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| |  Extract of Patient's Own Colonic Mucosal Proteins Effective in Crohn's Disease, Study Finds By W.A. Thomasson, PhD CHICAGO, IL -- May 19, 2005 -- Patients with Crohn's disease who receive an injection of a protein-containing extract made from tissue removed from their own colon appear to achieve disease remission. Lead author Maya Margalit, MD, a researcher at Hadassah Hebrew University, Jerusalem, Israel, presented the findings here on May 18th at Digestive Disease Week (DDW). Dean Engelhard, PhD, executive vice president, Enzo Biochem, Farmingdale, New York, discussed the findings at a press conference on May 18th. The study was sponsored by Enzo Biochem. The extract, tradenamed Alequel(TM), is obtained from a biopsy and prepared by a proprietary method that requires approximately 2 days and is then administered orally. The study randomized 31 patients with moderate or severe Crohn's disease to 27 weeks of either Alequel treatment or placebo. Clinical remission was seen in 58% of Alequel-treated patients and 29% of placebo patients. Clinical responses were seen in 67% and 43%, respectively. Health-related quality of life as measured with the Inflammatory Bowel Disease Questionnaire improved by 43% with Alequel and 12% with placebo. No treatment-related adverse events were noted. Patients who responded to Alequel treatment had higher baseline blood levels of NKT and CD4+ T cells and lower baseline levels of CD8+ T cells and C-reactive protein compared with patients who did not respond, Dr. Engelhardt said. Indeed, he added, almost all patients who fit this profile responded to Alequel. Enzo Biochem is adding new patients to its ongoing study to confirm the findings of this study, Dr. Engelhardt said. If the predictive value seen in this study is confirmed, it will be a useful screening tool to identify potential candidates to receive this treatment.
[Presentation title: A Double-Blind Clinical Trial for Treatment of Crohn's Disease by Oral Administration of Alequel(TM), a Mixture of Autologous Colon Extracted Proteins: a Patient-Tailored Approach. Abstract W1042]
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