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HUMAN CLINICAL TRIALS OF VIAGENE'S GENE TRANSFER THERAPEUTIC FOR AIDS CLEARED BY FDA ADVISORY COMMITTEE

 HUMAN CLINICAL TRIALS OF VIAGENE'S GENE TRANSFER THERAPEUTIC
 FOR AIDS CLEARED BY FDA ADVISORY COMMITTEE
 WASHINGTON, June 16 /PRNewswire/ -- At a public meeting, the Food and Drug Administration's Vaccines Advisory Committee today unanimously recommended that the FDA allow Viagene, Inc. to proceed with human clinical testing of its HIV immunotherapeutic. This is the first gene transfer-based therapeutic to be reviewed by an FDA advisory committee. This is also the first gene therapeutic-based commercial proposal aimed directly at treating HIV infection.
 "This is a major step forward in the commercialization of products based on gene transfer technology," said Steve Mento, Ph.D., vice president of research and development. "Viagene is elated to be the first company to achieve this important milestone."
 Viagene's therapeutic consists of cells taken from a patient and genetically engineered with a non-infectious retroviral vector to achieve intracellular delivery of a gene sequence that code for certain HIV proteins. The readministration of these cells is intended to lead to a vigorous immune response of cylotoxic T-lymphocytes and antibodies against HIV. Pending final FDA clearance, Viagene expects to manufacture patient specific products shortly and to begin clinical testing by year end.
 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 infections, cancers and other diseases.
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 /CONTACT: Anthony J. Russo or Kathryn Comba of Noonan/Russo Communications, 212-979-9180, for Viagene/ CO: Viagene, Inc. ST: California IN: MTC SU:


SM-OS -- NY078 -- 0875 06/16/92 17:48 EDT
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Publication:PR Newswire
Date:Jun 16, 1992
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