"Given our current understanding of Crohn's disease as an inappropriate autoimmune response in the GI tract, we are developing Alequel as an individualized oral treatment that harnesses the patient's own immune system to alleviate symptoms," said Gary C. Cupit, PharmD, President of Enzo Therapeutics. "Many Crohn's patients are frustrated with current treatment options; Alequel is designed to reduce patients' dependence on systemic immunosuppressant drugs. The interim Phase II results encourage us to advance beyond these two studies presented this week at DDW. Thus, we are planning to expand into more advanced studies in the United States."
About the Clinical Studies
These two double-blind, placebo-controlled studies randomized 49 subjects with moderate-to-severe Crohn's disease as measured by the Crohn's Disease Activity Index (CDAI). Alequel(TM) therapy consists of oral administration of an autologous protein-containing extract, individually prepared from mucosal tissue colon biopsies of the subject obtained through colonoscopy (a common procedure for Crohn's patients). In one trial , subjects received a regimen of 3 weekly doses for 15 weeks of either active treatment or placebo; in the other trial, all subjects received placebo for 3 weeks and then 12 weeks of either active treatment or placebo. Forty subjects were evaluated for an additional 6 weeks after the treatment period.
Outcome measures included clinical remission and response measured by CDAI score, quality of life measured using the Inflammatory Bowel Disease Questionnaire (IBDQ), and investigation of a number of potential surrogate biomarkers. Rates of remission and response nearly doubled for evaluable subjects treated with Alequel(TM) compared to placebo, although, due to the size of the studies, the differences were not yet statistically significant. Enzo is currently enrolling additional patients in the trials. Mean percent change in IBDQ quality-of-life score was 3 times greater for patients treated with Alequel(TM) compared to placebo. Treatment was well tolerated, with no treatment-related adverse events reported.
About Crohn's disease (CD)
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.
In addition to Alequel, Enzo Therapeutics is developing therapies for HIV/AIDS and non alcoholic steatohepatitis (NASH) and uveitis, as well as conducting pre-clinical research on candidate therapies for osteoporosis and fractures, among other applications. Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering techniques, as well as providing diagnostic services to the medical community. The company's proprietary labeling and detection products for gene sequencing and genetic analysis are sold to the life sciences market throughout the world. Enzo Biochem owns or licenses over 200 patents worldwide.
Except for historical information, the matters discussed in this news release may be considered "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.
For Enzo Biochem, Inc.
Steve Anreder, 212-532-3232
Ed Lewis, 212-732-4300
For Enzo Therapeutics, Inc.
Ellen M Martin, 510-832-2044