BUSINESS WIRE; Wednesday, June 3, 1998
The company also is preparing to conduct Phase III clinical trials in Thailand and anticipates receiving the go-ahead from official agencies, including the FDA and Thai Health Ministry, to begin inoculating volunteers there this fall.
In its trials in North America and Thailand, the company will be testing formulations of AIDSVAX that are designed to protect against strains of HIV-1 in the Americas, Western Europe, Australia and Southern Asia, where more than 3 billion people remain at risk from these strains of HIV. At the same time, the company said, it will be investing in research to develop formulations of its vaccine that will protect against major strains typical of the strains of HIV-1 viruses in China, India and Africa.
"Our primary goal at VaxGen is to develop a vaccine that can be used around the world and help put an end to an epidemic that already has caused untold suffering and taken more than 12 million lives," said Dr. Donald P. Francis, President of VaxGen. "We are excited and, at the same time, humbled by the distinction of being the first to reach this point in what is one of the most vital public health battles facing the world today."
VaxGen presented its initial proposal to an FDA advisory committee in June 1997; it submitted its final protocol for the Phase III trials to the FDA and received that agency's permission last month to proceed in the United States with the large-scale trial, which will involve approximately 5,000 volunteers at multiple sites in North America. Phase III trials are designed to study the safety and efficacy of an experimental vaccine or drug and, if successful, are a critical step in the clinical testing process that precedes an application to the FDA for approval to license and market the product.
"With Phase III trials of AIDSVAX we are marking a new era in the AIDS crisis," said Dr. Robert C. Nowinski, Chairman of VaxGen. "After 17 long years of struggle in learning about this disease and how to treat it, we are finally moving toward a time when we can look to preventing AIDS."
Dr. Seth Berkley, president of the International AIDS Vaccine Initiative (IAVI), a nonprofit organization that seeks to accelerate the development of safe and accessible AIDS vaccines, said: "This is a watershed event in the AIDS crisis.
"With 30 million people around the world already infected with HIV, and more than 16,000 new infections each day, it is crucial that we move toward the creation of better prevention technologies -- those that have the potential to end the epidemic, not just to mitigate its consequences," Dr. Berkley continued. "To achieve this goal, it is likely that we will need multiple vaccine efficacy trials, in both industrialized and developing nations. IAVI is pleased to see this process beginning."
Initially, clinics in several cities, including Chicago, Denver, Los Angeles, Philadelphia and St. Louis will begin inoculating volunteers with AIDSVAX this month. The Phase III trials will expand to an additional 10 clinics within two to three months, and to a total of 30 to 40 clinics in North America by year-end. The formulation of AIDSVAX to be used at these sites is designed to protect individuals from strains of HIV typical of the majority of AIDS-causing viruses in the Americas, Western Europe and Australia.
The Phase III clinical trials of AIDSVAX in Thailand will be regulated by the Thai Health Ministry and will involve approximately 2,500 volunteers at 16 clinics. The formulation of AIDSVAX to be tested in Thailand is designed to protect against strains of HIV typical of AIDS-causing viruses in Thailand, Korea, Japan, Taiwan and Indonesia.
The Phase III trials are designed for a three-year study period, with a one-year recruitment period.
The current "bivalent" formulations of AIDSVAX, so called because they are developed from recombinant forms of two strains of HIV, are the successor vaccines to a monovalent (one strain) vaccine developed during 14 years of research at Genentech, Inc. and VaxGen. The monovalent vaccine was tested in more than 1,200 human volunteers and was shown to be safe and to induce antibodies against HIV in 99.5% of vaccinated individuals, while producing no significant side effects.
Phase I/II clinical trials of the bivalent forms of AIDSVAX have demonstrated that the second-generation, bivalent vaccines, like the earlier monovalent vaccine, are safe for use in humans and induce a strong immune response. Additionally, the bivalent vaccines induce a greater immune response in animals to a broader range of strains of the HIV virus than did the monovalent vaccine. The Phase III trials of AIDSVAX are designed to determine to what extent the antibodies produced by inoculation will protect against HIV infection.
"We believe the success we have met at every stage of development of AIDSVAX validates VaxGen's commitment and the scientific path it has chosen to follow," said Dr. Francis, a noted epidemiologist and virologist who, with Dr. Nowinski, co-founded VaxGen in partnership with Genentech.
AIDSVAX is a preparation of recombinant gp120 (rgp120), the glycoprotein from HIV's envelope that binds to the surface of T-cells. Injecting rgp120 into the body stimulates the production of antibodies that, in any future exposure to HIV, would hopefully prevent infection.
Research on AIDSVAX began in 1984 by a research team at Genentech that included Dr. Phillip W. Berman, who now is VaxGen's Vice President of Research. In laboratory studies in 1985, this early vaccine was shown to produce neutralizing immunity to the laboratory strain of HIV. In 1990, studies by the Genentech team showed the vaccine protected chimpanzees against an intravenous challenge of live HIV.
Beginning in March 1992, this monovalent vaccine was tested in Phase I clinical trials, in cooperation with the U.S. National Institutes of Health. After those trials demonstrated the vaccine was safe for use in humans, it was moved into Phase II trials that demonstrated that the vaccine produced antibody responses in humans.
In 1995, Drs. Francis and Nowinski, a Seattle-based retrovirologist and entrepreneur, led the spin-off of the Genentech HIV vaccine effort, forming VaxGen to concentrate on further development of AIDSVAX.
The VaxGen team then developed the bivalent form of AIDSVAX to increase the vaccine's potential to protect against additional strains of HIV. Genentech, VaxGen's manufacturing and development partner for the vaccine, has manufactured large quantities of the bivalent AIDSVAX for the upcoming Phase III clinical trials.
"We are proud of the role Genentech played in the development of this vaccine. We congratulate VaxGen's team and support them as they continue this vital work," said William D. Young, Chief Operating Officer of Genentech and a member of VaxGen's board of directors.
VaxGen, based in South San Francisco, Calif., is a biotechnology company committed to making an HIV vaccine for worldwise use. Genentech, one of the world's leading pharmaceutical biotechnology companies, is also based in South San Francisco and is VaxGen's largest shareholder.
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