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ENZO Biochem Comments on FDA Action

FARMINGDALE, N.Y.--(BUSINESS WIRE)--Jan. 15, 2003--Enzo Biochem, Inc. (NYSE: ENZ - News) today commented on the Food and Drug Administration's precautionary measure placing a temporary "clinical hold" on all active gene therapy trials using retroviral vectors to insert genes into blood stem cells.

The FDA said it initiated the action after learning that a second "X-SCID" child, commonly known as "bubble baby syndrome," treated in a French gene therapy trial had developed a leukemia -like condition. The FDA noted, that in its continuing review of adverse event reports from all U.S. studies involving retroviral vectors, it has to date found no evidence of leukemia caused by gene therapy.

 

Enzo's HGTV43 gene regulation construct, which uses retroviral vectors for its delivery to blood stem cells, differs materially from the construct used in the French gene study. Furthermore, the five subjects treated in Enzo's Phase I HGTV43 trial have been followed for up to three years and to date there has been no treatment-related serious adverse events, including leukemia.

 

It should be noted that HIV continues to be on the rise in the U.S. as well as the rest of the world and that it remains a major problem with limited long-term treatment options. The Company plans to proceed with its goal of management of HIV infection through its gene transfer technology in compliance with FDA guidelines.

 

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 conducting clinical trials of its proprietary gene medicine for HIV-1 infection and clinical trials of 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.enzobiochem.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.