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

To: Tom Hua who wrote (1234)	3/9/2000 3:22:00 PM
From: tonyt	Respond to of 1972

Vical Off 28% Following Washington Post Article Dow Jones Newswires By Beth M. Mantz NEW YORK -- Vical Inc.'s (VICL) shares fell 13% Thursday morning after a Washington Post article recounted the death of one of Vical's late-stage, phase III trial participants and reported that one of the trial centers decided to put enrollment in the trial on hold. Shares of Vical were recently down 7 7/16 to 49 5/8, on volume of 1.6 million shares, compared with average daily volume of 380,200. But considering that the Food and Drug Administration and other safety panels have not censured Vical or requested changes in the study testing Vical's gene therapy Allovectin-7, as well as the continued testing and enrollment of phase III study in metastatic melanoma, Robertson Stephens & Co. analyst Lesley Wright Marino is not concerned about the San Diego company. "Patients with life-threatening cases of cancer unfortunately die," she said, adding that the news is old and has been dealt with and the reaction is "a little over the top." Vical officials were not immediately available to comment. Allovectin is designed to be injected directly into a tumor, where malignant cells absorb the therapy and elicit antigens. According to the American Cancer Society, about 480,000 Americans suffer from malignant melanoma, a form of skin cancer. As reported in the Washington Post Thursday, in early September one of the trial participants at the University of Arkansas died. Laura Hutchins, the principal investigator at the center, initially declared the death unrelated to the treatment. An autopsy, however, found an accumulation of ascites - a fluid in the abdomen of the deceased. As reported by the Washington Post, the autopsy proposed that this fluid buildup might have been caused by the new genes and contributed to the death. In accordance with protocol governing serious adverse events, the death was reported to the Food and Drug Administration, Marino said. In choosing whether to classify the event as "unlikely," "possibly or probably," or "certainly" related to the treatment, Hutchins, the investigator, classified the death as "possibly or probably related to the event" in light of the autopsy result, Marino said. Robertson Stevens' Marino said that after the death was reported and classified, "it appears the FDA, RAC (recombinant DNA advisory panel of experts that consults the FDA and reviews all gene therapy experiments), Independent Drug Safety Review board and the (University of Arkansas) center's IRB were completely comfortable that the underlying disease, not the study drug, led to the patient's death." Months after the death, a trial center in Florida heard about the event. That center's hospital administrator, not the researcher, decided to halt enrollment last week until there was further information about the event, said Marino, who expects Vical to provide that data. "Once the center reviews, it will probably start enrollment," said Marino, adding that the University of Arkansas center hadn't halted the study but continued it. Additionally, the FDA hasn't asked Vical to change its protocol, or pull the study. Recently, RAC met for its periodic review of adverse gene-therapy events that occurred in the previous quarter. The panel reviewed the death in the Vical study, and then moved on, according to Marino. "My understanding - since I wasn't there - (the event) was not made into a big deal, and didn't warrant undue additional discussion." Vical officials weren't immediately available for comment. -Beth M. Mantz; Dow Jones Newswires; 201-938-5393

To: Tom Hua who wrote (1234)	3/9/2000 9:37:00 PM
From: David Bogdanoff	Respond to of 1972

Tom; This single adverse event in which the gene treatment is "possibly or probably" related to the patient's death, while clearly unfavorable, is neither a company killer nor a treatment killer, IMHO. All treatments carry some adverse risk, and the safety profile is assessed in light of the seriousness of the disease. David

To: Tom Hua who wrote (1234)	3/10/2000 10:29:00 AM
From: Jim Roof	Read Replies (1) \| Respond to of 1972

Tom, Some day you will look back at this 'stock killer' story and see that not only was it a poorly researched media hype piece but that it provided a wonderful opportunity to get into VICL. VICL will recover when it is finally figured out that this is a gross overreaction to what is, in medical terms, the cost of doing business. In fact, I am certain that there will be more unexplained deaths that an honest researcher cannot totally rule out the therapy as a contributing factor (as was true in this case) but consider the near extremely high death rate of melanoma and the very high death rate associated with other treatments. Then tell me that ONE unexplained death in 400 patients tested kills this company and its technology. If you sold yesterday then I at least hope you waited until the afternoon.