(BW) (ENZO-BIOCHEM)(ENZ) Enzo Biochem Receives FDA Clearance to Begin Human Clinical Trials of Genetic Anti-HIV Medicine; Enzo Therapeutics Granted IND for Testing First-of-Kind Genetic Antisense Business Wire
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(BW) (ENZO-BIOCHEM)(ENZ) Enzo Biochem Receives FDA Clearance to Begin Human Clinical Trials of Genetic Anti-HIV Medicine; Enzo Therapeutics Granted IND for Testing First-of-Kind Genetic Antisense

BUSINESS WIRE; Tuesday, March 31, 1998


FARMINGDALE, N.Y.--(BUSINESS WIRE)--March 31, 1998--Enzo Biochem, Inc. (AMEX:ENZ) announced today that its wholly owned subsidiary, Enzo Therapeutics, has received clearance from the Food and Drug Administration (FDA) for an Investigational New Drug application (IND) to initiate human clinical testing of Enzo's newly developed medicine which is designed to stop the growth of HIV-1.

Known as HGTV43, Enzo's new medicine incorporates two proprietary technologies. The first involves the insertion of a piece of genetic material into blood cells in order to inhibit the growth of HIV-1, the virus that causes AIDS. This technology, known as genetic antisense, utilizes a "mirror image" of a gene, called an antisense molecule, to block the virus. The second technology is based on a novel vector designed to deliver the antisense molecule to the cell.

"We are pleased to begin human trials of Enzo's first therapeutic compound for the treatment of HIV," said Elazar Rabbani, Ph.D., Enzo's Chairman and Chief Executive Officer. "This trial brings to reality Enzo's therapeutic program, moving Enzo Therapeutics into a product development stage complimenting the progress in our two profitable divisions, Enzo Diagnostics and Enzo Clinical Labs."

A key aspect of Enzo's therapeutic approach has been the development of a proprietary gene delivery vector that has allowed the antisense medicine to be delivered with high efficiency to the nucleus of target cells. This vector has been constructed to deliver the anti-HIV genes to the proper cells and to specifically block the virus without affecting other cell functions. The vector was also designed to be invisible to the body's immune system, so as not to trigger an immune response in the patient.

The preclinical data for this trial were published in the Journal of Virology in May 1997 and showed that Enzo scientists, along with researchers from New York Hospital-Cornell University Medical School, were able to successfully use genetic antisense to produce human immune cells in the laboratory that were resistant to repeated challenges by HIV over a prolonged period.

In this Phase I trial, certain cells from HIV-infected patients will be treated with HGTV43 to determine its safety in humans. The goal of this therapeutic program is to render immune cells resistant to HIV-1 such that they will reproduce without becoming infected with the virus. It is anticipated that these resistant cells will multiply and create a population of HIV-1 resistant white blood cells in the patient's circulation.

The Company said it expects Phase 1 trials to get underway in a few months at the University of California, San Francisco.

Genetic antisense is based on an inserted gene that continually synthesizes the antisense molecule within the cell. This is in contrast to oligo antisense, where the antisense molecule is synthetically manufactured in the laboratory and has to be readministered repeatedly. The antisense approach offers a different attack on the HIV virus than is being addressed by current HIV drugs, such as protease inhibitors, that target the disease by inhibiting certain enzyme activities present in both the virus and in the cell. Genetic antisense is targeted specifically towards the virus and is designed not to affect cell function.

"Enzo's approach represents a promising new therapeutic direction," said Dean L. Engelhardt, Ph.D., Senior Vice President of Enzo "and given the reported rate of resistance which seems to be developing among those individuals using current drug therapies, it could represent a vital new treatment. We believe that because of its specificity in targeting disease and its potential for low toxicity, this form of genetic medicine could become an important new medical tool with broad application."

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.

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CONTACT: Barry Weiner, 212/583-0100 Steve Anreder, 212/421-4020

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