Researchers at the University of California, San Diego (UCSD),announced that they have initiated a Phase I clinical trial of ViageneInc.'s ImmunoTherapeutic HIV gene therapy.The UCSD trial is the first human gene therapy trial for the university'smedical school but the third Phase I trial for Viagene's treatment. Allthe trials are supported by The Green Cross Corp. of Osaka, Japan,which has an equity investment of $4.75 million in Viagene of SanDiego. Green Cross will receive exclusive worldwide marketing rightsto the final product.According to Robert Abbott, the company's president and chiefexecutive officer, all three Phase I trials of Viagene's therapy haveinvolved people who are HIV-positive, all the trials attempt tostimulate the body's cytotoxic or "killer" T lymphocytes (CTLs) torecognize and destroy HIV-infected cells, and they all use the samegene therapy product. The difference is in the way the drug wasadministered.The first trial involved four patients and was done ex vivo. In thesepatients, a skin biopsy was taken and fibroblasts were extracted. Thefibroblasts were then transfected (or modified) in vitro with a murineretroviral vector and injected back into the patients. Patients were giventhree injections over a two-month period. Abbott said two of the foursubjects in this trial showed statistically significant increases in CTLlevels after one course of treatment.The second and third trials, including the one at UCSD, involve directintramuscular injection of the murine retroviral factor. In the secondtrial, however, the patients had a CD4 protein cell count greater than500, Abbott said. In the third, the 20 patients involved have a CD4count in the 200-500 range. (CD4 cell counts are used to measure howfar HIV infection has progressed. The lower the count, the moreprogressive the infection.)The patients in the UCSD trial will receive a series of three treatmentsover three months. They will be followed closely for three years,although the researchers involved expect initial evidence of the safetyand immunological activity of the vaccine to be apparent within six to12 months.

-- TEXT: Philippa Maister

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