to providing a highly effective therapy for patients living with the burden of Crohn's disease," said Olav Hellebo, President of Inflammation Operations for UCB. "With the European MAA filing following closely behind our recent BLA filing to the FDA, the CIMZIA(TM) development programme is firmly on course. We also continue to explore other indications in the inflammation area for this promising biologic."

The European submission is based on safety and efficacy data from over 1,500 patients with Crohn's disease. The two pivotal phase III studies (PRECiSE 1 and PRECiSE 2) that support the MAA submission met their primary endpoints with statistical significance, demonstrating CIMZIA(TM)'s sustained and consistent efficacy in patients with Crohn's disease. The CIMZIA(TM) MAA submission represents the largest biologic clinical trial database submitted to the EMEA for Crohn's disease treatment. The PRECiSE studies also represent the broadest clinical trial programme, in terms of patient type, in Crohn's disease, encompassing patients with previous exposure to an anti-TNF treatment with a range of concomitant therapies and variable duration of disease.

"The results we have seen in the PRECiSE studies have been highly encouraging, suggesting CIMZIA(TM) to be well-tolerated and effective in the treatment and maintenance of response and remission in patients with Crohn's disease," commented Professor Stefan Schreiber, Professor of Medicine and Gastroenterology at the Christian-Albrechts University, Kiel, Germany, and a leading investigator in the CIMZIA(TM) clinical trials program. "In addition, CIMZIA(TM) when approved will offer the convenience of monthly dosing, combined with a patient-friendly subcutaneous route of administration."

"With Crohn's disease affecting almost half a million people in Europe, the unmet needs of these patients are significant," said Prof. Paul Rutgeerts, Professor of Medicine at the Katholieke Universiteit Leuven, Belgium. "There is a definite need for new therapies, allowing physicians more options for providing effective long-term relief from the significant burden of this debilitating disease."

In addition to the current development programme in Crohn's disease, ongoing studies are investigating the efficacy and tolerability of CIMZIA(TM) in the treatment of rheumatoid arthritis and psoriasis.
http://www.medilexicon.com/medicalnews.php?newsid=42543

Naltrexone Offers Relief For Crohn's Sufferers

29 May 2006

A Penn State College of Medicine pilot study suggests that a drug used to ease symptoms of alcohol and drug addiction may also bring relief to people with Crohn's disease, a chronic inflammatory disorder of the intestine that affects an estimated 500,000 Americans.

In the study, patients with diagnosed Crohn's disease were treated with a low dose of naltrexone, an FDA-approved drug used to ease symptoms of withdrawal from substance abuse, and monitored for improvement of symptoms for 12 weeks. Quality of life surveys were given every four weeks for 16 weeks.

Jill P. Smith, a gastroenterology specialist and researcher at the College of Medicine and Penn State Milton S. Hershey Medical Center, presented her findings recently in Los Angeles at the National Association of Gastroenterologists annual Digestive Diseases Week conference.

The results showed that 89 percent of participants showed an improvement with therapy, while 67 percent achieved remission of symptoms. The only side effect to treatment was sleep disturbance in some patients.

Typical treatment for Crohn's involves using steroids or corticosteroids, which suppress the immune system and can have other toxic side effects. Treatment is often time-intensive and expensive, as well.

"This is a novel approach to treating a common disease, and it's simple, it's safe, and it costs far less than current standards of treatment," Smith said. "We don't yet know the exact mechanisms involved in how it works, but we're working on that as well."

Smith initiated the study using a Dean's Feasibility Grant -- a program designed to encourage investigators to design trials in their area of expertise and seek outside funding. The National Institutes of Health (NIH) recently awarded the College of Medicine $500,000 for the team to continue the study.

In a related study, Smith and other College of Medicine researchers are studying the chemical and molecular mechanisms involved in suppression of inflammatory responses in the intestine when animals are treated with naltrexone. Smith's second team is awaiting a decision on an NIH grant application for that study.

Team members on the first study include Heather Stock, Sandra Bingaman and David Mauger, Department of Health Evaluation Sciences, and Ian Zagon, Department of Neural and Behavioral Sciences, Penn State College of Medicine.

Members of the second study team include Gail L. Matters, and John F. Harms, Department of Biochemistry and Molecular Biology; Leo Fitzpatrick, Department of Surgery; and Anuj Parikh and Nicholas Nilo, Department of Medicine, Penn State College of Medicine.

http://www.medilexicon.com/medicalnews.php?newsid=44162

A Surgery For Crohn's That Saves The Intestine

Article Date: 04 May 2006

Surgeon Dr. Fabrizio Michelassi's "side-to-side isoperistaltic stricturoplasty" procedure can alleviate the pain of Crohn's Disease while sparing the intestine and safeguarding patients from developing malnutrition. The procedure is a welcome alternative to traditional methods which rely on removing part of the intestine and repeating the procedure each time the disease spreads.

For those unfamiliar with Crohn's, the disease attacks and inflames the intestine, making it difficult for food to pass. Patients must often restrict their diet to soft or even liquid meals yet still endure bouts of abdominal pain and nausea.

With the "side-to-side isoperistaltic stricturoplasty," Dr. Michelassi makes a small incision in the patient's stomach and draws out the diseased part of the intestine - coiling it on the patient's stomach like a garden hose, or, from another perspective, drawing the lengths "side to side." From here, he cuts the two lengths of intestine horizontally and, in a long and intricate process, sews the edges together to make a wider length of intestine from the two narrower ones. "Food can now pass and not an inch of intestine is lost," says Dr. Michelassi.

What causes Crohn's is largely unknown and there is no cure. The disease is most common in North America and Europe, but seldom seen in Africa, and its prevalence in Asia and South America is increasing.

Most researchers believe that a certain genetic disposition plus an environmental "trigger" cause Crohn's to surface. Supporting this theory is evidence that immigrants to the western world begin to develop Crohn's at the rate of the native population.

Dr. Michelassi is chairman and Lewis Atterbury Stimson Professor of Surgery at Weill Cornell Medical College and surgeon-in-chief at New York-Presbyterian Hospital/Weill Cornell Medical Center.

http://www.medicalnewstoday.com/medicalnews.php?newsid=42723&nfid=30587

Elan And Biogen Idec Submit Supplemental Biologics License Application To The Fda For The Approval Of Tysabri? As A Treatment For Crohn's Disease

02 Jan 2007

Dublin, Ireland and Cambridge, MA - December 15, 2006 - Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Tysabri? (natalizumab) in the U.S. as a treatment for patients with moderately to severely active Crohn's disease (CD).

The filing is based on the results of three randomized, double-blind, placebo-controlled, multi-center trials of TYSABRI assessing the safety and efficacy as both an induction and maintenance therapy - ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission), ENACT-1 (Efficacy of Natalizumab as Active Crohn's Therapy) and ENACT-2 (Evaluation of Natalizumab As Continuous Therapy). The filing also includes proposed labeling and a risk management plan, both of which are similar to those approved for the multiple sclerosis indication.
http://www.medilexicon.com/medicalnews.php?newsid=59906

Clinical trial examines impact of artichokes on inflammatory bowel disease

Patients at four London hospitals are taking part in a clinical trial to examine how supplements derived from fructose ? found naturally in artichokes, asparagus, leeks, onions, and bananas ? could help patients with inflammatory bowel disease by increasing levels of anti-inflammatory ?good bacteria?.

The two-year clinical trial ? co-ordinated by Barts and The London NHS Trust, Guys and St Thomas? NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, St Mark?s Hospital at North West London Hospitals NHS Trust and King?s College London ? involves 120 patients with Crohn?s disease whose symptoms are being monitored while they receive either prebiotics or a placebo.

Last year, the same researchers established that these prebiotics reduced symptoms in a small number of patients with the condition, but this is the first time a detailed study has been carried out.

Crohn?s disease and ulcerative colitis are both forms of inflammatory bowel disease, affecting one in every 400 people in the UK. They are chronic conditions resulting in significant symptoms such as diarrhoea, rectal bleeding, abdominal pain and weight loss. If left untreated, they result in a marked impairment in a patient?s quality of life. They predominantly occur in teenagers and young adults, and are becoming more common.

UCB Provides Update On CIMZIA(TM) For Crohn's Disease And Rheumatoid Arthritis In The US

27 Mar 2007

UCB has decided to initiate an additional short-term clinical study of CIMZIATM (certolizumab pegol) to confirm the induction of clinical response in moderate to severe active Crohn's disease. UCB will work closely with the Food and Drug Administration (FDA) to finalise the design of the clinical study in order to provide additional clinical efficacy data. Furthermore, by the end of April 2007 UCB will also reply fully to the Complete Response Letter received on December 21, 2006. In its Complete Response Letter, the FDA raised no major issues or concerns around the safety of CIMZIATM or relating to Chemistry, Manufacturing and Controls (CMC) but did question the adequacy of one study design. UCB expects the results from this additional clinical study with CIMZIATM in Crohn's disease in the second half of 2008.

The initial CIMZIATM development programme for the treatment of Crohn's disease met all primary endpoints with statistical significance. Therefore, whether this additional study, which was not part of the pivotal trials program initially agreed with the FDA, will be a pre-approval requirement or a post-approval commitment, is still the subject of the ongoing communications with the FDA.

UCB plans to file a Biologics License Application (BLA) with the FDA for CIMZIATM in the treatment of rheumatoid arthritis by year end 2007.

"We have complete confidence in CIMZIA(TM)'s robust efficacy and competitive safety", commented Roch Doliveux, Chief Executive Officer, UCB, "CIMZIATM will be, at launch, the first anti-TNF which is a PEGylated and Fc-free antibody fragment. We are looking forward to making this new treatment option available to patients who suffer from rheumatoid arthritis and Crohn's disease, and will continue our dialogue with the FDA in order to obtain approval for CIMZIATM in the US as soon as possible".

For CIMZIATM in the treatment of Crohn's disease, UCB also applied for a marketing authorisation by the EMEA in April 2006 and anticipates launch in Europe at the end of 2007. In June 2005, UCB announced significant positive results for the two pivotal phase III trials (PRECiSE 1 and 2) of CIMZIATM in the induction and maintenance of clinical response in moderate to severe active Crohn's disease. The primary endpoints in both the PRECiSE 1 and PRECiSE 2 trials were met with statistical significance.

CIMZIA(TM) in the treatment of rheumatoid arthritis showed positive Phase III results demonstrating significant improvement in signs and symptoms and significant reduction in joint damage supported by strong radiographic data. Both phase III studies, RAPID 1 (027) and RAPID 2 (050), met their primary and co-primary endpoints with statistical significance.

The phase II trial (040) of CIMZIA(TM) in psoriasis has demonstrated strong efficacy in this twelve-week study in the treatment of moderate to severe chronic plaque psoriasis. A retreatment study (044) is ongoing with results expected in the third quarter of 2007.

Tequila raw ingredient being developed into drug-carrier that targets colon diseases

CHICAGO, March 27

Compounds derived from the blue agave, a fruit used to make tequila, shows promise in early laboratory studies as a natural, more effective way to deliver drugs to the colon than conventional drug-carriers, according to chemists at the University of Guadalajara in Mexico. The development could lead to improved treatments for ulcerative colitis, irritable bowel syndrome, cancer, Crohn?s disease and other colon diseases, they say.

Drug delivery to the colon is an ongoing challenge to physicians. Many drugs are destroyed by stomach acids before they?ve had a chance to reach the intestine, where they usually are absorbed. Researchers have tried to circumvent this problem by inserting the drugs into carrier molecules that resist breakdown in the stomach but have had difficulty finding a suitable carrier compound.

The tequila compounds, a class of polysaccharides known as fructans, were developed by the scientists in Mexico into tiny microspheres that are capable of carrying existing drugs that are used to treat colon diseases. Because the compounds resist destruction in the stomach, they could allow more of the drugs to reach the colon intact and improve their effectiveness, the researchers say. Their study was presented today at the 233rd national meeting of the American Chemical Society.

?This study shows that the agave fruit is good for more than just tequila. It also has medicinal value,? says study leader Guillermo Toriz, Ph.D., an assistant professor at the university. ?Agave fructan is the ideal natural carrier of drugs for the colon.?

Researchers have known for some time that fructans, which are polymers of fructose, are resistant to acid degradation and theorized that they might be a useful drug delivery vehicle. But only a few plant sources, such as agave, contain fructans in large amounts. The agave fruit is 80 percent fructans by weight when ripe, the researchers say.

Toriz and his associates extracted fructans from the blue agave, the base ingredient of tequila. They chemically modified the fructan compound to allow drugs to be encapsulated, making the drugs resistant to degradation in the digestive system.

The researchers then prepared microspheres of the compounds and filled them with ibuprofen as a model of drug delivery to the colon. In laboratory tests, the ibuprofen-filled microspheres were exposed to hydrochloric acid for an hour and appeared physically intact upon subsequent microscopic examination, the scientists say.

Topiz and his research group currently are working on improving the durability of the fructans and plan animal studies in the future. If further studies show promise, human studies of the agave microspheres are anticipated. Funding for the study was provided by the Mexican National Science and Technology Council.
http://www.eurekalert.org/pub_releases/2007-03/acs-tri031207.php

Tequila Raw Ingredient Being Developed Into Drug-carrier That Targets Colon Diseases

31 Mar 2007

Compounds derived from the blue agave, a fruit used to make tequila, shows promise in early laboratory studies as a natural, more effective way to deliver drugs to the colon than conventional drug-carriers, according to chemists at the University of Guadalajara in Mexico. The development could lead to improved treatments for ulcerative colitis, irritable bowel syndrome, cancer, Crohn's disease and other colon diseases, they say.

