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January 9, 2003 7:30 a.m. EST |
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| FROM THE ARCHIVES: January 9, 2003 VaxGen CEO: Confidence Will Grow In AIDS Vaccine Data By JOHANNA BENNETT Of DOW JONES NEWSWIRES (This report was originally published late Wednesday.) SAN FRANCISCO -- When VaxGen Inc. (VXGN) releases results for late-stage human trials of its experimental AIDS vaccine later this year, it will be easier to prove the efficacy of the vaccine. Higher infection rates for the AIDS virus and a lower dropout rate among study participants have lowered the bar that results must reach in order for the company to claim with confidence that the vaccine is beneficial, according company officials. "It is good news from a bio-statistical standpoint," said spokesman Lance Ignon in a later interview. The comments by Chief Executive Lance Gordon during the 21st annual J.P. Morgan H&Q Healthcare Conference, come as the Brisbane, Calif., biotechnology company is preparing to release results for the first of two late-stage clinical trials sometime in the next few months. Last month, the U.S. Food and Drug Administration agreed to an accelerated review of the vaccine, known a AIDSVAX, for the prevention of HIV infection. Results from a study - which involves 5,400 people in the U.S., Canada, the Netherlands and Puerto Rico - will be released before the end of March, the company said. Whether the data will be sufficient to win FDA approval for the vaccine remains to be seen. Wall Street investors have been eager for some indication of what efficacy rate the FDA desires, but that has so far been unclear. Four years ago, VaxGen's goal was to determine if the AIDSVAX prevents HIV infection in 60% of patients with a 95% confidence rate. The endpoint was based on lower infection and retention rates from four years ago. Since then, the infection rate for the HIV virus has doubled to 3%. Also, the study retained about 95% of its subjects, 10% more than initially expected. With more people becoming infected and fewer people leaving the study, scientists will have an easier time detecting incidents in which the vaccine benefited patients. But it does not increase the chance that the vaccine will actually work. "It increases the statistical power," Ignon said. "That means better confidence in results. That does not mean we are lowering our expectations. Our expectations remain the same." VaxGen's vaccine is designed differently than most vaccines. Often, vaccines are built using a diluted form of a virus, or a piece of its DNA, to trick the immune system into thinking it is battling the real virus. If a real infection occurs later, the body is protected by antibodies. Rather than taking the risk of injecting people with dead HIV, VaxGen uses a protein isolated from the surface of HIV, which is suppose to eliminate the risk of the vaccine infecting people. A second late-stage clinical trial will be released late this year that studies the effect of the vaccine on subtypes of the HIV prevalent in southeast Asia. -Johanna Bennett; Dow Jones Newswire; (201) 938-5240; johanna.bennett@dowjones.com
Updated January 9, 2003 7:30 a.m. EST |
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