AEGiS-PRn: Gene Therapy for HIV to Get First Test in Humans; Enzo Therapeutics Files IND with FDA for Testing at University of California, San Francisco

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

Gene Therapy for HIV to Get First Test in Humans; Enzo Therapeutics Files IND with FDA for Testing at University of California, San Francisco

PR Newswire; Thursday December 18, 9:18 am EST

FARMINGDALE, N.Y., Dec. 18 /PRNewswire/ -- Enzo Biochem (Amex: ENZ - news) announced today that its wholly owned subsidiary, Enzo Therapeutics, filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate clinical testing, for the first time, of Enzo's new form of gene therapy designed to stop the progression of virus in HIV-infected individuals.

The clinical trial will be done at the University of California, San Francisco (UCSF), where Morton J. Cowan, MD, a noted expert in the management of immune compromised patients, and Marcus A. Conant, MD, a leading physician in the management of HIV-1 infected patients, will be the principal investigators. This Phase I trial is intended to evaluate the safety of Enzo's genetic therapy in patients infected with HIV-1.

In the May edition of the Journal of Virology, Enzo researchers and their collaborators reported success using the Enzo's genetic therapy approach to protect human cells from the AIDS virus in vitro. It was shown that the presence of the anti-viral genes in human immune (CD4+) cells resulted in resistance to repeated attacks by HIV over a prolonged period.

A key element that led to the success of this approach was the development by Enzo scientists of the StealthVector(TM), a gene delivery system which localizes primarily in the cell nucleus where it could be most effective in inhibiting viral growth. The vector was also designed to be "invisible" to the human immune system, so as not to trigger an immune response in the patient.

"This is an innovative, exciting approach that may give us new options for people infected with HIV," said Dr. Conant, a former Director of the UCSF AIDS Research Institute who built the largest private AIDS practice in the country. "Initially this treatment will be important for two populations: those who have been infected for many years and treated with sequential antivirals who have developed class resistance, and those who cannot comply with medication regimens for a variety of reasons."

"We are looking forward to the evaluation of the safety and efficacy of our especially 'nondisruptive' type of gene delivery system," said Dr. Dean Engelhardt, Senior Vice President of Enzo. "We view this technology as a potentially important tool with broad applicability. Our new StealthVector could serve as the platform for the delivery of any number of genes with therapeutic efficacy."

In the UCSF trial, HIV-infected patients will undergo leukapheresis, a process in which blood cells, including immune cells and stem cells, are removed from the body. The stem cells, after treatment with the StealthVector, are reintroduced into the patient, where they are expected to engraft and produce a population of immune cells resistant to HIV infection. Patients will be followed to see whether their overall T-Cell count has increased, how they respond, and how the progression of HIV has been affected.

Enzo Biochem is engaged in the research, development and manufacture of innovative health care products based on molecular biology and genetic engineering, and in providing diagnostic services to the medical community.

SOURCE: Enzo Biochem

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