Drug delivery to the colon is an ongoing challenge to physicians. Many drugs are destroyed by stomach acids before they've had a chance to reach the intestine, where they usually are absorbed. Researchers have tried to circumvent this problem by inserting the drugs into carrier molecules that resist breakdown in the stomach but have had difficulty finding a suitable carrier compound.

The tequila compounds, a class of polysaccharides known as fructans, were developed by the scientists in Mexico into tiny microspheres that are capable of carrying existing drugs that are used to treat colon diseases. Because the compounds resist destruction in the stomach, they could allow more of the drugs to reach the colon intact and improve their effectiveness, the researchers say. Their study was presented today at the 233rd national meeting of the American Chemical Society.

"This study shows that the agave fruit is good for more than just tequila. It also has medicinal value," says study leader Guillermo Toriz, Ph.D., an assistant professor at the university. "Agave fructan is the ideal natural carrier of drugs for the colon."

Researchers have known for some time that fructans, which are polymers of fructose, are resistant to acid degradation and theorized that they might be a useful drug delivery vehicle. But only a few plant sources, such as agave, contain fructans in large amounts. The agave fruit is 80 percent fructans by weight when ripe, the researchers say.

Toriz and his associates extracted fructans from the blue agave, the base ingredient of tequila. They chemically modified the fructan compound to allow drugs to be encapsulated, making the drugs resistant to degradation in the digestive system.

The researchers then prepared microspheres of the compounds and filled them with ibuprofen as a model of drug delivery to the colon. In laboratory tests, the ibuprofen-filled microspheres were exposed to hydrochloric acid for an hour and appeared physically intact upon subsequent microscopic examination, the scientists say.

Topiz and his research group currently are working on improving the durability of the fructans and plan animal studies in the future. If further studies show promise, human studies of the agave microspheres are anticipated. Funding for the study was provided by the Mexican National Science and Technology Council.
http://www.medilexicon.com/medicalnews.php?newsid=66392

PDL BioPharma Announces Long-Term Nuvion(R) Data Presented At 2007 Digestive Disease Week

23 May 2007

Data presented at the Digestive Disease Week (DDW) meeting this week in Washington D.C. by Dr. William Sandborn from the Mayo Clinic suggest that Nuvion (visilizumab), an antibody in development as a treatment for intravenous steroid-refractory ulcerative colitis (IVSR-UC), administered on day 1 and day 2, produced a sustained clinical response up to 310 days and was adequately tolerated. The results presented were from long-term follow up of 138 patients who had received Nuvion in a Phase 1 and Phase 1/2 study as a treatment for IVSR-UC, which contributes to the majority of an estimated 30,000 colectomy procedures performed in the U.S. each year. In addition, early data also will be presented at the meeting regarding the Nuvion antibody's potential as a treatment for Crohn's disease.
http://www.medilexicon.com/medicalnews.php?newsid=71791

Ocera Therapeutics, Inc. Completes Enrollment In FHAST1, A Pivotal Phase 3 Clinical Trial In Fistulizing Crohn's Disease

Article Date: 09 Oct 2007 - 0:00 PDT
Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced today that it has completed the patient enrollment of its Phase 3 study in fistulizing Crohn's disease. This pivotal, double-blind, placebo controlled study, FHAST1 (Fistula Healing with AST-120), has been designed to determine the efficacy and safety of oral AST-120 in 240 patients with Crohn's disease suffering from perianal fistulas. Initial data from the trial will be available in the first quarter of 2008.

"We are very pleased to have completed the enrollment in our FHAST1 pivotal trial evaluating AST-120 in a timely manner," stated Laurent Fischer, M.D., President and CEO of Ocera Therapeutics. "We would like to thank our investigators and patients in North America, Europe and Israel for their participation in the study."

Data from a double blind, placebo controlled Japanese study of AST-120 in fistulizing Crohn's disease sponsored by Kureha and presented at the Digestive Disease Week in May 2006 demonstrated that AST-120 significantly reduces draining fistulas compared to placebo.

"Up to one third of patients with Crohn's disease suffer from draining perianal fistulas, a chronic and debilitating condition that significantly affects their quality of life," said Professor Stephen Hanauer, M.D., Director of the Section of Gastroenterology and Nutrition at the University of Chicago and the Principal Investigator in the study. "Despite effective treatments, there is an unmet need for new and well-tolerated oral agents for patients with mild to moderate Crohn's disease who suffer from fistulas."

"We were pleased to participate in this Phase 3 trial evaluating the efficacy and safety of AST-120, a new oral treatment option, in fistulizing Crohn's disease," added Professor Simon Travis, M.D., Clinical Director of Gastroenterology and Endoscopy at John Radcliffe Hospital, Oxford and the lead investigator in Europe.

Ocera also recently announced the initiation of Phase 2 trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy. AST-120 is an oral agent known to adsorb bile acids, toxins and mediators of inflammation from the gastrointestinal tract with the potential to address multiple gastrointestinal diseases. Ocera in-licensed AST-120 from Kureha Corporation based in Tokyo, Japan. AST-120 is not absorbed in the gut and is marketed in Japan and Korea for chronic kidney disease, where it has been used in more than 200,000 patients.

About FHAST1

Fistula Healing With AST-120 is a double-blind, placebo controlled pivotal Phase 3 trial evaluating the efficacy and safety of AST-120 for eight weeks in 240 patients. The primary efficacy endpoint of the study is the number of patients with at least a 50 percent reduction in the number of draining fistulas at both week four and week eight compared to the baseline. Secondary endpoints include changes in Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI), two markers of disease severity and quality of life. Ocera expects initial data to be released in the first quarter of 2008. Patients treated in the FHAST1 study who respond to therapy are followed up for six months. In addition, patients who did not respond to the initial regimen have the opportunity to switch to the alternate treatment, ensuring that patients randomized to placebo who fail therapy can have access to AST-120.

For information on Ocera Therapeutics sponsored clinical trials, please visit http://www.clinicaltrials.gov. Key word: AST-120.
http://www.medicalnewstoday.com/articles/84919.php?nfid=30587

Capsule Endoscopy Is Effective In Diagnosing Childhood GI Problems

Article Date: 24 May 2007 - 0:00 PDT

Researchers at Jefferson Medical College have shown that capsule endoscopy is effective in diagnosing gastrointestinal bleeding and small bowel Crohn's disease in children. The technology has been used successfully at Thomas Jefferson University Hospital for more than five years to diagnose unexplained abdominal bleeding in adults.

"By using the device, which is not much bigger than a vitamin pill and can be swallowed with a glass of water, the diagnosis can eliminate what used to require an IV, sedation and a long scope in children," says Anthony Infantolino, M.D., clinical director of Endoscopic Ultrasound and Photodynamic Therapy and co-director of the Gastrointestinal Bleeding Center at Thomas Jefferson University Hospital.

Lead researcher Vaibhav Mehendiratta, M.D., will present the results at Digestive Disease Week 2007 in Washington, D.C., on Monday, May 21, at 8 a.m., (Abstract M1403).

The study looked at the success of the device and conclude that it is effective and successful in three areas:

In expediting the diagnosis and treatment of small bowel disease.

In detecting the presence, activity and severity of small bowel Crohn's disease.

Of improving diagnosis while limiting radiation exposure to children with Crohn's disease.

In conducting the research, 34 patients, whose ages range from 7 to 19 years, underwent capsule endoscopy procedure. The subjects qualified because they were experiencing unexplained abdominal pain, GI bleeding, diarrhea, anemia and weight loss.

All were able to swallow the capsule easily. Abnormal findings were seen in 25 (74 percent) of the patients. Four patients who were originally diagnosed as not having Crohn's disease using conventional radiographic and endoscopic studies, had diagnostic findings consistent with Crohn's disease on capsule endoscopy.

Members of the team who conducted this study at Thomas Jefferson University Hospital in Philadelphia, Pa., are: Vaibhav Mehendiratta, M.D.,

-- Michael DiMarino', M.D., Anthony Infantolino, M.D., Sidney Cohen, M.D.,

-- Mitchell Conn, M.D., David Kastenberg, M.D., Leo Katz, M.D.,

-- Ilene Fardella, M.A., Lenore Miranda, M.A., Tracy Henwood, M.A.

Thomas Jefferson University
211 S. 9th St., Ste 310
Philadelphia, PA 19107-5506
United States
http://www.jefferson.edu/main
http://www.medicalnewstoday.com/articles/71922.php

New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's

Article Date: 24 May 2007 - 12:00 PDT

Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA? (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalised due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).

Crohn's disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn's disease, so maintenance of remission from disease flares is one of the primary goals of treatment.

People with Crohn's disease may be hospitalised for a variety of reasons, from fever and vomiting to intestinal obstruction and infections, sometimes leading to surgery. Previous studies have shown that hospitalisation is responsible for approximately 60 percent of the direct cost of Crohn's disease and that the average cost per hospital stay is estimated (based on published cost data from 1997) to be about $37,000 per patient in 2006 dollars. Hospitalisation is also associated with a negative impact on health-related quality of life in patients with Crohn's disease.

Data from the Phase III, pivotal study, called CHARM, were evaluated to assess the effect of ongoing treatment with HUMIRA on the risk of hospitalisation. At one year, this analysis showed that patients taking placebo (13.9 percent) were more than twice as likely as patients on HUMIRA (5.9 percent; p<0.01) to be hospitalised from Crohn's disease.

"Patients on HUMIRA throughout the one-year analysis were significantly less likely to be hospitalised because of their Crohn's disease. Maintaining treatment with HUMIRA was the only independent factor in this analysis that helped patients reduce the risk of Crohn's related hospitalisation," said Brian G. Feagan, M.D., lead investigator of the analysis, Department of Medicine, Epidemiology and Biostatistics, University of Western Ontario, London Health Sciences Centre, London, ON, Canada.
http://www.medicalnewstoday.com/articles/71875.php

ECP May Be Effective In Treating Crohn's Disease

Article Date: 30 May 2007 - 1:00 PDT

Results from an international multi-center Phase II clinical trial suggest that extracorporeal photopheresis (ECP) may be effective in treating patients with clinically active (OR symptomatic) Crohn's disease who cannot tolerate or are refractory to immunosuppressants and/or anti-TNF agents. A 50% response rate after 3 months of ECP treatment was noted in the study, using standard disease activity criteria, as presented this afternoon at a scientific research session of Digestive Disease Week (DDW). The majority of patients who responded to ECP therapy had a notable improvement in their disease symptoms and signs after only six weeks of treatment.

"We show in this pilot study that ECP is effective in patients with Crohn's disease (CD) that have previously failed the strongest therapies we currently have," explains Maria Abreu, MD, Associate Professor in The Henry D. Janowitz Division of Gastroenterology and in the Center for Immunobiology at The Mount Sinai Medical Center. ECP is believed to bolster tolerance in the immune system, which may be important in immune-mediated diseases such as Crohn's. In contrast, most patients with inflammatory bowel disease are currently treated with medicines that suppress the immune system. Unlike ECP, those medications can have many serious side effects.

The 28 patient trial studied the safety and efficacy of ECP in patients with a Crohn's Disease Activity Index (CDAI) of at least 220 and less than 450 indicating that at least moderately active symptomatic CD was present. Clinical response was defined as a CDAI decrease of 100 or greater from baseline and/or a CDAI of less than 150 at week 12. Patients received two treatments of ECP weekly from weeks 0-4 and two treatments every other week from weeks 6-12 with no infectious complications reported.

"The findings of our study suggest that Crohn's disease patients who have not responded to other therapies may benefit from ECP," concludes Dr. Abreu.
http://www.medicalnewstoday.com/articles/72328.php

In Crohn's Disease CEACAM6 Helps E. Coli Stick To Intestinal Lining

Article Date: 30 May 2007 - 13:00 PDT

In Crohn's disease, the lining of the small intestine is abnormally colonized by E. coli organisms that are able to adhere to and invade intestinal epithelial cells. In a study appearing online in advance of publication in the June print issue of the Journal of Clinical Investigation, Arlette Darfeuille-Michaud and colleagues from Universite d'Auvergne, France, show that the adherent-invasive E. coli (AIEC) adhere to a region of intestinal epithelial cells known as the brush border in patients with Crohn's disease, but not in healthy individuals. They show that this adhesion is dependent on the expression of the receptor CEACAM6 (carcinoembryonic antigen-related cell adhesion molecule 6) on the surface of the epithelial cells. They go on to show that CEACAM6 expression is increased in Crohn's disease patients after infection with AIEC bacteria, indicating that this organism can promote its own colonization in individuals with Crohn's disease. The authors conclude that CEACAM6 expression in individuals with inflammatory bowel disease could be used as a diagnostic marker for Crohn's disease.
http://www.medicalnewstoday.com/articles/72101.php

Large Genome Study Finds Genes Behind Common Diseases

Article Date: 07 Jun 2007 - 0:00 PDT

In the largest ever study published to date, a consortium of UK scientists has discovered over 20 genes and regions of the human genome that contribute to diseases such as diabetes, rheumatoid arthritis and coronary heart disease.

The Wellcome Trust Control Consortium's 9 million pound study is a collaboration of 200 UK scientists from 50 teams at dozens of UK institutions. Between them they have analysed nearly 10 billion pieces of genetic information from 17,000 people throughout the UK in two years.

Their work comprises the largest ever study on the genetic origins of disease and is published this week in the journals Nature and Nature Genetics.

