Company Profile
Company Highlights:
- The only company with preventive HIV/AIDS vaccines in Phase III clinical trials
- Two separate trials underway with nearly 8,000 volunteers participating on three continents
- Vaccines appear safe and induce immune response in all subjects
- Interim efficacy analysis scheduled for November 2001
- 4- to 5-year competitive lead
Company Profile:
VaxGen is the worldwide leader in developing preventive vaccines to eradicate HIV/AIDS. Headed by a distinguished team of research scientists and business professionals, we are the only company with vaccines in Phase III clinical trials, the final stage before regulatory approval.
We are conducting two separate clinical trials, one in North America and Europe and another in Bangkok, Thailand. The trials involve nearly 8,000 volunteers and are designed to determine how well our vaccine, AIDSVAX®, prevents HIV infection.
The vaccine being tested in North America/Europe is designed to combat HIV subtypes found in the U.S., Canada, Europe, South America, the Caribbean, Australia and New Zealand. The vaccine formulation being tested in Thailand is designed to combat the HIV subtypes found in Southeast Asia and the Western Pacific Rim. Meanwhile, our research and development department is preparing a vaccine formulation for a subtype that affects Africa, India and China.
Every six months an independent Data and Safety Monitoring Board (DSMB) examines our trials for safety and conduct. The trials already have completed four successful safety reviews. In the fall of 2001, the DSMB will unblind the data from the North American/European trial and, for the first time, examine how well the vaccine is preventing HIV infection. If there is enough statistical evidence to show that AIDSVAX is effective, we expect to halt the trial and begin the process of applying for regulatory approval. If the analysis is statistically inconclusive, the trial will proceed to its scheduled end-point 12 months later, in the fall of 2002, when additional statistical information will be available.
VaxGen was formed in 1995 by a spin-off of vaccine technology from Genentech, Inc., one of the world’s largest biotech companies. VaxGen is located in Brisbane, California, and its common stock is traded on The Nasdaq Stock Market® under the symbol VXGN.
