BUSINESS WIRE; Wednesday July 1, 8:01 pm EST
Earlier this month, the Food and Drug Administration authorized VaxGen to go ahead with this large-scale prevention study, involving approximately 5,000 subjects at multiple sites in the United States. This is the first Phase III trial permitted by the FDA for a vaccine to prevent infection with HIV, the virus that causes AIDS.
The bivalent vaccine developed by VaxGen uses recombinant glycoprotein 120 (gp120) from two different HIV strains to stimulate production of antibodies to the HIV virus.
Specialty Laboratories will serve as the central laboratory to screen volunteers at risk of becoming infected with HIV and monitor the 5,000 participants selected for the three-year trial. "Specialty is indeed proud to take part in VaxGen's study, which represents a giant step toward controlling a disease that has already taken far too large a toll in human life and human suffering," commented Specialty Laboratories' chairman, James B. Peter, M.D., Ph.D.
Specialty Laboratories has been in the forefront of clinical testing for HIV for more than a decade. In 1988, Specialty introduced the first commercial HIV DNA testing by polymerase chain reaction (PCR). Recently, Specialty's Research and Development Team improved the PCR testing, creating an ultrasensitive test to monitor HIV viral load.
Specialty also developed the first genotyping assay (HIV-GenotypR) to detect resistance to specific HIV drug therapies. In addition, Specialty has developed assays to quantify all FDA-approved antiretroviral drugs used for HIV-1 therapy.
VaxGen, based in South San Francisco, is a biotechnology company committed to making an HIV vaccine for worldwide use. Genentech, one of the world's leading pharmaceutical biotechnology companies, is VaxGen's largest shareholder.
Specialty Laboratories, a privately held clinical reference laboratory founded in 1977, is a full-service, clinical reference laboratory serving clients throughout the United States; Specialty's international division has laboratory centers located on three continents.
Contact: Specialty Laboratories, Santa Monica Hun-Chi Lin, 800/944-7271, ext. 2292 hlin@specialtylabs.com (e-mail) http://www.specialtylabs.com (Web site)
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