The human genome is made up of a long sequence of more than 3 million base pairs of four DNA building blocks with the chemical names adenine (A), thymine (T), guanine (G) and cytosine (C). Every now and again there occurs a disruption to the order of a group of the building blocks, a mutation, and these are called single nucleotide polymorphisms (SNPs, pronounced "snips" for short).

People who share the same ethnic lineage often share the same SNPs. For instance, most Europeans share about 8 million of them. In this study, the scientists examined half a million SNPs and found more than 10 genes plus fragments of DNA that appear to be linked to elevated risk of some common diseases.

Chair of the Consortium, Professor Peter Donnelly from the University of Oxford said that:

"Many of the most common diseases are very complex, part 'nature' and 'nurture', with genes interacting with our environment and lifestyles."

"By identifying the genes underlying these conditions, our study should enable scientists to understand better how disease occurs, which people are most at risk and, in time, to produce more effective, more personalised treatments," he added.

Many of the discoveries were a surprise; scientists had not thought them to be related to disease. As more large scale studies complete their work, it is likely that more such surprises could be waiting to be discovered.

Dr Mark Walport, Director of the Wellcome Trust explained:

"This research shows that it is possible to analyse human variation in health and disease on an enormous scale. It shows the importance of studies such as the UK Biobank, which is seeking half a million volunteers aged between 40 and 69, with the aim of understanding the links between health, the environment and genetic variation."

Of particular significance is the discovery of a link between the autoimmune diseases type 1 diabetes and Crohn's disease which causes inflammatory bowel. A gene called PTPN2 appears to link the two conditions.

Also, in the case of Crohn's, the study has confirmed the importance of the role of autophagy in the development of the disease. Autophagy (literally self- eating) is a cellular process for clearing cells of rubbish like unwanted bacteria. In Crohn's disease the immune system reacts to normal gut bacteria, and more understanding of autophagy and how it deals with bacteria could have clinical significance.

Professor John Todd from the University of Cambridge, who led this part of the study said:

"The link between type 1 diabetes and Crohn's disease is one of the most exciting findings to come out of the Consortium."

"It is a promising avenue for us to understand how the two diseases occur. The pathways that lead to Crohn's disease are increasingly well understood and we hope that progress in treating Crohn's disease may give us clues on how to treat type 1 diabetes in the future," he added.

The Consortium scientists analysed DNA samples from 2,000 patients for each of seven major diseases (bipolar disorder, Crohn's disease, coronary heart disease, hypertension, rheumatoid arthritis and type 1 and type 2 diabetes) and 3,000 healthy controls. The next stage will be to get samples from larger populations to confirm the results.

Professor Donnelly summed up the contribution this study has made:

"Human genetics has a chequered history of irreproducible results, but this landmark collaboration of scientists in Britain has shown conclusively that the new approach of analysing a large subset of genetic variants in large samples of patients and healthy individuals works."

"We are now able to effectively scan most of the common variation in the human genome to look for variants associated with diseases. This approach will undoubtedly herald major advances in how we understand and tackle disease in the future," he concluded.

However, the researchers are cautious when it comes to suggesting how soon genetic screening could be used to help individuals find out if whether they are going to develop a disease.

Having a predisposition is no longer seen as a matter of a particular gene. It could be a complex pattern of several genes acting together, and a tipping point that is decided by environment and lifestyle factors. However, the knowledge of whether they have one or both genes that predisposes an illness could help people make informed decisions about lifestyle and reduce the risk of that condition being triggered.

The Consortium is also looking into the genes behind tuberculosis (TB), breast cancer, autoimmune thyroid disease, multiple sclerosis and ankylosing spondylitis and will be publishing their findings later this year.

UK Biobank is a registered charity and major UK medical research project that aims to improve the prevention, diagnosis and treatment of a wide range of serious and life-threatening illnesses. These illnesses include cancer, heart diseases, diabetes, arthritis and forms of dementia.

The project is currently recruiting 500,000 people aged 40 to 69 from across the UK to be assessed and give blood samples.

The UK Biobank is funded by the Wellcome Trust, the Medical Research Council, the Department of Health, the Scottish Executive and the Northwest Regional Development Agency. It is also backed by the National Health Service and many of the UK's major medical research charities, including the British Heart Foundation and Cancer Research UK.
http://www.medicalnewstoday.com/articles/73393.php

Remicade(R) Receives EU Approval As First And Only Biologic Treatment For Pediatric Crohn's Disease

Article Date: 08 Jun 2007 - 0:00 PDT

Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP) today announced that the European Commission has approved a new indication for REMICADE(R) (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. REMICADE has been studied only in combination with conventional immunosuppressive therapy. This approval follows a positive opinion granted in March by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA).

"Crohn's disease significantly impacts the quality of life of children suffering from this condition," said Salvatore Cucchiara, M.D., Department of Pediatrics, Gastrointestinal Motility and Endoscopy Unit, University of Naples. "Infliximab provides physicians with a new treatment option that addresses the unique aspects of this difficult-to-treat disease in the pediatric population."

REMICADE is the first and only biologic therapy approved in the EU for the treatment of pediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain, weight loss and in some patients, delayed development and stunted growth.

"This approval recognizes the unique value of REMICADE as it is the first and only biologic therapy available to children suffering with Crohn's disease in Europe, who previously had limited therapy options," said Robert J. Spiegel, M.D., chief medical officer, Schering-Plough Research Institute.

In May 2006, the United States Food and Drug Administration (FDA) approved REMICADE for pediatric patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE was first approved in the U.S. for adult Crohn's disease in 1998 and later for adult ulcerative colitis in 2005.

The safety and efficacy of REMICADE across all indications have been well established in clinical trials over the past 14 years and through commercial experience with nearly 925,000 patients treated worldwide across all indications.

The label extension will permit physicians to administer a 5 mg/kg intravenous infusion of REMICADE over a 2-hour period followed by additional 5 mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter. Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further REMICADE treatment in pediatric patients not responding within the first 10 weeks of treatment.

Clinical Trial Information: REACH

The approval was based on data from the Phase III REACH (a Randomized, Multicenter, Open-label Study to Evaluate the Safety and Efficacy of Anti-TNF Monoclonal Antibody REMICADE in Pediatric Subjects with Moderate to Severe Crohn's Disease) trial. In the REACH trial, 112 patients (6 to 17 years of age; all required to be receiving 6-MP, AZA or MTX; 35% receiving corticosteroids) with moderate to severe, active Crohn's disease (median PCDAI of 40) and an inadequate response to conventional therapies received 5 mg/kg infliximab at weeks 0, 2, and 6. Patients assessed by the investigator to be in clinical response at week 10 were randomized and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen. Patients who lost clinical response during maintenance treatment could receive infliximab at a higher frequency or dose.

The proportion of subjects in clinical response at week 10 was 88.4% (99/112). The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/112). At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/52) than the q12 week maintenance treatment group (35.3%, 18/51; p=0.013). At week 54, the proportion of subjects in clinical remission was 55.8% (29/52) and 23.5% (12/51) in the q8 week and q12 week maintenance groups, respectively (p<0.001).

Thirty-two evaluable pediatric patients (9 in the q8 week and 23 in the q12 week maintenance group) lost response and then received infliximab at a higher dose or more frequently. Twenty-four of these thirty-two patients (75.0%) regained clinical response.

Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at weeks 10, 30 and 54, respectively, in the combined q8 week and q12 weeks maintenance group.

In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed.

The following adverse events were reported more commonly in pediatric Crohn's disease patients in the REACH trial than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bone fracture (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%). Other special considerations are discussed below.

About Pediatric Crohn's Disease

Crohn's disease is a chronic illness that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss.

Children with Crohn's disease may also experience delayed development and stunted growth. Although it can involve any area of the gastrointestinal tract from the mouth to the anus, it most commonly affects the small intestine and/or colon.
http://www.medicalnewstoday.com/articles/73537.php

Abbott's HUMIRA? (Adalimumab) Approved In The European Union For The Treatment Of Crohn's Disease

Article Date: 08 Jun 2007 - 1:00 PDT

Abbott announced today that it has received marketing authorization from the European Commission for the use of HUMIRA? (adalimumab) as a treatment for severe Crohn's disease. HUMIRA is the first self-administered biologic for the treatment of Crohn's disease and offers an effective and convenient treatment option that can help enable patients to maintain control of their disease. This announcement follows FDA approval for the Crohn's disease indication, which Abbott received in February, and is the fourth approved indication for HUMIRA in the United States and the European Union.

Crohn's disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than 1 million people in North America and Europe. It affects people of all ages, but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn's disease and few treatment options exist for patients suffering with this chronic condition.

"Crohn's can have a devastating impact on patients, many of whom are young and active, making it difficult to carry out normal day-to-day activities," said Rod Mitchell, chairman, European Federation of Crohn's & Ulcerative Colitis Associations. "The unpredictable nature of the disease can seriously impact their quality of life and self-esteem. For the half million people across Europe suffering from Crohn's, this approval offers hope to help them regain control of their disease."

Common symptoms of Crohn's disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding. Complications include intestinal obstruction, fistulas (ulcers that form tunnels to surrounding tissues), and malnutrition. Over the course of their disease, as many as 75 percent of patients with Crohn's disease will undergo surgery at least once for complications or disease resistant to treatment. Of those who undergo surgery to remove a portion of the intestines (resection), half will experience a relapse within five years.

"After I was diagnosed with Crohn's, the unpredictable symptoms made working and relationships difficult. I was afraid to leave the house," said Rocio Lopez, a HUMIRA clinical trial patient. "With HUMIRA, my Crohn's symptoms are under control and I have more freedom to live my life."

"The approval of HUMIRA in Crohn's disease means that an underserved patient population now has a clinically effective treatment option that they can administer themselves," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development at Abbott. "For the thousands of people across Europe with Crohn's disease, HUMIRA represents a new, effective, and convenient treatment option."

HUMIRA for Crohn's Disease

The approval was based on data from three pivotal trials of HUMIRA in more than 1,400 adult patients with moderately to severely active Crohn's disease. The CLASSIC I, CHARM and GAIN trials supporting the indication for Crohn's disease evaluated the efficacy and safety of HUMIRA in a diverse group of moderate to severe adult Crohn's disease patients, from those who were naive to anti-tumor necrosis factor alpha (TNF-alpha) therapy, to patients who had previously lost response or were unable to tolerate infliximab, an anti-TNF agent for treatment of Crohn's disease.

In each trial, clinical remission was measured by a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general well being and other measures.

Key outcomes include:

? The CLASSIC I induction trial evaluated HUMIRA for the induction of clinical remission Of 299 anti-TNF naive patients, 36 and 24 percent of patients receiving HUMIRA (160 mg at week zero followed by 80 mg at week two and 80 mg at week zero followed by 40 mg at week two, respectively) achieved clinical remission at week four compared to 12 percent treated with placebo (p<0.001 for 160 mg/80 mg dose group and p=0.06 for 80mg/40mg dose group).

? The CHARM trial studied HUMIRA for the maintenance of clinical remission. CHARM was a 56-week trial that enrolled 854 patients with moderate to severe Crohn's disease. After a four-week open label induction phase during which all subjects received 80 mg HUMIRA at week zero followed by 40 mg HUMIRA at week two, 58 percent of patients (n=499) demonstrated clinical response to HUMIRA (a CDAI decrease equal to or greater than 70 from baseline). These patients were randomized to receive either HUMIRA 40 mg every other week (eow), HUMIRA 40 mg weekly, or placebo. Of those who continued on HUMIRA 40 mg every other week (n=172), 40 percent were in clinical remission at week 26 (p<0.001) and 36 percent were in remission at week 56 (p<0.001), versus 17 percent and 12 percent of patients in the placebo group, respectively. For those who continued taking HUMIRA 40 mg weekly, 47 percent were in clinical remission at week 26 and 41 percent were in remission at week 56 (p<0.001).

? In GAIN, a four-week induction trial of 325 patients who lost response or were intolerant to infliximab, three times as many patients taking HUMIRA achieved clinical remission at week four versus placebo (21 percent versus 7 percent, p≤ 0.001).

The safety profile of HUMIRA in the Crohn's clinical trials was similar to that seen in HUMIRA clinical trials for rheumatoid arthritis (RA). Adverse events reported by >5 percent of HUMIRA treated patients with a greater incidence than patients taking placebo include injection site irritation, injection site pain, injection site reaction, nausea, joint pain, inflammation of the nose and pharynx, abdominal pain, headache and fatigue.

In the EU, the recommended HUMIRA induction dose for adult patients with severe Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2. If there is a need for a more rapid response to therapy, patients can take 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) following by 80 mg at week 2, with the awareness that the risk for adverse events is higher during induction.

Important Safety Information

Globally, prescribing information varies; refer to the individual country product label for complete information. For U.S. safety information, visit www.HUMIRA.com.

Serious infections, sepsis, rare cases of tuberculosis (TB), and opportunistic infections, including fatalities, have been reported with the use of TNF antagonists, including HUMIRA. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their RA could predispose them to infections. Patients must be monitored closely for infections, including tuberculosis, before, during and after treatment with HUMIRA. Treatment should not be initiated in patients with active infections until infections are controlled. HUMIRA should not be used by patients with active TB or other severe infections such as sepsis and opportunistic infections. Patients who develop new infections while using HUMIRA should be monitored closely. HUMIRA should be discontinued if a patient develops a new serious infection until infections are controlled. Physicians should exercise caution when considering use of HUMIRA in patients with a history of recurring infection or with underlying conditions that may predispose patients to infections.

TNF-blocking agents have been associated with reactivation of hepatitis B (HBV) in patients who are chronic carriers of the virus. Some cases have been fatal. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating HUMIRA.

