VaxGen Inc announced that the U.S. Food and Drug Administration (FDA) has designated HIV/AIDS vaccine candidates, AIDSVAX B/B and AIDSVAX B/E, Fast Track Products for the prevention of HIV infection. The Fast Track designation will enable rapid regulatory review of AIDSVAX.

AIDSVAX B/B and AIDSVAX B/E are the only preventive AIDS vaccine candidates to advance to Phase III clinical trials. AIDSVAX B/B is being tested in a randomized, double-blind, placebo-controlled study of 5,400 people in the United States, Canada, the Netherlands and Puerto Rico. Primary results from the trial are expected to be announced in the first quarter of 2003.

VaxGen is also nearing completion of its Phase III trial of AIDSVAX B/E in Thailand. AIDSVAX B/E is designed to protect against HIV subtypes B and E, and the company expects to announce primary results of that trial in the second half of 2003. Subtype E is prevalent in Southeast Asia and the Central African Republic.

"Every day thousands of people become infected with HIV," said VaxGen President Donald P. Francis. "Designation of both AIDSVAX B/B and AIDSVAX B/E as Fast Track Products recognizes the severity of the pandemic and the unmet need for a vaccine to prevent new infections."

Under the FDA Modernization Act of 1997, the Fast Track Program of the FDA is designed to expedite the review of a new drug that is intended for the treatment (or prevention) of a serious or life-threatening condition, and demonstrates the potential of a drug candidate to address unmet medical needs for such a condition.

AIDSVAX, made through recombinant DNA technology, contains recombinant gp120 (rgp120) proteins identical to those on the surface of HIV. The rgp120 in AIDSVAX B/B is identical to those found in two strains of HIV subtype B (prevalent in North America, Europe, Australia, Japan and Puerto Rico) while the rgp120 in AIDSVAX B/E is identical to proteins found in HIV subtypes B and E. These proteins induce the immune system to make antibodies and VaxGen's clinical trials are designed to evaluate how well these antibodies prevent HIV infection.

AIDSVAX cannot cause HIV infection since it contains no genetic material from the virus. In each of the seven safety reviews conducted by an independent data and safety monitoring board that oversaw the trials of AIDSVAX, the vaccine candidates were found to have a strong safety profile. More than 32,000 injections have been administered since human testing first began.

Additionally, VaxGen is in the early stages of developing a vaccine against HIV subtype C, prevalent in South Africa, India and China.