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Phase I/II Hiv Gene Therapy Trial Initiated Enzo Biochem Tells Annual Meeting

NEW YORK, NY, January 14, 2004 – Enzo Biochem, Inc. (NYSE:ENZ), a leading biotechnology company specializing in gene identification and genetic and immune regulation technologies for diagnostic and therapeutic applications, said today that the Phase I/II study of its Stealth Vector® HGTV43™ gene construct for HIV infection has been initiated at New York Presbyterian Hospital-Weill Medical College of Cornell University.
 
Speaking at the Company’s annual meeting of shareholders, Barry W. Weiner, President, said that the gene therapy trial, while holding important implications in treating individuals infected with HIV, could also be applicable to a broad spectrum of other infectious diseases.  The objective of the current trial is to increase the number of engineered cells containing the anti-HIV-1 antisense RNA genes in circulation. 
 
“For the last three years, ever since the Phase I trial demonstrated the safety of the HGTV43™ gene construct and the ability of the engineered cells to survive and function in vivo, Enzo has worked diligently, conducting literally hundreds of additional tests designed to assure the safety of our medicine, to reach this stage,” commented Mr. Weiner.   “Now, while we await the results of the current study, we can look back and take great pride that we have advanced to this level of development, something that few others have accomplished.  The sustained expression of our HGTV43™  gene construct in circulating CD4+T-cells strengthens our belief that this gene therapy protocol could function as a once in a lifetime treatment.”
 
Mr. Weiner also noted that gene regulation is one of five therapeutic platforms Enzo is actively pursuing.  In addition to gene regulation, the other four platforms are:  (1) immune regulation, applicable to immune mediated diseases, including Crohn’s Disease, for which Enzo is testing a potential drug in the final stages of a double-blind Phase II trial, hepatitis B virus-associated chronic active hepatitis, for which Enzo’s EHT899 drug has been evaluated in both a Phase I and Phase II open label study, NASH (non-alcoholic steatohepatitis or fatty liver) and obesity;  (2) immune potentiation, an additional platform for immune mediated diseases, centered around an intermediate metabolite called glucosylceramide; (3) in vitro cell training, involving the treatment of cells outside the body and administering these treated cells; and (4) gene editing, a procedure for correcting inborn errors of metabolism.
 
Enzo Life Sciences, Mr. Weiner reported, has expanded its direct selling organization aimed at marketing the Company’s BioArray™ line of products to the genomics market.   “The decision to focus our own sales group on reaching this growing market is clearly an important strategic decision for the Company,” he said.
 
At the meeting, shareholders re-elected as directors Shahram K. Rabbani, Chief Operating Officer and Secretary, and Irwin C. Gerson, a former Chairman of Lowe McAdam  Healthcare, one of the largest advertising agencies specializing in pharmaceutical marketing and advertising.  Ernst & Young LLP was ratified as the independent auditors for the Company for fiscal 2004.
 
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, with approximately 200 patents worldwide, 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 B and hepatitis C infection and for Crohn’s Disease.  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.  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.