The combination of HUMIRA and anakinra is not recommended.

TNF antagonists, including HUMIRA, have been associated in rare cases with demyelinating disease and serious allergic reactions. Rare reports of pancytopenia including aplastic anemia have been reported with TNF-blocking agents. Adverse events of the haematologic system, including medically significant cytopenia have been infrequently reported with HUMIRA.

More cases of malignancies including lymphoma have been observed among patients receiving a TNF antagonist compared with control patients in clinical trials. The size of the control group and limited duration of the controlled portions of studies precludes the ability to draw firm conclusions. Furthermore, there is an increased background lymphoma risk in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation. During the long-term open-label trials with HUMIRA, the overall rate of malignancies was similar to what would be expected for an age, gender and race matched general population. With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF antagonist cannot be excluded.

In clinical studies with another TNF antagonist, a higher rate of serious congestive heart failure (CHF) related adverse events including worsening CHF and new onset CHF have been reported. Cases of worsening CHF have also been reported in patients receiving HUMIRA. Physicians should exercise caution when using HUMIRA in patients who have heart failure and monitor them carefully. HUMIRA should not be used in patients with moderate or severe heart failure.

The most frequently reported adverse event (>1/10 patients) at least possibly causally related to HUMIRA is injection site reaction (including pain, swelling, redness or pruritus). Other common adverse events (reported by >1/100 patients) at least possibly causally related to HUMIRA include lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infection (including urinary tract infections), upper respiratory infection, lymphopenia, dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias), infection, irritation or inflammation of the eye, cough, nasopharyngeal pain, diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea, hepatic enzymes increased, rash, dermatitis and eczema, pruritus, hair loss, musculoskeletal pain, pyrexia, fatigue (including asthenia and malaise)
http://www.medicalnewstoday.com/articles/73480.php

First-Step Test For Patients With Crohn's Disease Should Be PET/CT

Article Date: 08 Jun 2007 - 18:00 PDT

The molecular imaging power of PET/CT is invaluable in noninvasively monitoring Crohn's disease - a chronic inflammatory disease of the gastrointestinal tract that mainly affects young people, according to a study released by Belgian scientists at the 54th Annual Meeting of SNM, the world's largest society for molecular imaging and nuclear medicine professionals.

