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Biotech / Medical : Biotech Short Candidates -- Ignore unavailable to you. Want to Upgrade?

To: Icebrg who wrote (296)	1/8/2003 4:16:32 PM
From: tuck	Read Replies (1) \| Respond to of 897

Dang, slept late this morning and missed my shot at AGEN. It appears to be off on sympathy with Vaxgen (licensed its gp120 vaccine to VaxGen) or maybe just the market as a whole. This afternoon, we have this on the subject of that vaccine: >>SAN FRANCISCO, Jan 8 (Reuters) - VaxGen Inc. (NasdaqNM:VXGN - News) on Wednesday downplayed expectations for upcoming results from a pivotal-stage trial of its experimental AIDS vaccine. Confidence in the data has been compromised by the fact that more patients than expected have stayed in the study -- meaning the total number of trial participants has increased -- at a time when transmission rates for the virus have doubled, VaXGen Chief Executive Lance Gordon said at a J.P. Morgan health-care conference here. "Without those changes in the statistics, the confidence in the data would have been higher and the easier it would be to get through the regulatory pathway," he said. The CEO said the U.S. Food and Drug Administration has agreed that the study design fits regulatory review needs -- but the data will drive the agency's decision. Last month, the FDA agreed to an accelerated review of the AIDSVAX vaccine for prevention of HIV infection. Results from a pivotal-stage trial in 5,400 people in the United States, Canada, the Netherlands and Puerto Rico will be announced within the next couple of months, the company said. The goal of the trial is prevention of HIV infection in 60 percent of patients, but investigators will also be looking at the vaccine's impact on slowing viral replication in patients who do become infected. VaxGen, based in Brisbane, California, has said in the past that regulatory approval could hinge on whether the trial shows a 30-percent efficacy level, but Gordon pulled away from that target on Wednesday. "I wish that number had never been talked about .... Thirty percent would have been the lower end of a 95-percent confidence level four years ago," the CEO said. Since then, he said, about 10 percent more patients than expected have remained in the trial and, outside of the trial, the transmission rate for AIDS has risen from about 1.5 percent to 3 percent. Because those statistics are used in calculating the vaccine study's statistical significance, they will influence the trial outcome, VaxGen said. The vaccine is designed to work by inducing the immune system to produce antibodies that attach to a protein on the surface of the virus. The theory is that by preventing the virus from attaching to cells it will stop infection, but making a vaccine against HIV is difficult because the virus integrates itself into cells, and because it attacks the very immune cells that are normally stimulated by a vaccine. At the end of the day, VaxGen said, the FDA will base its decision on the benefits of the vaccine versus its risks, and so far it has not been shown to raise risk. If the trial shows that the vaccine is effective in 20 percent of patients, "we could certainly proceed" with an FDA application, Gordon said. Another pivotal-stage trial of a vaccine version designed to fight HIV subtypes prevalent in Southeast Asia is being conducted in Thailand, and those results are expected in the second half of next year.<< snip Cheers, Tuck