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 SAN DIEGO, Aug. 11 /PRNewswire/ -- Viagene, Inc. today announced that treatment of patients has commenced in its human gene therapy Phase I Clinical Study to treat malignant melanoma. This study is the first to investigate lymphokine gene therapy as a means to boost presentation of tumor cell antigens to the immune system. This study is also the first gene therapy use of gamma interferon, which Viagene recently licensed from Genentech, Inc.
 The principal investigator responsible for conducting the melanoma study is Hilliard F. Seigler, M.D., professor of surgery and immunology of the Duke University Medical Center in Durham, N.C., and an internationally recognized expert in tumor vaccine research.
 Malignant melanoma is a potentially fatal form of skin cancer that afflicts more than 32,000 people in the United States each year. According to Viagene's Phase I Study protocol, tumor cells are removed from patients and modified using Viagene's gene transfer product, or vector. The vector inserts into the tumor cells the gene for human gamma interferon, an important immune system activation protein. These modified tumor cells are then used in a series of injections as a tumor vaccine in order to enhance the patient's immune response against their unmodified, metastatic tumor cells. The Phase I study will involve 20 patients. "By stimulating the patient's own immune system to recognize tumor cells more effectively, we are in essence therapeutically vaccinating the patient against the cancer," said Dr. Seigler.
 This Phase I Clinical Study was reviewed and approved in June by the Recombinant DNA Advisory Committee of the National Institute of Health. An Investigational New Drug Application was also submitted to and reviewed by the U.S. Food and Drug Administration.
 "Viagene is very pleased to be collaborating with Dr. Seigler, who has administered over 40,000 tumor vaccine injections to patients. We believe that the addition of gene therapy technology to his extensive vaccination program will be a major step forward in developing an effective treatment for metastatic melanoma," said Robert T. Abbott, Ph.D., president and CEO of Viagene, Inc.
 Earlier this year, Viagene signed a licensing agreement with Genentech, Inc. of South San Francisco for the gene therapy use of gamma interferon. "Melanoma is the first cancer we will attempt to treat using this gamma interferon gene transfer product. We also intend to study other cancers where immune stimulation may be an important treatment approach," said Dr. Abbott.
 Viagene, Inc. is a private biopharmaceutical company located in San Diego that is pursuing the discovery, development and manufacture of gene-based therapeutics for the treatment of viral diseases, cancers and genetic disorders.
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 /CONTACT: Robert T. Abbott, Ph.D., MBA, president and CEO, of Viagene, 619-452-1288, or Anthony J. Russo, Ph.D., of Noonan/Russo Communications, 212-696-4455/

CO: Viagene, Inc. ST: California IN: MTC SU:

MP-LG -- NY022 -- 1547 08/11/93 09:39 EDT
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Publication:PR Newswire
Date:Aug 11, 1993

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