FDA Agrees To Accelerated Review of VaxGen AIDSVAX HIV Vaccine Currently in Phase III Testing; Company Shares Rise 21%

Brisbane, Calif.-based VaxGen, which will finish two clinical trials on its HIV vaccine AIDSVAX before the end of the year, yesterday announced that the FDA has granted fast-track designation for the experimental vaccine, Reuters/Los Angeles Times reports (Reuters/Los Angeles Times, 12/17). VaxGen, which will finish one clinical trial in the United States on men who have sex with men and one in Thailand on injection drug users, has worked since 1995 to develop vaccines against the subtypes of HIV most common in Asia, North America and Europe. The firm recruited 7,900 volunteers whose "risky behaviors" make them susceptible to contracting HIV and each participant was inoculated with either a placebo or the vaccine. At the end of the year, the company will examine the data and compare the rates of infection in the vaccinated and placebo groups. The company will take three weeks to three months to finish its calculations early next year (Kaiser Daily HIV/AIDS Report, 12/10). According to Jim Key, a spokesperson for VaxGen, "The fast-track designation allows us to file a rolling application with the FDA. ... Once we have the data, we can seek a six-month priority review." The FDA's fast track program accelerates the review process for drugs intended to treat or prevent serious or life-threatening diseases. Under the program, the FDA must notify the company of the acceptance of the marketing application within 45 days of filing and must take regulatory action within six months, compared to one or two years for normal applications. Following the announcement, VaxGen shares rose $2.72 to $15.73, or 21%, reaching a high of $16.60 during the trading session. The company's shares have more than quadrupled since July, when the company announced that its vaccine could be available by 2005 if the trial results were successful (Reuters/Los Angeles Times, 12/17).