Enzo Biochem Initiates Clinical Trial for Treatment of Uveitis at NIH

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Study of Optiquel(TM), a Proprietary Therapeutic to be Conducted By the National Institute of Health's National Eye Institute

NEW YORK--(BUSINESS WIRE)-- Enzo Biochem, Inc. (NYSE: ENZ), announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel(TM) , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI). Robert Nussenblatt, MD, Chief of NEI's Laboratory of Immunology, will serve as Principal Investigator.

Optiquel(TM) has been awarded orphan drug status in the European Union and a similar designation may be applied for in the US. Enzo owns the exclusive rights to both US and international patents claiming the use of this compound for the treatment of uveitis. An investigator-initiated clinical trial of Optiquel(TM) in Germany demonstrated a therapeutic effect with no treatment-related side effects.

Uveitis is a collective term for a variety of ophthalmic conditions that result in chronic inflammation of the eye involving the uvea, which lies between the outermost and innermost layers of the eye. Uveitis occurs most frequently in relatively young 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 that the disease is associated with 30,000 cases of blindness annually. It has been estimated that 10-22% of new cases of blindness in the United States result from this disease.

Patients with chronic autoimmune uveitis often require immunosuppressive treatment for an extended period of time. Furthermore, immunosuppressive therapy is frequently associated with side effects, including glaucoma and cataracts that limit the duration and intensity of treatment.

Optiquel(TM), by contrast, has been designed as a novel and specific immune modulator that utilizes a highly specific down-regulation of the uveitis autoimmune response by oral treatment with an antigen that is very nearly identical to the offending antigen. This tolerogenic approach with Optiquel(TM) is based on Enzo's proprietary oral immune regulation platform, a platform that has been studied extensively across a number of clinical indications.

"We are pleased to announce the initiation of this clinical trial, and that it will be performed at the National Eye Institute," said Elazar Rabbani, Ph.D., Chairman and CEO of Enzo Biochem. "Chronic non-infectious uveitis is currently treated with steroids and other general immune suppressive therapy, often producing serious and damaging side effects. Optiquel(TM), if it meets its endpoints of reducing the need for high doses of steroid treatment in order to reduce symptoms and improve visual acuity, would represent a significant step forward in the treatment of this affliction."

About Enzo Biochem

Enzo Biochem, Inc., is a growth-oriented integrated life sciences and biotechnology company focused on harnessing biological process to develop research tools, diagnostics and therapeutics, and serves as a provider of test services, including exotic tests, to the medical community. Since our founding in 1976, our strategic focus has been on the development of enabling technologies in the life sciences field. Enzo Life Sciences 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 worldwide. Enzo Clinical Labs provides laboratory services for a growing roster of physicians in the New York Metropolitan area, Pennsylvania and New Jersey. Its tests include, in addition to routine tests, capabilities for detecting molecular infection disease, molecular oncology, autoimmune disorders and genetics. Enzo Clinical Labs also provides clinical diagnostic services that allow Enzo to capitalize on its extensive advanced molecular and cytogenetic capabilities and the broader trends in predictive and personalized diagnostics. Enzo Therapeutics is a biopharmaceutical venture that has developed multiple novel approaches in the areas of gastrointestinal, infectious, ophthalmic and metabolic diseases. It has focused its efforts on developing treatment regimens for diseases and conditions for which current treatment options are ineffective, costly, and/or cause unwanted side effects. In the course of the company's research and development activities, Enzo has developed a substantial portfolio of intellectual property assets, with over 240 issued patents worldwide and over 200 pending patent applications.

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, including those related to cash flow, gross margins, revenues, and expenses are dependent on a number of factors outside of the control of the company including, inter alia, the markets for the Company's products and services, costs of goods and services, other expenses, government regulations, litigations, and general business conditions. See Risk Factors in the Company's Form 10-K for the fiscal year ended July 31, 2009. 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 October 4, 2010