"Our study is the first one demonstrating the value of PET/CT in Crohn's disease," said Roland Hustinx, head of the nuclear medicine division at the University Hospital of Li?ge and professor of nuclear medicine at the University of Li?ge. "PET/CT (positron emission tomography/computed tomography) imaging - with the radiotracer fluorodeoxyglucose or FDG - could be used as a first-step test in patients with clinical or biological signs suggesting active disease," he noted. "PET/CT can answer the major question: What is the activity of the disease explained Hustinx. Crohn's disease, an inflammatory bowel disease (IBD) that can affect the digestive system, has no medical cure, and its causes are unknown, explained Hustinx. Once the disease begins, it can fluctuate between periods of inactivity (remission) and activity (relapse). During relapses, symptoms - varying in nature, frequency and intensity - include abdominal pain, diarrhea and worsening general physical condition. Estimates indicate that up to 2 million people in this country could be affected by Crohn's and related diseases. IBD most commonly begins during adolescence and early adulthood. "The clinical course of the disease is characterized by a succession of periods of clinical relapses and remissions," said Hustinx. "Its diagnosis relies on clinical and biological signs (markers of inflammation in the blood) as well as direct examination of the bowel using ileocolonoscopy, an endoscopic examination of the large bowel, where the last part of the small bowel (ileum) is also examined," added Hustinx, who indicated that prevalence of the disease is increasing. "Endoscopic evaluation - a diagnostic medical procedure in which a small, flexible tube with a light and lens is inserted into the body to assess the interior surfaces of an organ - is the gold standard to answer, "What is the activity of this disease?" said Hustinx. The answer to this question will decide whether the clinician prescribes a treatment that is likely to be effective but also very costly and associated with side effects. "Ileocolonoscopy is invasive, unpleasant for the patient, sometimes incomplete due to unreachable segments and can only assess mucosal lesions, while the disease may sometimes affect deeper parts of the bowel wall," he indicated. "The big advantage of PET/CT is that it is noninvasive, simple, fast and without any side effects. There was no preparation for the patients, except that they fasted for six hours. Each study took less than 20 minutes," said Hustinx. "If the PET/CT is positive, the doctor should confirm the results using endoscopy. If the PET/CT is negative, there would be no need for the endoscopy - given the high negative predictive value of the technique," he added. "In our study, all bowel areas that showed severe endoscopic lesions were correctly identified by PET/CT. There was not a single case in which the ileocolonoscopy showed severe lesions and PET/CT showed a normal metabolic activity," said Hustinx. "Conversely, this means that when the PET/CT is negative - no matter how important the clinical symptoms are - the disease is not active," he added. "PET/CT has, therefore, the potential to deeply modify the exploration algorithm of patients with Crohn's, reducing the number of endoscopic examinations and allowing a better, noninvasive monitoring of the disease's activity," he indicated. PET/CT molecular imaging - with radioactive drugs such as FDG - enables the collection of both biological and anatomical information during a single exam, with PET picking up metabolic signals of body cells and tissues and CT offering a detailed map of internal anatomy. "Our results must be confirmed by other investigators on a larger scale," said Hustinx, indicating that his team is currently conducting a study evaluating the capacity of PET/CT to assess early on the response of the disease to "biological treatments." Treatment has been significantly improved over the past few years with the development of biological treatments, which have shown potential for obtaining mucosal healing in Crohn's disease, noted Hustinx. "This mucosal healing has been associated with higher sustained quality of life, lower rate of hospitalization and lower need for surgery. A sustained clinical remission - and a control of intestinal lesion - has become the target of new treatment strategies," he said. http://www.medicalnewstoday.com/articles/73120.php **Protein C Signaling Impacts Inflammatory Bowel Disease** ---- Article Date: 12 Jun 2007 - 20:00 PDT Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, involves both immune and nonimmune cells. Previous studies have established that the vasculature of the gut mucosa is an important nonimmune component of intestinal inflammation and that the protein C (PC) signaling pathway is an important checkpoint in the inflammatory process. Endothelial protein C receptor (EPCR) and thrombomodulin (TM) are expressed at high levels in the resting microvasculature and they convert PC into its active, anti-inflammatory form. In a study appearing online in advance of publication in the July print issue of the Journal of Clinical Investigation, Silvia Danese and colleagues from Istituto di Ricovero e Cura a Carattere Scientifico in Rozzano, Italy, show that in Crohn's disease and ulcerative colitis there is a loss of EPCR and TM expression by endothelial cells that line the intestine, which results in impaired PC activation by the inflamed mucosal microvasculature. The authors went on to show that administration of recombinant, activated PC to human intestinal endothelial cells had a potent anti-inflammatory effect and reversed experimental colitis. The results of the study suggest that that PC pathway is crucially involved in regulating intestinal inflammation triggered by changes in the mucosal microvasculature. Restoring the PC pathway may therefore represent a potential therapeutic approach to suppressing intestinal inflammation in inflammatory bowel disease. http://www.medicalnewstoday.com/articles/73617.php **Gene Recipe For Common Disease** ---- Article Date: 13 Jun 2007 - 1:00 PDT Scientists have isolated at least 25 genes that cause seven of the most common hereditary diseases including diabetes and arthritis in the world's largest genetic study. The genes are responsible for heart disease, hypertension, type 1 and type 2 diabetes, Crohn's disease, bipolar disorder and rheumatoid arthritis, according to results published today in the international science journal Nature. Another 58 genes with possible links to the same family diseases have also been uncovered by British and Australian scientists working on the $16.6 million (?7 million) study funded by the Wellcome Trust Case Control Consortium (WTCC). UQ Professor Matthew Brown , one of the principal investigators, said the genetic signposts would allow researchers to pinpoint who was at most risk from the diseases and would also help produce better treatments. "Using genetic markers is far more accurate than just using family history," Professor Brown, from UQ's Diamantina Institute for Cancer, Immunology and Metabolic Medicine, said "The family history doesn't tell you which individual genes are involved so it doesn't tell you anything about the mechanism by which these diseases occur." Professor Brown said the study analysed 540,000 varying DNA sequences from each of the 19,000 Brits who took part in the study. The study was 10 times bigger than previous population genetics studies which had linked less than a dozen genes to the seven hereditary diseases. He said there were several population groups in Australia which could be used for similar studies but they needed large scale funding which was not available. "So far, Australia hasn't done any of these studies because the NHMRC [National Health and Medical Research Council] doesn't have a mechanism for funding them." More study results will be released in August on the genetic makeup of breast cancer, multiple sclerosis, autoimmune thyroid disease and ankylosing spondylitis. Professor Brown leads the Musculoskeletal Genetics Group at UQ's Diamantina Institute and is an expert in rheumatoid arthritis and ankylosing spondylitis, which is a type of inflammatory arthritis which stiffens joints and can damage the eyes and heart. All genetic data from the study will be available to researchers. "That's a really important precedent because it makes it a huge resource for anyone researching these diseases, not just geneticists, but people who are researching any basic mechanism of these diseases." UQ alumni and university medallist Professor Peter Donnelly, now a Professor of Statistical Genetics at Oxford University, leads the study project. The Wellcome Trust is a charity that was created in 1936 with a ?13 billion endowment and is now the United Kingdom's largest non-governmental source of funds for biomedical research. The University of Queensland, Brisbane Australia http://www.uq.edu.au http://www.medicalnewstoday.com/articles/73909.php **Abbott Launches Humira (Adalimumab) For Crohn's Disease** ---- Article Date: 14 Jun 2007 - 1:00 PDT Abbott launches HUMIRA? (adalimumab) as a treatment for severe, active Crohn's disease. Adalimumab is the first fully-human tumour necrosis factor antagonist (anti-TNF) to receive a licence for Crohn's disease, a chronic inflammatory disease of the gastrointestinal tract that impairs the lives of up to 60,000 people in the UK1 and causes 70-80% of patients to require major surgery within their lifetime.2 "Currently, there is no cure for Crohn's disease, which reinforces the need for effective treatment options that will help maintain control of the disease. Adalimumab represents an important advance in managing this serious and debilitating condition," said Professor Ghosh, Gastroenterologist from Hammersmith Hospital, London. Clinical trials of adalimumab showed that: -- Adalimumab demonstrated response from as early as week one3 -- Three times as many patients who continued on adalimumab maintained clinical remission*at one year compared with placebo4 -- 29% of patients on adalimumab in clinical remission at one year were able to discontinue use of corticosteroids compared with only 6% on placebo.4 Adalimumab is the second anti-TNF licenced for Crohn's disease but the first to offer adult patients the convenience of self-injection at home. "The unpredictability of Crohn's disease makes it difficult to lead a normal life as the disease can flare-up at any time. We welcome the approval of adalimumab as a new treatment option which will assist patient independence and improve quality of life for Crohn's disease patients" said Richard Driscoll, Director of the National Association for Colitis and Crohn's Disease (NACC). How adalimumab works Adalimumab is a fully human monoclonal antibody that works by specifically blocking the activity of TNF, which is a key component of the inflammatory process associated with Crohn's disease. Fully human monoclonal antibodies are essentially indistinguishable from antibodies found in the body and represent the latest advance in the evolution of monoclonal antibodies. Clinical trials The EMEA's decision is based on the results of three-randomised, double-blind, placebo-controlled, multi-centre trials of adalimumab. In each trial, clinical remission was measured by a Crohn's Disease Activity Index (CDAI) score of less than 150. CDAI is a weighted composite score of eight clinical factors that evaluate patient wellness, including daily number of liquid or very soft stools, severity of abdominal pain, levels of general wellness and other measures. CLASSIC I (Clinical assessment of Adalimumab Safety and efficacy Studied as an Induction therapy in Crohn's disease)3 was a study of 299 patients with moderate to severe Crohn's disease who were new to anti-TNF therapy. Results showed that adalimumab demonstrated response from week 1 and resulted in a greater percentage of patients achieving clinical remission at four weeks compared to placebo. CHARM (Crohn′s trial of the fully Human antibody Adalimumab for Remission Maintenance) 4 was a 56-week trial that enrolled 854 patients with moderate to severely active Crohn's disease. The 499 patients who demonstrated clinical response (CDAI decrease of greater than or equal to 70 points from baseline) to adalimumab during a four-week, open-label induction phase were randomized to receive either adalimumab or placebo. Three times as many patients who continued on adalimumab maintained clinical remission at one year compared to placebo. GAIN (Gauging Adalimumab effectiveness in Infliximab Non-Responders)5 evaluated the efficacy of adalimumab in 325 patients with moderate to severely active Crohn's disease who had previously lost response or were unable to tolerate infliximab. Adalimumab induced significantly higher rates of clinical remission compared to placebo. http://www.medicalnewstoday.com/articles/74070.php **Remicade? Receives EU Approval As First And Only Biologic Treatment For Paediatric Crohn's Disease** ---- Article Date: 14 Jun 2007 - 1:00 PDT The European Commission (EC) has approved a new indication for Remicade? (infliximab) allowing for the treatment of severe, active Crohn's disease (CD) in paediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy, or who are intolerant to, or have contraindications for, such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy. This approval follows a positive opinion granted in March 2007 by the Committee for Medicinal Products for Human Use (CHMP) for the European Medicines Agency (EMEA). 'Infliximab is one of the most significant therapeutic advances in therapy for Crohn's disease in the last decade. Now children with moderate to severe Crohn's disease have access to a treatment previously reserved only for adults. Used appropriately, infliximab can transform the quality of life of children and adolescents struggling with the chronic and disabling symptoms of severe Crohn's disease,' said Dr Robert Heuschkel, Clinical Lead and Consultant Paediatric Gastroenterologist, Centre for Paediatric Gastroenterology, Royal Free Hospital, London. Infliximab is the first and only biologic therapy approved in the EU for the treatment of paediatric CD, a debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhoea, fever, abdominal pain, weight loss and, in some patients, delayed development and stunted growth. http://www.medicalnewstoday.com/articles/74053.php **Kids With Crohn's Disease Find Comfort, Leading-edge Treatment At Pediatric Infusion Center** ---- Article Date: 06 Jul 2007 - 0:00 PDT Seventeen-year-old Eliot Drieband explains what it's like to have Crohn's disease a type of inflammatory bowel disease in the same matter-of-fact way she describes preparing for an advanced placement exam, working on the school newspaper, starting an organ donor awareness club for teens and being a peer counselor for other kids facing chronic, life-altering illnesses. "The disease is part of my life, just like my hair color, but it's not 'me'," she says, acknowledging that it's easier dealing with it now than when she and her family learned the diagnosis five years ago. "It's nothing to be afraid of. I've chosen not to hide it; it's awkward but it doesn't limit my abilities," said the Pacific Palisades, CA, high school senior. According to Drieband's physician, Marla C. Dubinsky, M.D., medical director of the Pediatric Inflammatory Bowel Disease Center at Cedars-Sinai Medical Center, young people who have inflammatory bowel disease have so much to cope with, but learn not to let the disease derail their lives. She says about her patients, "They're amazing." Dubinsky, a pediatric gastroenterologist, and her colleagues at Cedars-Sinai currently treat more than 400 children from 2 to 21 years of age with inflammatory bowel disease (IBD). Crohn's disease and ulcerative colitis are two different types of inflammatory bowel diseases that affect the digestive system. Symptoms include diarrhea, sometimes severe enough to require frequent trips to the bathroom (up to 20 or more times a day); significant abdominal pain, bloody stool, blocked bowels, fever, extreme weight loss and anemia. Treatment includes drug therapy, education, nutritional and psychosocial counseling, and surgery. Both forms of IBD are complex and can be difficult to diagnose. According to the Crohn's and Colitis Foundation of America, IBD can strike at any age but occurs most often in young people between the ages of 15 and 35. Since IBD tends to run in families, scientists know genes play a role in its etiology, but have not determined the exact cause of the disease. Some people have long periods of remission, but there is no cure. Once every 10 weeks, Drieband receives a biologic therapy called infliximab (trade name Remicade? at the pediatric infusion center at Cedars-Sinai. Infliximab, Dubinsky explained, is used for patients who have not responded adequately to standard therapies such as anti-inflammatory drugs, corticosteroids, immune system suppressors and antibiotics. Biologic agents selectively target key inflammatory processes involved in the development of a disease - in this case infliximab blocks the body's inflammation response. Its side-effects can include upper respiratory infections and other potentially serious reactions. The Al and Heidi Azus Foundation's Pediatric Infusion Center opened in early April within the Cedars-Sinai Children's Health Center. The colorful two-room suite is furnished with X-Boxes, flat screen televisions, DVD players and comfortable reclining chairs all designed to lessen the emotional stress young patients sometimes experience during the two to three hours required to administer intravenous treatments. The center is one of only a few pediatric IBD centers in the North America that conducts research activities and provides education and treatment all at one campus. Dubinsky explained that Cedars-Sinai wants to ensure that patients referred to the center have access to the most advanced technologies and therapies as soon as they are shown to be safe and effective, and yet it is also careful and conservative in medical treatment for young patients who have IBD. "We choose patients to receive these families of biological therapies very carefully. The risk/benefit ratio of these very powerful medications clearly needs to favor a successful therapeutic outcome," said Dubinsky. Drieband adds that, "the new center is wonderful. It's really cozy and more private than the adult infusion center where I used to go. I can watch a movie ? but I usually fall asleep." The first in Southern California and one of only 10 hospitals in the state whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 19 consecutive years, it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available at http://www.cedars-sinai.edu. Cedars-Sinai Medical Center 8700 Beverly Blvd., Rm 2429A Los Angeles, CA 90048 United States http://www.cedars-sinai.edu http://www.medicalnewstoday.com/articles/76087.php **Heart Drugs May Help People With Bowel Disorders** ---- Article Date: 07 Jul 2007 - 1:00 PDT Statin drugs which are widely prescribed to prevent heart disease may emerge as a future treatment for Crohn's disease, an inflammatory bowel condition, a scientist said last Tuesday. Surgical research fellow Dr. John Burke was addressing the Association of Coloproctology meeting in Glagow about research which is reinforcing the idea that statins are becoming 'the aspirin of the 21st Century'. Just as aspirin has been found to be effective in the treatment of many different conditions, from heart disease and strokes to rheumatic disease, so have statins. As well as reducing cholesterol and preventing arteries from clogging up, statins have been found to lower blood pressure and reduce the risk of strokes. Research also suggests that statins may help to soothe the pain of rheumatoid arthritis, and prevent dementia and donor tissue rejection in kidney transplant patients. Dr Burke, of the Conway Institute, University College Dublin, said his research on Crohn's disease was carried out after statins had been shown to help people with fibrotic disease in other organs. Fibrosis occurs when the body's natural healing processes is disturbed, creating excessive scar tissue. It is a key component of diseases affecting millions of people worldwide. These include diabetes, congestive heart failure, respiratory and kidney failure and age-related mascular degeneration, one of the leading causes of blindness. "People with diabetes can develop fibrotic disease in their kidneys, but if they're taking statins, their condition tend to improve," said Dr. Burke. "We reasoned the same may be true in the gut in the treatment of Crohn's disease. "We isolated cells from the gut and found that statins prevent them from becoming activated and fibrotic. We showed that statins do this by preventing growth factors present in the gut in Crohn's disease from changing the gene expression of these cells. This resulted in the prevention of stricture formation, a process leading to obstruction of the gut which is the most common reason why someone with Crohn's disease will require surgery. At present there are no effective treatments to prevent it occurring". He stressed that this exciting research was only the first step. The next one will involve further laboratory work to replicate the results of this preliminary research. The Association of Coloproctology of Great Britain and Ireland at The Royal College of Surgeons of England 35-43 Lincoln's Inn Fields London WC2A 3PE http://www.medicalnewstoday.com/articles/76157.php **First-time Link Between Food Intolerance And Illness** ---- Article Date: 12 Jul 2007 - 0:00 PDT Researchers from University College London have found compelling evidence for the first time to link food intolerances and serious illness. A six-month programme has shown potential links with foodstuffs and Crohn's Disease, and ulcerative colitis. The discovery could prompt an entire rethink in the medical profession across a range of conditions, from irritable bowel syndrome to migraine. To date, patient reports of intolerances have largely been seen as 'in the mind', and discounted. At UCL, researchers worked with three specific groups of patients one with Crohn's Disease (28 patients), a second with ulcerative colitis (25), and a control group with a benign coincidental thyroid lump (24). Each was asked in advance which of 113 foods they felt gave them a bad reaction, and specifically whether that reaction was a gut reaction or non-gut one. Then, over the six months, each had their blood tested for individual intolerances of the 113 foodstuffs through Yorktest Laboratories, measuring levels of IgG antibodies. In the control group, most people were found to have few intolerances; in the disease groups there was a much higher frequency. Specific findings included: -- Those with Crohn's Disease and ulcerative colitis were typically found to be intolerant to three or more foodstuffs. -- Ulcerative colitis subjects most commonly reported sensitivity to peanut (29 per cent of UC subjects versus 13 per cent of control), cashew (25 per cent versus 13 per cent), lentils and broccoli (19/4), hazelnut and brazil nuts (19/13), chilli (19/8). These subjects most commonly reported sensitivity to chilli (44/8), wheat (40/8), milk (36/8), kidney and haricot beans (both 24/0), coffee and onions (20/4) and oranges (20/0). Dr. Anton Emmanuel from UCL said: "The results were compelling. If there had been no link, one would have expected the results to be 50/50 - i.e. random chance association between (i) patients with objective measure of food sensitivity and (ii) subjective report of food sensitivity. "For years, GPs - indeed most of the medical community - have perceived food intolerances as being largely in the mind, and this is probably the first research project to demonstrate that they could well be wrong. Indeed this points to what could be a direct link between food intolerance and patient symptoms." The researchers are planning further experiments to investigate whether IgG antibodies can predict foods that provoke disease on a double blind placebo controlled food challenge - and conversely, whether specific food avoidances based on antibody results might be worthwhile. MURRAY PR 26-27 West Street Horsham West Sussex http://www.murraypr.com http://www.medicalnewstoday.com/articles/76578.php **Gene Identified For Crohn's Disease In Children** ---- Article Date: 19 Jul 2007 - 0:00 PDT Pediatrics researchers have identified a gene variant that raises a child's risk of Crohn's disease, a chronic and painful condition attributed to inflammation of the gastrointestinal tract. The research reinforces previous results by German researchers, who found the same gene variant associated with the adult form of Crohn's disease. Researchers from The Children's Hospital of Philadelphia and The University of Pennsylvania reported their results in a letter in the August issue of the journal Gut. "Because Crohn's disease is complex, with multiple genes interacting with each other and with environmental factors, it's important to sort out specific genes and to replicate