Enzo Biochem Announces Approval for Phase II Double-Blind Clinical Trial of EGS21 for Non-Alcoholic Steatohepatitis (NASH).

FARMINGDALE, N.Y. -- Enzo Biochem, Inc. (NYSE:ENZ) announced today that it has received regulatory approval from the Helsinki Committee of Hebrew University-Hadassah Medical Center in Jerusalem, Israel to initiate a Phase II randomized double-blind clinical trial of EGS21 for the treatment of non-alcoholic steatohepatitis (NASH) or fatty liver disease.

This clinical trial is based on successful preclinical studies carried out by Enzo scientists and collaborators followed by a Phase I safety trial of the study drug and a pilot open label clinical trial that showed positive trends towards a possible therapeutic effect of EGS21. This study is being partially funded by a $1.0 million grant from the Israel-U.S. Binational Industrial Research and Development Foundation (BIRD) and is expected to be initiated shortly.

Nonalcoholic fatty liver disease is one of the most common causes of liver pathology in the United States. NASH is one stage in a disease spectrum that ranges from simple fatty liver or steatosis to steatohepatitis, advanced fibrosis, and end-stage cirrhosis. It is estimated that approximately 8.6 million obese adult Americans may have NASH and that another 30.1 million may have the milder form of fatty liver.

The causes of NASH are not well defined, but the disease usually occurs together with obesity, type II diabetes and hyperlipidemia. The disease is estimated to affect 19% of the obese population and almost half of morbidly obese individuals; although about 3% of the lean population may also be affected. The Centers for Disease Control has estimated that the prevalence of obesity in U.S. adults 20 years and older increased about 1% per year over the period 1997 to 2002 and the Company believes it is reasonable to assume that the increase is continuing.

There is no effective medical therapy currently available for patients with non-alcoholic fatty liver disease.

Enzo's preclinical laboratory studies suggested that NASH is an immune mediated disease. EGS21 was shown to alleviate the symptoms of the disease and its associated metabolic syndrome in the animal model systems. Administration of the compound to the experimental animals led to significant reductions in the hepatic fat content (as assessed by MRI and liver biopsies), body weight, and serum liver enzyme levels as well as marked improvement of the glucose tolerance test and lipid profile. The results of these studies were presented at several international meetings and demonstrated that EGS21 acts on the immune regulatory (NKT) cells and therefore could impact the immune response in the body by modulating its function and adjusting it to a normal state.

Along with the NASH study, Enzo Therapeutics is continuing to pursue its drug development programs. An expanded Phase II study currently in progress will compare EGS21 with Alequel(TM), the Company's therapeutic modality for management of Crohn's disease, another immune mediated disease. The Phase I/II clinical study of HGTV-43(TM), Enzo's gene medicine for HIV-1 infection has been initiated at the University of California San Francisco. Enzo is preparing to submit a protocol for a Phase I/II study of B27PD, the Company's therapy for autoimmune uveitis. In addition, the Company has a number of new compounds in preclinical development that could provide therapy for treating bone disorders including osteoporosis, bone loss, fractures, abnormalities, diseases, and other applications.

About Enzo

Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering techniques, and in 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. The Company's therapeutic division is in various stages of clinical evaluation of its proprietary gene medicine for HIV-1 infection and its proprietary immune regulation medicines for hepatitis, uveitis, Crohn's disease, and for NASH and its associated metabolic syndrome. Pre-clinical research is being conducted 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. The Company also holds a patent covering a method and materials for correcting point mutations or small insertions or deletions of genetic material that would allow for editing and correcting certain abnormalities in genes. The Company owns or licenses over 200 patents worldwide. 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.