Data From Enzo Therapeutics' Phase II Study Of Crohn's Disease Presented At Prestigious Gastroenterology Conference

Main Category: Crohn's
Also Included In: GastroIntestinal / Gastroenterology;  Clinical Trials / Drug Trials
Article Date: 04 Jun 2009 - 6:00 PDT

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Enzo Biochem, Inc. (NYSE: ENZ), a biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications and laboratory services, announced that data from a Phase II clinical trial was presented today at Digestive Disease Week, the largest international gathering of academic researchers and practicing physicians in gastrointestinal medicine, held this year in Chicago. The data indicate that Alequel™, the Company's investigational individualized oral immune regulation preparation, may be effective for the treatment of moderate-to-severe Crohn's disease.

Medical researchers from Hebrew University-Hadassah Medical Center, Jerusalem, Israel, presented an abstract titled, "Oral Administration of Alequel™, a Mixture of Autologous Colon-Extracted Proteins for Treatment of Crohn's Disease: Results of a Double-Blind Clinical Trial," which highlighted data from a study, sponsored by Enzo Therapeutics, a wholly-owned subsidiary of Enzo Biochem. Subjects (n=43) with moderate to severe Crohn's disease were enrolled in a randomized, placebo-controlled, double-blind clinical trial. Subjects were randomized to receive either placebo or Alequel™ over a period of 15 weeks. The subjects were monitored for Crohn's Disease Activity Index (CDAI), Inflammatory Bowel Disease Questionnaire (IBDQ) and a number of potential surrogate biomarkers.

The primary endpoint was the remission rate, defined as a CDAI score of 150 or less at 2 consecutive time points 3 weeks apart. The remission rate was calculated for evaluable patients at 3-week intervals. Measuring between weeks 6 and 9, 43% of the investigational drug recipients met the criteria for clinical remission, versus 31% of the placebo recipients. For weeks 9 to 12, the remission increased to 50% of subjects receiving the investigational drug compared to 31% in the placebo group. Mean percent change in IBDQ quality-of-life score was 3 times greater after 15 weeks of treatment for subjects treated with Alequel™ compared to placebo.

To evaluate possible surrogate markers for the clinical effect of the drug, peripheral blood T-cell subpopulations were analyzed for each subject.

The data presented indicate a decrease in both peripheral NKT regulatory cells and the CD4+/CD8+ T lymphocyte ratio in subjects receiving Alequel™ who responded positively to the test drug, compared to subjects receiving Alequel™ who did not respond positively. A decrease of 28% vs an increase of 16% in peripheral NKT regulatory cells, and a decrease of 15% vs. an increase of 11% in the CD4/CD8 lymphocyte ratio, in drug responders vs. non responders respectively were noted only in subjects with a significant clinical response. It is believed that these immune cells may serve as surrogate markers to predict those individuals who would respond to the treatment. The applicability of these surrogate markers is being considered for further study.

The study also met secondary endpoints for improved quality of life as measured by IBQD scores, as well as overall safety and tolerability. No treatment-related adverse events were noted.

"We are pleased with the results of this clinical trial," said Elazar Rabbani, PhD, CEO of Enzo. "Alequel™ is a unique investigational drug in that it is designed to harness the patient's own immune system to alleviate symptoms of Crohn's disease, suggesting a new approach for a disease with few current treatment options. Alequel™ is designed to reduce the patient's dependence on systemic immunosuppressant drugs that often have undesirable side effects. Alequel appeared to be well-tolerated and improved the individual's quality of life. We believe these results further validate the potential for Alequel and we are examining our options to maximize the opportunities for this program."

About Crohn's disease

CD is an idiopathic, immune-mediated disorder currently believed to result from a cascade of processes initiated by unidentified antigens. This inflammatory disease of the GI tract affects approximately 500,000 people in the United States and at least that many in the rest of the world. The disease is characterized by flare-ups of symptoms such as diarrhea, abdominal pain, rectal bleeding and loss of appetite, alternating with periods of remission. Systemic complications of chronic disease include weight loss, anemia and increased risk of bowel cancer.

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