WASHINGTON, D.C. -- Viagene Inc. said Tuesday that the FDA'sVaccine Advisory Committee has approved Phase I trials to testViagene's HIV immunotherapeutic.

The trial, which is to start around the end of the year, will bethe first gene therapeutic-based commercial proposal aimeddirectly at treating HIV infection, the company said.

"There have been other gene therapy trials, but they were notdirected at HIV," said Steve Mento, Viagene's vice president ofresearch and development. "They were directed at cancer."

The privately held San Diego company's procedure consists oftaking cells from a patient and genetically engineering themwith a non-infectious retroviral vector to achieve intracellulardelivery of a gene sequence that codes for certain HIV proteins.The cells are then reinfused into the patient, where they areintended to stimulate a vigorous immune response of cytotoxicT-lymphocytes and antibodies against HIV.

Mento said a minimum of 12 patients will participate, all withHIV and all with CD4-plus counts greater than 500. CD4-pluslymphocytes assist in antibody production.

Chosen for the study will be patients in early stages of HIVinfection who do not exhibit symptoms associated with AIDS,such as Kaposi's sarcoma or hairy leukoplakia. "They will alllook like healthy individuals," Mento said. He said the site forthe trial would be somewhere in Southern California. Mentosaid initial results could be expected from between six monthsto one year after the trial starts.

"It's an important milestone for Viagene," Mento said. "It'sespecially significant that the FDA committee supported thefact that it is appropriate to test gene therapy as commercialproducts."

-- Steve Payne BioWorld Staff

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