previous findings," said the study's first author, Robert N. Baldassano, M.D., director of the Center for Pediatric Inflammatory Bowel Disease at Children's Hospital. "There are different types of Crohn's disease, so classifying types by genetic profiles may help us select the most appropriate treatments for each patient." The study compared the genomes of 143 children with Crohn's disease to genomes of 282 matched control subjects. The study team found that 64 percent of children with Crohn's disease had a specific variant form of the gene ATG16L1, compared with 52 percent of the healthy children. The odds ratio for children with the gene variant was 1.62 compared to control children, meaning that those who have the variant were 62 percent more likely to have Crohn's disease than children with the more common allele. A separate test that analyzed trios (a Crohn's patient and both parents) also found an association between the ATG16L1 gene variant and disease symptoms. This finding strengthened the results of the pediatric case-control study. The genome-wide association study, which used highly automated analytic equipment to scan each patient's DNA for more than half a million genetic markers, was performed at the Center for Applied Genomics at Children's Hospital. The Center's tools spell out a patient's genotype -- the specific pattern of variations among an individual's 30,000 genes. Established in the summer of 2006, the center is taking on one of the largest genotyping projects in the world, and is the largest one dedicated to genetic analysis of childhood diseases. "This study is among the first that our center has published on a gene associated with a complex childhood disease, but we have many projects under way," said senior author Hakon Hakonarson, M.D., Ph.D., the director of the Center for Applied Genomics. "Our goal at the Center is to discover the major disease-causing variants and genes that influence complex pediatric diseases, thus providing a scientific foundation for translating those discoveries into successful treatments." Earlier this month, Hakonarson collaborated with researchers in Montreal to identify a gene associated with insulin-dependent diabetes in children. Other projects at the Center are seeking genes associated with pediatric asthma, allergy, obesity, attention-deficit hyperactivity disorder, autism, hypertension, juvenile rheumatoid arthritis and the pediatric cancer neuroblastoma. The gene implicated in the current research, ATG16L1, plays an important role in the autophagosome pathway, a sequence of biological events involved in processing bacteria within cells. While the mechanisms are not fully understood, said Baldassano, a mutation in the gene may weaken a cell's ability to degrade cellular waste products, including bacteria. When unprocessed waste products pile up within the cell, they may stimulate the inflammatory response that characterizes Crohn's disease. Although much research remains to be done, he added, better understanding of the disease process may guide doctors to new and improved therapies. "If an excess of bacteria is the problem, we may find antibiotics effective in treating this type of Crohn's disease. Other approaches may be to use immune- boosting drugs to blunt the inflammation, or determining whether particular foods interact with genetic susceptibilities to affect disease symptoms. Understanding gene influences gives us a more targeted way to look at disease physiology, and also may suggest targets for treatment." Baldassano and Hakonarson said that they will continue to search for other gene variants associated with Crohn's disease and the closely related bowel disorder ulcerative colitis. Financial support for the study came from the National Institutes of Health, the Edmunds Fund, the Heineman Foundation, the IBD Family Research Council and The Children's Hospital of Philadelphia. About The Children's Hospital of Philadelphia: The Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country, ranking third in National Institutes of Health funding. In addition, its unique family-centered care and public service programs have brought the 430-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.chop.edu. The Children's Hospital of Philadelphia http://www.chop.edu http://www.medicalnewstoday.com/articles/77229.php **Pivotal CIMZIA? Data In Crohn's Disease Published In New England Journal Of Medicine** ---- Article Date: 20 Jul 2007 - 1:00 PDT Two pivotal Phase III clinical trials demonstrating the safety and sustained efficacy of CIMZIA? (certolizumab pegol) in moderate-to-severe Crohn's disease (CD) were published in two articles in the July 19 issue of the New England Journal of Medicine (NEJM). The PRECiSE 1 and PRECiSE 2 studies demonstrate that a statistically significantly greater proportion of moderate-to-severe Crohn's disease patients achieved and sustained clinical response with CIMZIA? compared to placebo. CIMZIA? was administered subcutaneously every four weeks to 26 weeks, with induction doses at weeks 0, 2 and 4. Patients who responded to open-label induction therapy with CIMZIA?, and subsequently remained on treatment, were more likely to have maintained response and remission at 26 weeks than patients who received placebo in the PRECiSE 2 trial. CIMZIA? is an investigational agent for the treatment of Crohn's disease and represents the first and only PEGylated anti-TNF (Tumor Necrosis Factor) alpha antibody. PEGylation of CIMZIA? allows for subcutaneous administration every four weeks without evident need for dose escalation. Unlike currently available treatments, CIMZIA? is Fc-free. The Fc region is associated with potential in vitro cellular cytotoxicity. Lead investigators of the studies were William J. Sandborn, M.D., Professor of Medicine at the Mayo Clinic College of Medicine, Rochester, Minnesota, USA (PRECiSE 1) and Professor Stefan Schreiber, Hospital for General Internal Medicine, University-Hospital Schleswig-Holstein, Christian Albrechts University, Kiel, Germany (PRECiSE 2). "There is an unmet need for an anti-TNF therapy with the convenience of subcutaneous administration every four weeks and stable dosing for patients with moderate-to-severe Crohn's disease. Based on these published results, certolizumab pegol will be a welcome addition to our treatment options," said Professor Schreiber. "Publication of the results from these two large multinational studies by the New England Journal of Medicine allows healthcare professionals to collectively assess the effect of the PEGylated anti-TNF certolizumab pegol in the treatment of patients with Crohn's disease." PRECiSE 1 Study Results [1] In PRECiSE 1, patients were randomized to either CIMZIA? or placebo at study entry without an open-label treatment induction phase. PRECiSE 1 represents a unique trial design in Crohn's disease - no anti-TNF has previously been evaluated in an induction trial extending beyond 12 weeks in patients with active Crohn's disease. In PRECiSE 1, significantly more CIMZIATM patients achieved and maintained clinical response, as defined by a 100 point or greater decrease in the Crohn's Disease Activity Index (CDAI) [2] at Week 6 and Week 26 of the study. Specifically, 35 percent of CIMZIA? patients versus 27 percent of placebo patients achieved response at Week 6 (p= 0.02). The percentages of patients who responded at both weeks 6 and 26 were 23 percent for CIMZIA? versus 16 percent for placebo (p= 0.02). Furthermore, significantly more CIMZIA? patients experienced improved quality of life compared to placebo at Week 26 as demonstrated by increased scores on the Inflammatory Bowel Disease Questionnaire (IBDQ), a validated self-assessment tool used to quantify Crohn's disease symptom severity. [3] PRECiSE 2 Study Results [4] PRECiSE 2 involved an open-label induction phase during which all patients received CIMZIA? at weeks 0, 2 and 4. Responders at Week 6 were then randomized to either CIMZIA? or placebo every four weeks (double-blind) and evaluated through Week 26. Results demonstrated 64 percent of patients achieved clinical response during induction, and a statistically significant number of patients maintained response through Week 26 on CIMZIA? versus placebo irrespective of baseline C-reactive protein (CRP) levels (63 vs. 36 percent, p< 0.001). Additionally, more CIMZIA? patients achieved disease remission (defined as CDAI scores of 150 or less) at Week 26 (48 vs. 29 percent, p< 0.001). Similar to PRECiSE 1, CIMZIA? patients also experienced improved quality of life as assessed by IBDQ. The safety and tolerability profile of CIMZIA? was consistent with that expected of an anti-TNF agent. The most common reported AEs across both studies were headache, nasopharyngitis, cough and abdominal pain. In PRECiSE 1, serious adverse events (SAEs) occurred in 10.3 percent of CIMZIA? patients, and 7.0 percent of placebo patients. Local injection reactions were low (3.0 percent). Serious infections occurred in 2 percent of CIMZIA? patients versus less than 1 percent of placebo patients. Only eight percent of CIMZIA? patients developed detectable anti-certolizumab pegol antibodies. In PRECISE 2, SAEs occurred in 7 percent of CIMZIA? patients during induction, and in 6 percent of CIMZIA? patients versus 7 percent of placebo patients during the double blind phase. Local injection reactions were low (2 percent during induction, and 3 percent during the double-blind phase on CIMZIA? versus 15 percent on placebo). Serious infections occurred in 3 percent of CIMZIA? patients versus less than 1 percent of placebo patients during the double-blind phase. Only 9 percent of patients who entered the initial induction phase developed detectable antibodies against certolizumab pegol at some point during the study. PRECiSE Clinical Trials Program The PRECiSE clinical trials (PEGylated Antibody Fragment Evaluation in Crohn's Disease), sponsored by UCB, form the basis for regulatory submissions to U.S. and European regulatory authorities for CIMZIA?. The globally-conducted PRECiSE program, composed of two placebo-controlled studies and two open-label safety follow-up studies, is one of the largest, most comprehensive development programs for an anti-TNF in Crohn's disease, including more than 1,300 patients. In addition to the PRECiSE 1 and 2 studies, PRECiSE 3 and 4 are long-term, open label trials assessing the longer-term safety and tolerability of CIMZIA? up to five years. Interim PRECiSE 3 data, recently presented at Digestive Disease Week 2007, demonstrated that CIMZIA? maintained long-term response, up to 18 months, at stable doses in those patients responding to CIMZIA? in PRECiSE 2. http://www.medicalnewstoday.com/articles/77336.php **Certolizumab Pego Found To Be Effective New Therapy For Patients With Crohn's Disease** ---- Article Date: 21 Jul 2007 - 11:00 PDT Mayo Clinic researchers have found that Certolizumab pegol is an effective treatment for adults with Crohn's disease, according to two new studies. These findings were published in today's issue of the New England Journal of Medicine. Certolizumab pegol blocks tumor necrosis factor, an important cause of inflammation in Crohn's disease. Crohn's disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn's disease has no known medical cure. Currently approved therapies that also block tumor necrosis factor include intravenous infusions of infliximab or subcutaneous injections of adalimumab. "Many patients with Crohn's disease who receive repeated administration of infliximab or adalimumab will eventually stop responding to the therapy," says William Sandborn, M.D., a study author and gastroenterologist at Mayo Clinic. "Therefore, it is important to have a variety of options in this drug class to help patients avoid Crohn's disease symptoms over longer periods of time." According to Dr. Sandborn, the dosing regimen for certolizumab pegol is more patient-friendly than infliximab or adalimumab, with less frequent subcutaneous injections that can be self-administered. The first study, led by Dr. Sandborn, set out to determine if certolizumab pegol was effective in easing the symptoms of patients with active Crohn's disease. The study involved 662 adult patients with moderate to severe Crohn's disease, and represents a unique trial design in Crohn's disease. This is the first double-blind, placebo-controlled trial in which a drug that blocks tumor necrosis factor has been evaluated beyond 12 weeks in the treatment of Crohn's disease. Researchers found that 35 percent of patients who received certolizumab pegol achieved an improvement in their clinical symptoms after six weeks, while 27 percent of patients who received a placebo experienced improved symptoms in the same period. Likewise, after six months, 37 percent of patients who received certolizumab pegol achieved an improvement in their clinical symptoms, compared to 27 percent of patients who received a placebo. The second study set out to determine if certolizumab pegol was effective as a long-term maintenance therapy for patients with Crohn's disease. It involved 668 patients, of whom 428 (64 percent), responded, or achieved an improvement in their clinical symptoms, after taking certolizumab pegol for six weeks. The response was maintained for six months in 63 percent of patients receiving certolizumab pegol, while 36 percent of patients who received a placebo from week six to six months experienced improved symptoms in that period. Additionally, clinical remission from symptoms was achieved in 48 percent of patients in the certolizumab pegol group, compared to 29 percent of those in the placebo group. Certolizumab pegol is not yet approved by the Food and Drug Administration (FDA). One side effect of certolizumab pegol that was observed during the studies, and is seen in other drugs that block tumor necrosis factor, was a small increase in the risk for serious infection, including one case of pulmonary tuberculosis. However, injection-site reactions were very low and patients experienced low rates of antinuclear antibodies, which can occasionally cause lupus-like symptoms when elevated. "Approximately 25 percent of the patients in these studies had previously been treated with infliximab therapy and had lost response," says Dr. Sandborn. "These studies show that certolizumab pegol could be a new option to treat patients with Crohn's disease, both those who have never been treated before, and those who have lost response to other therapies. Upon FDA approval, the use of certolizumab pegol could significantly improve quality of life for many patients with Crohn's disease." http://www.medicalnewstoday.com/articles/77287.php **Elan And Biogen Idec Preparing To Appeal Ruling On European Application For Natalizumab For The Treatment Of Crohn's Disease** ---- Article Date: 23 Jul 2007 - 0:00 PDT Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008. "Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease." An application for approval of TYSABRI? (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007. http://www.medicalnewstoday.com/articles/77531.php **Joint FDA Advisory Committee Recommends Approval Of TYSABRI? For The Treatment Of Moderate To Severe Crohn's Disease** ---- Article Date: 06 Aug 2007 - 0:00 PDT Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 12 in favor to 3 opposed, with 2 abstaining, to recommend approval of TYSABRI? (natalizumab) as a treatment for moderate-to-severe Crohn's disease in patients who have failed or cannot tolerate available therapies. The recommendation is advisory to the FDA, and the agency is not bound by this recommendation. Elan and Biogen Idec will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available for the treatment of appropriate patients with Crohn's disease. Discussions with the FDA will include adapting the existing TYSABRI risk management plan and addressing any other issues raised during the Committees' deliberations on this new indication. About TYSABRI? (natalizumab) TYSABRI is a treatment approved for relapsing forms of multiple sclerosis (MS) in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001). TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea. TYSABRI is approved in the United States, European Union, Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec. http://www.medicalnewstoday.com/articles/78837.php **E. coli Bacteria Linked To Crohn's Disease** ---- Article Date: 10 Aug 2007 - 15:00 PDT A team of Cornell University scientists from the College of Veterinary Medicine, Weill Cornell Medical College and the College of Agriculture and Life Sciences have discovered that a novel group of E. coli bacteria -- containing genes similar to those described in uropathogenic and avian pathogenic E. coli and enteropathogenic bacteria such as salmonella, cholera, bubonic plague -- is associated with intestinal inflammation in patients with Crohn's disease in their research paper published by The ISME Journal: Multidisciplinary Journal of Microbial Ecology. Crohn's disease, an incurable inflammatory disorder of the intestine -- most commonly found in the lower part of the small intestine called the ileum -- affects 1-in-1,000 people in Europe and North America. Thus far, gut bacteria have long been suspected in playing a pivotal role in the development of Crohn's disease, but the specific bacterial characteristics that drive the inflammatory response have remained elusive. Researchers at Cornell examined possible causes for the disease in patients with Crohn's restricted to the ileum and the colon versus healthy individuals. "Given that only about 20 percent of fecal bacteria can be cultured, our group adopted a broad culture-independent approach to target specific subgroups of bacteria for quantitative in situ analysis and culture based characterization," said Kenneth Simpson, professor of small animal medicine at the College of Veterinary Medicine. "Our findings raise the possibility that a novel group of E. coli contains opportunistic pathogens that may be causally related to chronic intestinal inflammation in susceptible individuals. They suggest that an integrated approach that considers an individual's mucosa-associated flora in addition to disease phenotype and genotype may improve outcome." The study found an increased level of E. coli bacteria in more inflamed areas of the small intestines instead of MAP, a bacterium related to tubercle bacillus that has been more commonly associated with Crohn's. http://www.medicalnewstoday.com/articles/79093.php **Having A Pet Pig May Offer Some Benefits** ---- Article Date: 15 Aug 2007 - 3:00 PDT Contact with farm environments in infancy might decrease the risk of juvenile Crohn's disease and ulcerative colitis. That's according to a study conducted in Germany entitled, "Contact With Farm Animals in Early Life and Juvenile Inflammatory Bowel Disease: A Case-Control Study." Parents of children (ages 6 to 18) from 13 hospitals received a questionnaire regarding consumption of raw milk, contact with farm animals or pets, age of contact, and presence of respiratory allergies. Of those surveyed, 444 had Crohn's disease (CD), 304 had ulcerative colitis (UC), and 1,481 were control subjects. The control group consisted of children who did not have either of those conditions and were in the hospital undergoing a common eye procedure. Results showed that children with CD and UC were more likely to live in urban areas than were the control children, and the odds of regular contact with any farm animal during the first year of life were reduced significantly for children with CD or UC. The study also found that children with CD had an increased risk of respiratory allergies. The authors ascertain the hypothesis that contact with farm animals during infancy helps protect individuals against childhood allergies, might also hold true for protection against irritable bowel syndrome. http://www.medicalnewstoday.com/articles/79675.php **Pharmaceutical Benefits Scheme Change For Crohn's Disease** ---- Article Date: 19 Aug 2007 - 1:00 PDT A change to the Pharmaceutical Benefits Scheme (PBS) from 1 October 2007 will provide subsidised access to adults and children of Remicade? (infliximab) for the treatment of Crohn's disease. Crohn's disease is an inflammatory disorder of the gastrointestinal tract. It can have a profound impact on professional, family and social life. Those with active Crohn's disease experience chronic abdominal pain, diarrhoea and bowel movements containing blood. Symptoms include fever, anorexia, fatigue and joint pain. About 2,000 additional people will commence Remicade? for the treatment of Crohn's disease in the first full year of listing. The extension to the listing of Remicade? is expected to add $53.9 million to PBS and Repatriation Pharmaceutical Benefits Scheme expenditure between 2007-08 and 2010-11. http://www.health.gov.au http://www.medicalnewstoday.com/articles/80013.php **Understanding The Role Of The Ancestor Of Crohn's Disease Pathogen** ---- Article Date: 03 Oct 2007 - 1:00 PDT An Indian team of researchers led by Seyed E. Hasnain of the Institute of Life Sciences (ILS), University of Hyderabad, India has found that a seemingly unknown mycobacterial organism Mycobacterium indicus pranii (MIP) could be the earliest ancestor of the 'generalist' branch of mycobacterial pathogens. The 'generalist' bacteria infect anything from cockroaches to human and are capable of surviving in soil and water as against human adapted 'specialists' such as tubercle and leprosy bacilli. TB, a disease that killed about 1.7 million humans last year alone, is caused by a member of the Mycobacterial family of pathogens. The finding further suggests that the prominent 'generalist' pathogen M. avium which seriously haunts AIDS patients, together with its close associate M. avium paratuberculosis (MAP), the agent of Crohn's disease in humans and Johne's disease in cattle descended from the MIP. It was also found that the MIP and the MAP bacilli initially inhabited water bodies and infected marine organisms predated by fishes finally arriving on soil through bird-droppings. The MIP bacilli, also called as Mycobacterium w (Mw) were first isolated in India by G. P. Talwar at the All India Institute of Medical Sciences, New Delhi, in eighties and it is currently used, after an extensive and perhaps the largest clinical trial in the world, as an immunotherapeutic against leprosy in India. The success with MIP based leprosy vaccine has led to human clinical evaluations of MIP in interventions against HIV-AIDS, psoriasis and bladder cancer in India. MIP, commercially available as 'Immuvac', is currently the focus of advanced multi-centric phase III clinical trials for its antituberculosis efficacy. The comparative genomics study based on complete sequence of the MIP organism published in October 2, 2007 release of the prestigious open access journal PLoS ONE reports observations based on the first ever whole genome sequencing project from India, carried out jointly by the ILS, the Centre for DNA fingerprinting and Diagnostics also at Hyderabad and the University of Delhi. The study provides an important evolutionary basis for the acquisition and optimization of virulence in mycobacteria and determinants of boundaries therein. Similarly these efforts constitute a step forward in understanding the role of non-pathogenic and saprophytic mycobacteria in immunomodulation and in triggering innate immune responses. The study advocates exploitation of genetic similarity between MIP and MAP as a plausible advantage for therapeutic intervention against Crohn's and Johne's diseases. http://www.medicalnewstoday.com/articles/84417.php **Ocera Therapeutics, Inc. Completes Enrollment In FHAST1, A Pivotal Phase 3 Clinical Trial In Fistulizing Crohn's Disease** ---- Article Date: 09 Oct 2007 - 0:00 PDT Ocera Therapeutics, Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat gastrointestinal and liver diseases announced today that it has completed the patient enrollment of its Phase 3 study in fistulizing Crohn's disease. This pivotal, double-blind, placebo controlled study, FHAST1 (Fistula Healing with AST-120), has been designed to determine the efficacy and safety of oral AST-120 in 240 patients with Crohn's disease suffering from perianal fistulas. Initial data from the trial will be available in the first quarter of 2008. "We are very pleased to have completed the enrollment in our FHAST1 pivotal trial evaluating AST-120 in a timely manner," stated Laurent Fischer, M.D., President and CEO of Ocera Therapeutics. "We would like to thank our investigators and patients in North America, Europe and Israel for their participation in the study." Data from a double blind, placebo controlled Japanese study of AST-120 in fistulizing Crohn's disease sponsored by Kureha and presented at the Digestive Disease Week in May 2006 demonstrated that AST-120 significantly reduces draining fistulas compared to placebo. "Up to one third of patients with Crohn's disease suffer from draining perianal fistulas, a chronic and debilitating condition that significantly affects their quality of life," said Professor Stephen Hanauer, M.D., Director of the Section of Gastroenterology and Nutrition at the University of Chicago and the Principal Investigator in the study. "Despite effective treatments, there is an unmet need for new and well-tolerated oral agents for patients with mild to moderate Crohn's disease who suffer from fistulas." "We were pleased to participate in this Phase 3 trial evaluating the efficacy and safety of AST-120, a new oral treatment option, in fistulizing Crohn's disease," added Professor Simon Travis, M.D., Clinical Director of Gastroenterology and Endoscopy at John Radcliffe Hospital, Oxford and the lead investigator in Europe. Ocera also recently announced the initiation of Phase 2 trials with AST-120 in Irritable Bowel Syndrome and Hepatic Encephalopathy. AST-120 is an oral agent known to adsorb bile acids, toxins and mediators of inflammation from the gastrointestinal tract with the potential to address multiple gastrointestinal diseases. Ocera in-licensed AST-120 from Kureha Corporation based in Tokyo, Japan. AST-120 is not absorbed in the gut and is marketed in Japan and Korea for chronic kidney disease, where it has been used in more than 200,000 patients. About FHAST1 Fistula Healing With AST-120 is a double-blind, placebo controlled pivotal Phase 3 trial evaluating the efficacy and safety of AST-120 for eight weeks in 240 patients. The primary efficacy endpoint of the study is the number of patients with at least a 50 percent reduction in the number of draining fistulas at both week four and week eight compared to the baseline. Secondary endpoints include changes in Crohn's Disease Activity Index (CDAI) and Perianal Disease Activity Index (PDAI), two markers of disease severity and quality of life. Ocera expects initial data to be released in the first quarter of 2008. Patients treated in the FHAST1 study who respond to therapy are followed up for six months. In addition, patients who did not respond to the initial regimen have the opportunity to switch to the alternate treatment, ensuring that patients randomized to placebo who fail therapy can have access to AST-120. For information on Ocera Therapeutics sponsored clinical trials, please visit http://www.clinicaltrials.gov. Key word: AST-120. http://www.medicalnewstoday.com/articles/84919.php **Asacol? 