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VIAGENE FILES WITH FDA TO BEGIN CLINICAL TRIAL OF HIV PRODUCT

 VIAGENE FILES WITH FDA TO BEGIN CLINICAL TRIAL OF HIV PRODUCT
 SAN DIEGO, April 23 /PRNewswire/ -- Viagene, Inc. today announced that to filed a commercial Investigational New Drug (IND) application with the Food and Drug Administration to begin human clinical trials of its IIIV ImmunoTherapeutic to treat individuals infected with the human immunodeficiency virus (HIV). The company's HIV ImmunoTherapeutic, which is being developed under an agreement with the Green Cross Corporation (NIKKEI - 4522) of Osaka, Japan, employs the company's proprietary gene transfer technology and is designed to destroy HIV infected cells through stimulation of the body's immune system killer T- cells. HIV is the causative agent of AIDS in humans.
 The company-sponsored IND proposes to conduct Phase I clinical trials in pre-AIDS, IIIV infected patients. Viagene's IIIV ImmunoTherapeutic uses a genetically engineered, non-human virus to deliver into cells a gene sequence that codes for the production of IIIV antigens. By producing HIV antigens intracellularly, the drug is designed to stimulate a patient's immune system to mount a cytotoxic T-lymphocyte (CTL), or killer T-cell, response directed against HIV infected cells. In preclinical mouse and primate studies, Viagene's HIV ImmunoTherapeutic stimulated high levels of HIV-specific CTLs without producing toxic or other adverse side effects.
 "Filing this IND represents achievement of a significant milestone in the development of our lead product, a drug that may have the potential to benefit HIV infected individuals," said Robert T. Abbott, Ph.D., president and CEO of Viagene. "This also represents the first step toward commercialization of Viagene's proprietary gene transfer technology."
 Subject to FDA clearance, Viagene plans to begin Phase I clinical trials during the third quarter of 1992. The company intends to use an "ex vivo" approach and has begun to identify patients for these clinical trials since the approach will require preparation of patient-specific products. An ex vivo approach involves removing cells from each patient, growing the cells in culture and treating these cells outside the body with Viagene's product. This process of preparing patient- specific products is expected to take approximately four months. During this time, the FDA will review the company's IND and will ask the Vaccine Advisory committee to address specific issues identified by the FDA.
 The company's HIV ImmunoTherapeutic is being developed under an agreement entered into in April 1991 with the Green Cross Corporation. In return for worldwide marketing rights, Green Cross agreed to provide Viagene with a combination of research funding, equity investment and certain milestone payments expected to approximate $40 million over the four-year term of the agreement. As a result of filing the IND, Viagene has earned its first milestone payment which it expects to receive within sixty days. Viagene has retained worldwide exclusive right to manufacture all HIV ImmunoTherapeutics produced under the Green Cross agreement and will receive royalties on sales of product.
 Viagene is a private biopharmaceutical company located in San Diego, that is pursuing the discovery, development, and manufacture of gene transfer drugs for the treatment of severe viral infection, cancers and other diseases.
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 /CONTACT: Robert T, Abbott, president and CEO of Viagene, 619-452-1288, or Anthony J. Russo of Noonan Russo, 212-979-9180, for Viagene/ CO: Viagene Inc. ST: California IN: MTC SU:


AH-SM -- NY045 -- 1812 04/23/92 11:14 EDT
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Date:Apr 23, 1992
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