Drug Treatments Hold Promise for Crohn’s Disease

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Drug Treatments Hold Promise for Crohn’s Disease

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New Drug Treatments Hold Promise for Crohn’s Disease and Hepatitis C PatientsHealth Outcomes Explored at DDW® 2010NEW ORLEANS, LA (May 4, 2010) – Research being presented at Digestive Disease Week® (DDW®) shows that using telaprevir in the treatment regimen for hepatitis C virus (HCV) is highly effective, particularly in difficult-to-treat cases. Further studies show that aspirin may be a factor in the development of inflammatory bowel disease. DDW is the largest international gathering of physicians and researchers in the field of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

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DDW/Final Results of A Rollover Study Assessing Telaprevir in Combination with Peginterferon Alfa-2A and Ribavirin in Chronic Hepatitis C.Aspirin in the Etiology of Crohn's Disease and Ulcerative Colitis - Results from a European Prospective Cohort Study (Abstract #96)Regular aspirin use may be one of many factors involved in the development of Crohn’s disease, according to new research from the University of East Anglia in the U.K. Crohn’s disease is a serious condition that causes inflammation and swelling in any part of the digestive system that can result in debilitating symptoms. Previous experimental research has shown that aspirin can directly damage the bowel wall, impair its energy

supply and possibly limit the bowel’s blood supply.Researchers led by Hart, MD, senior lecturer in gastroenterology at the University of East Anglia, analyzed data from the European Prospective Investigation into Cancer & Nutrition (EPIC) of more than 200,000 healthy participants from European countries for risk factors involved in the development of Crohn’s disease and ulcerative colitis (UC). A total of 62 participants developed Crohn’s disease and 126 developed UC. By comparing the frequency of regular aspirin use in participants who developed Crohn’s disease and UC and those who did not, researchers found regular aspirin use was positively associated with the risk of developing Crohn’s disease. There was no association between aspirin use and UC.The findings demonstrate that participants who took aspirin regularly for at least one year were nearly five times more likely to be diagnosed with Crohn’s

disease than those who did not. However, smokers in the study who took aspirin did not develop Crohn’s, even though smoking by itself is seen as a risk factor of the disease. Researchers hypothesize that the blood-thickening effects of smoking and the blood thinning effects of aspirin may counteract the harmful properties of both."This work suggests that regular use of aspirin may be one of many factors in the development of some cases of Crohn’s disease," said Dr. Hart. "We are working to understand the etiology of Crohn’s disease looking at many factors including aspirin and diet."These results need to be tested in different populations in the world before a definitive link can be made. Dr. Hart and colleagues caution that not everyone taking aspirin will develop Crohn’s disease and that aspirin has many beneficial effects, including helping to prevent heart attacks and strokes.Dr. Simon Chan will

present these data on Sunday, May 2 at 10:45 a.m. CT in 295-296, Ernest N. Morial Convention Center.Chemokine Receptor Antagonist CCX282-B (Traficet-EN) Maintained Remission of Crohn's Disease in PROTECT-1 Study (Abstract #647)New research from the PROTECT-1 study (Prospective Randomized Oral Therapy Evaluation in Crohn’s Disease Trial) demonstrates the effectiveness of Traficet-EN (CCX282- in maintaining remission of Crohn’s disease over 36 weeks. Previously the drug was shown to reduce the severity of Crohn’s disease in a 12 week induction study.PROTECT-1 is a double-blind placebo-controlled trial of 436 patients with moderate to severe Crohn’s disease, a condition that causes inflammation and swelling in the digestive system that can result in debilitating symptoms. Traficet-EN targets the chemokine receptor 9 (CCR9) that is involved in attracting

specific inflammatory cells to the gastrointestinal tract during inflammatory bowel disease. The drug targets specific cells that are involved in this inflammatory condition of Crohn’s disease, while leaving the rest of the immune system unaltered.Following the 12-week induction study, patients who experienced at least a 70 point reduction on the Crohn’s Disease Activity Index were re-randomized to examine Traficet-EN efficacy in maintaining remission of the disease. For this period of the study, 241 patients were re-randomized: 146 received Traficet-EN and 95 received placebo. Traficet-EN maintained remission rate at ~50 percent, whereas the remission rate in patients on placebo decreased progressively from 50 percent at baseline to 31 percent at 36 weeks. At 36 weeks, 47 percent of subjects on Traficet-EN were in remission, constituting a statistically significant difference (p=0.01).In addition to greater remission levels,

patients taking Traficet-EN required less corticosteroid therapy compared to placebo. In patients with Crohn’s disease, symptoms typically flare up, often requiring initiation or increase of corticosteroids. At 36 weeks, 41 percent of subjects on Traficet-EN were in corticosteroid-free remission versus 28 percent on placebo (p=0.04)."Traficet-EN’s efficacy as an oral treatment in preserving remission in people with Crohn’s disease is a significant advance in the treatment of this disease," said Pirow Bekker, MD, PhD, senior vice president of medical and clinical affairs at ChemoCentryx. "In addition to being a novel therapeutic approach for treating Crohn’s disease, this study validates the selective targeting of chemokine receptors to treat major inflammatory and autoimmune diseases."Current treatments available for Crohn’s disease are administered intravenously or by injection, whereas Traficet-EN is an oral capsule.

Steroids are also often used in the treatment of Crohn’s disease. While they are effective at reducing symptoms of the disease, they have significant side effects including osteoporosis and increased risk of infection. Additionally, over the course of treatment, Traficet-EN was well tolerated by patients and there were no reports of serious infections.Dr. Bekker noted that this study did not directly compare Traficet-EN to other drugs, so the relative efficacy and safety of the compound compared to other treatments are unknown at this time. The study was funded by ChemoCentryx, which is developing Traficet-EN.Satish Keshav, MD, PhD will present these data on Tuesday, May 4 at 11:15 a.m. CT in Auditorium AB, Ernest N. Morial Convention Center.# # #Digestive Disease Week® 2010 (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology,

hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the AGA Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 1 – May 5, 2010 in New Orleans, LA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

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