VaxGen says data from HIV vaccine trial will be available in March
BY Advocate.com Editors
January 25 2003 12:00 AM ET
Biotech firm VaxGen on Wednesday announced that the company does not yet have complete data from its recently completed Phase III clinical trial of the experimental HIV vaccine AIDSVAX but that the final results are expected to be released by the end of March. The announcement came amid speculation that the trial results were disappointing and that VaxGen might not seek Food and Drug Administration approval of the vaccine.
"A rumor reported on the Internet today indicated that the company's stock had fallen because the Phase III trial had produced unfavorable results," a company press release issued on Wednesday stated. "Once again, no data are available yet to conclude if or how effective the vaccine is."
The HIV vaccine, the first ever to make it to Phase III trials, was studied among 5,100 sexually active gay men. A second Phase III trial involving 2,400 injection-drug users in Thailand will wrap up later this year. AIDSVAX aims to stimulate antibodies to attack HIV in the body and prevent the virus from infecting immune system cells. The FDA has already granted fast-track review status for AIDSVAX.