800mg Mr Tablets Approved For Ulcerative Colitis (UC), Maintenance Of Remission Of UC And Crohn's Ileo-Colitis** ---- Article Date: 11 Oct 2007 - 8:00 PDT Procter & Gamble Pharmaceuticals (NYSE: P&G) announced today that Asacol? (mesalazine) 800mg Modified Release (MR) tablets have been approved for the treatment of mild to moderate ulcerative colitis (UC) and maintenance of remission of UC and Crohn's ileo-colitis in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA). Asacol 800mg MR tablets have been approved for moderately active UC patients at the new high 4.8 grams per day dose based on the ASCEND (Assessing the Safety and Clinical Efficacy of a New Dose of 5-ASA) I and II clinical trials that demonstrated Asacol 800mg MR tablets given at 4.8g per day resulted in faster symptom relief compared to 2.4g per day in moderately active UC patients.1 Median time to symptom resolution was 9 days for rectal bleeding and 12 days for resolution of abnormal stool frequency for moderately active UC patients receiving Asacol 800mg MR tablets given at 4.8g per day compared to 16 days and 15 days respectively, with those who received mesalazine 400mg tablets dosed at 2.4g per day.1 Importantly, there were no significant differences in the overall serious side effect profile with Asacol 800mg MR tablets dosed at 4.8g per day compared to mesalazine 400mg dosed at 2.4g per day.2 "This is a clinically useful advance for patients with ulcerative colitis," said Simon Travis, DPhil, FRCP, Consultant Physician and Gastroenterologist at the John Radcliffe Hospital in Oxford. "Symptoms of rectal bleeding and diarrhoea resolve faster on higher dose Asacol, without increasing side effects for acute, moderately active UC patients." "Procter & Gamble is delighted to bring this new option to ulcerative colitis patients," said Hans van Zoonen, Vice President Pharmaceuticals and Personal Healthcare, Europe. "We firmly believe that Asacol 800mg MR tablets will bring faster symptom relief to moderately active UC patients. The development of the 800mg tablet is part of our commitment to provide patients with more dosing choice and convenient options. Asacol is a key pillar to our growing GI franchise, one of three strategic focus areas within P&G Pharmaceuticals," he added. Asacol 800mg MR tablets are indicated for the treatment of mild and moderate acute exacerbations of ulcerative colitis, to be administered at 2.4g/day and 4.8g/day, respectively, in divided doses. Asacol 800mg MR tablets, administered up to 2.4g/day, are also indicated for the maintenance of remission of ulcerative colitis and Crohn's ileo-colitis. Procter & Gamble will advise healthcare professionals as soon as the new product is available for prescription to patients. http://www.medicalnewstoday.com/articles/85294.php?nfid=30587 **Elan And Biogen Idec Announce That FDA Will Extend Regulatory Review Period For TYSABRI? For Crohn's Disease** ---- Article Date: 16 Oct 2007 - 8:00 PDT Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) yesterday announced that the U.S. Food and Drug Administration (FDA) informed the companies that the Agency will extend its regulatory review of TYSABRI? (natalizumab) as a treatment for Crohn's disease by up to 3 months. The companies have been informed by the FDA that the Agency requires additional time to review information regarding the proposed TYSABRI risk management plan for Crohn's disease. Under this revised timeline, the companies anticipate action from FDA on or before January 13, 2008. http://www.medicalnewstoday.com/articles/85663.php?nfid=30587 **Endoscopy Via Capsule Is Turning Up Undiagnosed Cases Of Crohn's Disease** ---- Article Date: 16 Oct 2007 - 10:00 PDT A small capsule that takes "snapshots" of the small intestine as it moves through the digestive tract helped doctors spot cases of Crohn's disease that had gone undiagnosed for up to 15 years, according to researchers at Wake Forest University Baptist Medical Center. Reporting this week at the American College of Gastroenterology's meeting in Philadelphia, the researchers said that of 198 video capsule endoscopies that were performed to evaluate unexplained gastrointestinal bleeding, physicians found six cases of Crohn's disease that hadn't been diagnosed previously, despite the patients having colonoscopies and a variety of other imaging tests. The study is the first to evaluate the prevalence of the Crohn's disease (about 3 percent) among patients having capsule endoscopy to evaluate unexplained bleeding. "With capsule endoscopy, we were able to diagnose cases that previously were difficult or impossible to diagnose," said Richard Bloomfeld, M.D., gastroenterologist and senior researcher. "Some of the patients had been having transfusions for years because of anemia from unexplained bleeding." The research was presented by Sakeitha Crowder, M.D., a resident in internal medicine. Capsule endoscopy has become a standard tool to evaluate unexplained bleeding in the stomach and intestines. Patients swallow a small capsule containing a video camera that takes two images per second over eight hours. "It allows us to see 20 feet of small intestine between the stomach and large intestine -- areas that we cannot reach with other tests," said Bloomfeld. "It's easy, painless and requires no sedation." Crohn's disease is a disorder that causes inflammation of the digestive tract. It is generally easy to diagnose with a colonoscopy or through symptoms that include abdominal pain and diarrhea. In some cases, however, the disease affects part of the intestine that cannot be reached with colonoscopy. The mean age of study patients who were diagnosed with Crohn's disease was 35 years. All were being evaluated for iron deficiency anemia requiring blood transfusions. Only two patients had abdominal pain and diarrhea -- the typical symptoms of Crohn's disease. The length of time that patients had anemia until they were successfully diagnosed ranged from 11 months to 15 years. After correct diagnosis, the patients were successfully treated with medications and none required surgery. "This study suggests the importance of using capsule endoscopy to fully evaluate people with unexplained gastrointestinal bleeding," said Bloomfeld. http://www.medicalnewstoday.com/articles/85684.php?nfid=30587 **Elan And Biogen Idec Announce That Fda Will Extend Regulatory Review Period For Tysabri? For Crohn's Disease** ---- Article Date: 21 Oct 2007 - 0:00 PDT Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced that the U.S. Food and Drug Administration (FDA) informed the companies that the Agency will extend its regulatory review of TYSABRI? (natalizumab) as a treatment for Crohn's disease by up to 3 months. The companies have been informed by the FDA that the Agency requires additional time to review information regarding the proposed TYSABRI risk management plan for Crohn's disease. Under this revised timeline, the companies anticipate action from FDA on or before January 13, 2008. About Crohn's Disease Approximately one million people worldwide have Crohn's disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women. The disease usually causes diarrhea and crampy abdominal pain, often associated with fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), and malnutrition. Most patients eventually require surgery, which has both risks and potential short- and long-term complications. Crohn's disease can have a devastating impact on the lifestyle of patients, many of whom are young and active. Currently there is no medical or surgical cure for Crohn's disease. Many patients fail to respond to current therapies, including biological therapies such as agents that inhibit tumor necrosis factor alpha (TNF-alpha). Due to this failure of current therapies in CD, therapies that have novel biological targets are required. http://www.medicalnewstoday.com/articles/86178.php?nfid=30587 **Cytokine Announces Oral Efficacy Of Anti Cytokine Semapimod** ---- Article Date: 30 Oct 2007 - 0:00 PDT Cytokine PharmaSciences, Inc. (CPSI) announced development of an orally active form of semapimod, its synthetic anti cytokine compound. Semapimod is a potential treatment for inflammatory and autoimmune diseases including rheumatoid arthritis, Crohn's and psoriasis. The compound has previously been tested in clinical trials only as an intravenous infusion and the newly developed oral form should significantly enhance its acceptability to patients and physicians. Semapimod is a synthetic guanylhydrazone that inhibits the activity of various kinases, including Raf kinase, a key enzyme in the MAPK/ERK signal transduction pathway. Semapimod's inhibition of Raf-kinase decreases phosphorylation of MEK, thereby also inhibiting phosphorylation of p38 MAP kinase. This halts production of several important inflammatory cytokines, including TNF-alpha, IL-1, and IL-6. Preclinical studies have repeatedly demonstrated semapimod's efficacy in animal models of inflammatory and proliferative diseases, including endotoxic shock and toxicity, pancreatitis, ischemia and stroke, necrotizing enterocolitis, and neointimal formation. Despite early signals of efficacy, the Phase II studies CPSI conducted in Crohn's disease were dose-limited by local reactions (i.e., phlebitis) to the semapimod-HCl formulation. These reactions led to the need to develop a less irritating intravenous (IV) form. In response, CPSI has developed a new salt form of semapimod with a dramatically improved solubility and tolerability profile, which ultimately resulted in the new orally available formulation. Dr. Daan W. Hommes, (University of Leiden; formerly with the Academic Medical Center, Amsterdam, The Netherlands) tested an IV formulation of semapimod in an early Crohn's disease study. He commented: "The early work with semapimod showed the promise of this drug. Continued development would benefit from improved dosing regimens." Dr. Marco Bruno (AMC, Amsterdam, The Netherlands) tested semapimod IV for prevention of ERCP-induced pancreatitis. He stated: "The trial showed a clear trend toward efficacy when semapimod was used prophylactically. The reductions in the pancreatitis rate and amylase levels were impressive when one considers that this was a single dose treatment where we did not know the optimal dose. Larger scale studies are clearly warranted." The ability to dose orally is viewed as a considerable advance in the development of semapimod. Dr. Thais Sielecki, Director of Research at CPSI, commented: "As a synthetic small-molecule, semapimod holds the promise of a more cost-effective alternative to expensive and difficult-to-manufacture biologics. Oral dosing would also make treatment much easier than the IV and subcutaneous routes, which are currently the only options for many patients." The new salts have demonstrated their ability to reduce cytokine levels when given orally in a preclinical sepsis model. CPSI has recently obtained a patent on these new salts (US 7,244,765), giving considerable patent life for the reformulated product. The company is ready to move these new salts into clinical trials and is seeking a partner to assist with their development plan. http://www.medicalnewstoday.com/articles/87011.php?nfid=30587 **New CIMZIA(R) Data Demonstrates Efficacy For Up To 18 Months In Patients With Crohn's Disease, With No Dose Escalation** ---- Article Date: 30 Oct 2007 - 1:00 PDT CIMZIA(R) (certolizumab pegol), the first and only PEGylated anti-TNF therapy, has been shown to maintain remission for up to 18 months in patients with Crohn's disease, according to new data presented at the 15th United European Gastroenterology Week (UEGW). The data also showed that some patients who were re-introduced to CIMZIA after losing clinical response were re-captured with only one additional induction dose and maintained remission with no dose escalation. The findings are from analyses of two ongoing open-label, long-term extension studies of the Phase III PRECiSE programme. Of the patients who were randomised to CIMZIA (n=215) after response to open-label induction with CIMZIA in PRECiSE 2, 42 percent were still in remission after 12 months (n=90), and 37 percent were in remission up to 18 months (n=80). Over one third of the patients who had lost clinical response in the active arm of the same Phase III study were successfully recaptured with CIMZIA, achieving and maintaining remission for up to 12 months thereafter (n=17). Data from both extension studies suggest that CIMZIA continues to demonstrate an acceptable safety profile. The percentages of patients in the PRECiSE programme experiencing injection-site reactions and injection-site pain were low (<2%, <1% respectively). The most common reported adverse events in the PRECiSE studies were headache, nasopharyngitis, cough and abdominal pain.1,2 "These results demonstrated the long-term effectiveness of certolizumab pegol in patients with active Crohn's disease when treated subcutaneously every four weeks," commented study investigator Professor Stefan Schreiber, Hospital for General Internal Medicine, University-Hospital Schleswig-Holstein, Christian Albrechts University, Kiel, Germany. "The results demonstrated that re-inducing previously-relapsed patients with a single dose of certolizumab pegol may be beneficial for some patients, with a high percentage of those patients regaining long-term remission for up to a year." Quality of Life and Work Productivity An additional new analysis of PRECiSE data presented at UEGW reinforced the benefits of CIMZIA on patient quality of life. Patients enrolled in the PRECiSE 2 study were asked to complete a health status questionnaire which included self-assessment of mobility, self-care, discomfort and anxiety/depression. Results were then converted into quality of life scores. During the maintenance phase of the study, the mean utility scores were consistently higher in the CIMZIA group: 9% (p=0.007); 4% (p=0.064); and 7% (p=0.002), compared with the placebo group at weeks 16, 26 and at the withdrawal visit, respectively.3 Another new analysis of the PRECiSE data highlighted the benefits of CIMZIA on work productivity and daily activity levels. Patients enrolled in the PRECiSE 1 study completed a Work Productivity and Activity Impairment (WPAI) questionnaire, and overall scores were assessed. Results showed a significant improvement in work productivity at week 6, 16 and 26 (all p<0.05) in patients taking CIMZIA compared with the placebo group. Additionally, there was a significant reduction in activity impairment at weeks 16 and 26 (both p<0.05) in patients taking CIMZIA compared with placebo. These data represent a gain of approximately half a fully productive workday a week in the CIMZIA group, from an average of 2.4 days lost or impaired every week at the start of the study. These results demonstrate the potential benefit of CIMZIA in decreasing the economic burden of Crohn's disease.4 http://www.medicalnewstoday.com/articles/87037.php?nfid=30587 **Bowel Surgery Should Not Be Last Resort, UK Study** ---- Article Date: 01 Nov 2007 - 13:00 PDT The threshold for deciding elective surgery for inflammatory bowel diseases such as ulcerative colitis and Crohn's disease is too high says a new UK report. The result is that surgery is treated as a last resort resulting in too many emergency operations with poorer survival rates than if earlier elective surgery had been performed. The study is published in the Online First issue of the BMJ (British Medical Journal), and is the work of Dr Stephen E Roberts, Senior Lecturer in Epidemiology in the School of Medicine at Swansea University, Wales, UK, and colleagues from Swansea and Oxford. Roberts and colleagues suggested that the threshold for deciding to undertake elective surgery to take away part or all of the colon (colectomy) in patients with inflammatory bowel disease (IBD) may be too high. In the UK there are about a quarter of a million people living with IBD who will need a colectomy sooner or later. in England, about 2,000 colectomies are performed every year because of IBD. Experts have previously suggested that delaying surgery has increased risk, and it is known that death rates for elective colectomy are low. However, it has not been clear if this is due to the threshold criteria for when surgery should be performed being too high, resulting in delayed decisions to operate and more emergency operations. Roberts and colleagues investigated hospital records throughout England (from 1998 to 2003) to find the mortality rate following colectomy for IBD. They compared rates of elective colectomy, emergency colectomy and rates of hospitalization for IBD that was not followed by colectomy. The researchers gathered records on a total of 23,464 patients who had spent more than three days in hospital because of IBD and of whom 5,480 had a colectomy. They also traced records on the participants who died up to three years after being admitted to hospital. The results showed that: * Long term survival for elective colectomy was better than that for emergency or no colectomy. * There was a substantially greater risk of dying shortly after emergency colectomy. * At three years, the increased risk of death among patients who did not have a colectomy was almost as high as among those who had an emergency colectomy. * However, patients who had elective colectomies has a similar rate of survival as the general population. * Adjustment for other illnesses occuring in the patients did not affect the results. The researchers conclude that: "In England, the clinical threshold for elective colectomy in people with inflammatory bowel disease may be too high. Further research is now required to establish the threshold criteria and optimal timing of elective surgery for people with poorly controlled inflammatory bowel disease." The authors said their findings supported the idea that whenever possible, it was better to opt for elective colectomy rather than incur delay and risk emergency colectomy which has a poorer prognosis. They called for further studies to establish the threshold criteria and help define the right timing for people with badly controlled IBD to have an elective colectomy. An accompanying editorial said the findings should act as a word of caution to those who promoted surgery for IBD as a last resort. http://www.medicalnewstoday.com/articles/87444.php?nfid=30587 **Can-Fite: CF101 May Be Effective For The Treatment Of Crohn's Disease** ---- Article Date: 08 Nov 2007 - 6:00 PST Can-Fite BioPharma (TASE:CFBI), a biotechnology company traded on the Tel Aviv Stock Exchange, reports today that its CF101 drug may also be used to treat Crohn's disease, a serious gastrointestinal disorder. Can-Fite will present these findings at the annual meeting of the American College of Rheumatology (ACR) later this week. Can-Fite reports that pre-clinical studies show that the A3 adenosine receptor, which is targeted by CF101, is over-expressed in bowel tissue and peripheral blood mononuclear cells derived from patients with Crohn's disease. These findings are in line with previous data showing the efficacy of CF101 as an anti-inflammatory agent in pre-clinical models of inflammatory bowel diseases. The presence of this receptor on the surface of the affected cells of patients with Crohn's disease strongly suggests that this patient population may benefit from CF101 which binds to the receptor and leads to apoptosis of the inflammatory cells. It should also be underlined that, similar to other indications under development, the drug exerts a differential effect on inflammatory normal cells. Crohn's disease is an autoimmune inflammatory condition that primarily affects the small intestine. This disease is characterized by recurrent inflammation, intestinal adhesion and bowel obstruction. The disease, which is chronic and incurable, usually presents in adolescence or early 20's. The current standard of treatment includes steroids and biological drugs e.g. Remicade (anti-TNF) that relieve disease symptoms but may induce adverse events. Similar to the biological drugs that were initially registered for the treatment of rheumatoid arthritis and recently shown to be effective in Crohn's disease, CF101 may also be suitable for development as treatment for this disease due to its similar mechanism of action. Unlike biological drugs that are administered by infusion or injection, CF101 is supplied as an oral drug and has an excellent safety profile. Can-Fite notes that the number of Crohn's patients in the US alone is currently estimated at over 500,000 and that about 20,000 new patients are diagnosed each year. The size of this market in the US alone is estimated at approximately $5 billion. This ACR convention, where Can-Fite presents its findings, is the single most important convention in rheumatology, with attendance by about 15,000 rheumatology physicians and investigators from around the world. This convention, which covers novel rheumatological drug development, attracts leading pharmaceutical companies involved in the development of such drugs. Can-Fite will also present in this convention new data on the progress of its third pipeline drug, CF502. This drug is a next-generation drug developed for autoimmune indications. This drug is in the preclinical phase of development after proof of concept that has been demonstrated in laboratory trials that showed potent anti-inflammatory activity on human cells. Can-Fite announced this month that it will proceed with the development of CF101 for the treatment of rheumatoid arthritis. The Company reported the planned initiation in early 2008 of a confirmatory phase IIb trial to further develop this drug, following a July report on the significantly favorable responses observed in certain disease parameters during the first Phase IIb studies with CF101. Can-Fite estimates that this trial will be initiated in the first quarter of 2008 and completed, including result compilation and analysis, in about one year. Alongside with the development in CF101, Can-Fite recently reported the successful completion of preclinical trials in the US with CF102, its second pipeline molecule, designed for the treatment of liver conditions such as liver cancer, hepatitis and for liver regeneration. Can-Fite estimates that the clinical phase of trials with CF102 will commence in the coming months. Can-Fite BioPharma"" LTD is a public company traded on the Tel Aviv Stock Exchange. The Company, which commenced business activity in 2000, was founded by Prof. Pnina Fishman, an investigator from Rabin Medical Center, and patent attorney Dr. Ilan Cohn, a senior associate at Reinhold Cohn Patent Attorneys. Prof. Fishman serves as the CEO of Can-Fite. The Company was founded on the basis of scientific findings made by Prof. Fishman and focuses on the development of molecule-based drugs that bind to receptors of cancerous or inflammatory cells and inhibit their development.

