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Biotech / Medical : VICL (Vical Labs) -- Ignore unavailable to you. Want to Upgrade?

To: William Strop who wrote (1232)	3/9/2000 10:18:00 AM
From: tonyt	Read Replies (1) \| Respond to of 1972

"2 Gene Therapy Studies Halted" Exerpt that cites Vical: "The Florida experiment, sponsored by San Diego-based Vical Inc., involves a product called Allovectin-7, a substance made of DNA and fat molecules that helps direct a patient's immune system to tumor cells. It is being tested on patients with an advanced form of skin cancer, called melanoma, or with persistent or recurrent tumors of the head and neck. The death occurred in early September at the University of Arkansas, one of several sites for the Vical study. The principal investigator there, Laura Hutchins, initially declared the death unrelated to the treatment, said Alan Engbring, director of investor relations for Vical.<p> But an autopsy report, which took several months to get to Hutchins, concluded that the patient's melanoma was not completely responsible for the death. It said one possibility was that a buildup of fluids in the patient's abdomen that had occurred during the treatment might have been caused by the new genes and contributed to the death. That finding led Hutchins to reclassify the death last month as "probably" related to the treatment, the only option between "unlikely" and "definitely" on Vical's report forms. In response, a safety committee at the University of South Florida--another site for the study--shut down the trial late last month. "This is a single center that in our opinion has overreacted," Engbring said, noting that none of the other sites has halted enrollment. "I do think we have a treatment that can help a lot of people." Engbring said he has no explanation for why the autopsy report did not reach Hutchins until January. He said the delay had nothing to do with the December issuance of new stock that raised $117 million for the company. A Dec. 21 Vical news release announced that a company-supported data safety review board (which Engbring said had seen the autopsy report) "found no safety issues to date" in the company's Allovectin experiments. Richard Heller, chairman of the University of South Florida's biosafety committee, which suspended the campus's part in the study, said the committee's action was prudent in the light of recent revelations about scientific and ethical lapses in the gene therapy field. "Everybody felt that with the atmosphere right now, we don't want to take any chances." Vical recently submitted additional information, Heller said, and the committee will consider reopening the study at its March meeting." For full story see: washingtonpost.com