Enzo Biochem and National Institutes of Health to Cooperate in Development of Enzo's Novel Therapeutic Candidate for Treatment of Autoimmune Uveitis

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NIH to Conduct Clinical Trial with Optiquel(TM)

NEW YORK--(BUSINESS WIRE)-- Enzo Biochem, Inc. (NYSE: ENZ), announced today that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Eye Institute, part of the National Institute of Health, to conduct a human clinical trial of Optiquel(TM), Enzo's oral, proprietary therapeutic for chronic autoimmune uveitis.

Under the terms of the CRADA, Enzo will supply its proprietary compound, Optiquel(TM), and will fund a portion of the studies. The clinical trial will be conducted to assess the safety and efficacy of Optiquel(TM) in a proof-of-concept clinical trial designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up. The agreement additionally includes non clinical research focusing on the use of various compounds that may serve to enhance the immune mediated oral tolerance response to specific antigens. Such research may be applicable across the entire spectrum of the Company's immune regulation platform, including Alequel(TM), and EGS21(TM), its therapeutic candidates for the treatment of Crohn's Disease and NASH, respectively.

Robert Nussenblatt, MD, Chief of NEI's Laboratory of Immunology, will serve as the Principal Investigator on this project. Dr Nussenblatt, a world-renowned ocular immunologist and expert in clinical research design and conduct, has authored or co-authored over 400 publications and a number of books, including a standard text on uveitis.

An autoimmune disorder is a malfunction of the immune system which causes it to attack itself. In autoimmune uveitis, the body's own immune system attacks the uvea of the eye, the portion of the eye that lies between the outermost and innermost layers of the eye. Uveitis occurs most frequently in people ages 20 to 50. A recent study estimated that more than 280,000 people in the United States are affected by uveitis each year, and the disease is associated with 30,000 cases of blindness annually.

Patients with chronic autoimmune uveitis are currently treated with general immunosuppressive agents such as steroids. The aim of immunosuppression is to control inflammation and to preserve visual acuity. However, immunosuppression therapy is frequently associated with significant adverse effects, including ocular toxicity (glaucoma and cataract), that limit the duration and intensity of treatment. Therefore, there exists an urgent need for new, non-general and specific therapeutic approaches with less material side effects.

Optiquel(TM) has been designed as such a therapeutic approach as it specifically targets the HLA proteins. A Phase I study of Optiquel (TM) showed no treatment related side effects. Optiquel(TM) therapy is based on oral tolerance, an immunologic mechanism that down-regulates immune responses in an antigen-specific manner, rather than a non-specific immunosuppressive approach. A Phase I study of Optiquel(TM) demonstrated a therapeutic effect with no treatment-related side effects. Optiquel(TM) has been awarded orphan drug status in the European Union and it is anticipated that a similar designation will be applied for in the US. Enzo has exclusive rights to both US and international patents claiming the use of this compound for the treatment of uveitis.

Enzo will sponsor an investigational new drug (IND) application and submit it to the FDA. Additionally, Enzo has completed all of the bulk manufacturing, stability studies, pharmacokinetics evaluations, and formulation in capsules, as well as prepared the necessary documentation to treat patients. Toxicity studies have all proven negative.

About NEI and NIH

The National Eye Institute (NEI) is part of the National Institutes of Health (NIH) and is the Federal government's lead agency for vision research that leads to sight-saving treatments and plays a key role in reducing visual impairment and blindness. For more information, visit the NEI Website at www.nei.nih.gov.

The National Institutes of Health (NIH) - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary Federal agency for conducting and supporting basic, clinical, and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

About Enzo

Enzo Biochem is engaged in the research, development, manufacture and licensing of innovative health care products and technologies based on molecular biology and genetic engineering techniques, and in providing diagnostic services to the medical community. Enzo's Life Sciences division develops, produces and markets proprietary labeling and detection products for gene sequencing, genetic analysis and immunological research among others. Its catalog of over 30,000 products serves the molecular biology, drug discovery and pathology research markets. The Company's therapeutic division is in various stages of clinical evaluation of its proprietary immune regulation medicines for uveitis and Crohn's disease and conducts pre-clinical research on several candidate compounds aimed at producing new mineral and organic bone, including technology that could provide therapy for osteoporosis and fractures, among other applications. Enzo's Clinical Labs division provides routine and esoteric reference laboratory services for physicians in the New York Metropolitan and New Jersey areas. Underpinning the Company's technology and operations is an extensive intellectual property estate in which Enzo owns or licenses over 240 patents worldwide, and has pending applications for over 200 more. For more information visit our website www.enzo.com.

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. 


    Source: Enzo Biochem, Inc.

Released September 21, 2009