Can-Fite currently has two drugs in development, CF101 and CF102. The company is simultaneously conducting several clinical and preclinical trials with the two drugs for various indications. CF101 is being studied for the treatment of rheumatoid arthritis, dry eye syndrome and psoriasis. Can-Fite has also entered the development of CF102 for the treatment of liver cancer and hepatitis.

http://www.canfite.com/
http://www.medicalnewstoday.com/articles/88062.php?nfid=30587

UCB To Appeal European Negative Opinion On CIMZIA(R) For The Treatment Of Patients With Crohn's Disease

Article Date: 16 Nov 2007 - 11:00 PST

UCB announced that it has been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the market authorisation application (MAA) in the EU for CIMZIA(R) certolizumab pegol) in the treatment of patients with Crohn's disease.

UCB plans to utilise the appeal process to request a CHMP re-examination of the submission. A decision is expected during the first half of 2008.

"UCB is disappointed by the CHMP decision, but remains confident in the efficacy and tolerability of CIMZIA?. UCB will continue to work with the CHMP to address the Committee's concerns to obtain its endorsement to allow this treatment option to be available to people suffering from Crohn's disease." said Melanie Lee, Executive Vice President Research & Development of UCB.
http://www.medicalnewstoday.com/articles/89092.php?nfid=30587

CHMP Adopts Negative Opinion On Appeal On European Application For Natalizumab For The Treatment Of Crohn's Disease

Article Date: 19 Nov 2007 - 0:00 PST

Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has adopted a negative opinion on the marketing authorization for natalizumab as a treatment for Crohn's disease. This decision is on the appeal the companies filed following a previous negative opinion adopted by the CHMP earlier in 2007.

This negative opinion is now referred to the European Commission (EC), which grants marketing authorizations in the EU. Final EC decisions customarily follow the CHMP's recommendation, and the companies expect to hear from the EC during the first quarter of 2008.
http://www.medicalnewstoday.com/articles/89163.php?nfid=30587

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