Tuesday, Nov 27, 1990

Study Begins to Test gp120 as a Potential Immune System Booster in HIV Infection

South San Francisco, Calif. -- November 27, 1990 --

Genentech, Inc. announced that a human pilot study began last week at Walter Reed Army Institute of Research in Washington, D.C. to test a recombinant vaccine candidate, gp120, as a potential treatment for infection with the human immunodeficiency virus (HIV).

The small pilot study is being conducted to determine if post-exposure immunization with recombinant gp120 can significantly boost the immune system of persons infected with HIV. The gp120 being studied is a recombinant form of gp120, which is an exact copy, made through biotechnology, of a major protein on the surface of the virus that causes AIDS. This is the first human study to test the gp120 candidate vaccine as a potential immune system booster in HIV positive patients.

The pilot studies are designed to determine safety and whether the vaccine will enhance immunity. Antibody and cellular immune response in patients receiving recombinant gp120 will be compared with their own baseline, as well as with a control group. It is the first step in determining if a vaccine can sufficiently boost the immune response in otherwise healthy HIV positive patients enough to extend the latency period of the disease and delay the onset of illness.

"Immunotherapy is an intriguing treatment possibility," said Arthur J. Ammann, M.D., director of clinical research. "Since the immune system of an infected individual is able to fight the virus during a long latency period, a vaccine may be able to boost the body's immune system and further delay illness," he said. "This study is the beginning of what could be a very long process with an outcome that is uncertain."

The initial work will involve 55 volunteer patients and will last about 10 months. The principal investigator is Lt. Col. Robert R. Redfield, M.D., chief of the Department of Retroviral Research at Walter Reed. Walter Reed is one of the most distinguished research centers in viral diseases and has extensive experience in vaccine development, including the potential use of AIDS vaccines as immunotherapeutics.

In a paper published in the scientific journal Nature on June 14, Genentech scientists reported that inoculation with recombinant gp120 had protected two chimpanzees from infection with the HIV virus, the first report published in a scientific journal of animals being protected with a subunit vaccine. A subunit vaccine is a fragment of the HIV virus that is capable of producing protective immunity. The success in protecting the chimpanzees led Genentech to begin work in humans with recombinant gp120.

Genentech is currently evaluating the possibility of a separate human pilot study to test recombinant gp120 as a potential vaccine to protect uninfected individuals against HIV infection.

Genentech, Inc. is a leading biotechnology company focusing on the development, manufacture and marketing of pharmaceuticals produced by recombinant DNA technology.

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