Biotech Firm GeoVax Labs Seeking FDA Approval To Launch Phase II Trials Of HIV Vaccine Candidate

Main Category: HIV / AIDS
Also Included In: Immune System / Vaccines
Article Date: 10 Jul 2008 - 12:00 PDT

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The Atlanta-based biotechnology firm GeoVax Labs on Tuesday announced that it is seeking FDA approval to launch Phase II clinical trials of its experimental HIV vaccine this fall, the Atlanta Journal-Constitution reports (Hendrick, Atlanta Journal-Constitution, 7/9).

GeoVax is developing the experimental HIV vaccine in collaboration with Emory University, CDC and NIH. According to Emory officials, a prototype of the vaccine provided long-term protection against development of AIDS in nonhuman primate studies conducted more than three years ago at the Yerkes National Primate Research Center in Atlanta (Kaiser Daily HIV/AIDS Report, 5/8). According to Robert McNally, president and CEO of GeoVax, during one study that involved two monkeys given a simian version of the experimental vaccine, conventional therapy was stopped after six weeks and the vaccine "kept the viral load in check." He added that there "was a 100-times reduction in the viral load on one animal and a thousand-times reduction in the second animal. ... This is significant because it is suppressing AIDS in monkeys, and that's what we are trying to do in people." McNally noted that the "vaccine controlled the infection even in the absence of drugs." Based on those results, GeoVax started "planning for a therapeutic trial in infected and drug-treated humans," McNally said. He added, "The intent of therapeutic vaccination is for the vaccine to control HIV virus levels in infected individuals to very low levels, thus blocking the development of AIDS."

According to the Journal-Constitution, the proposed trial -- which will be conducted by NIH and supported by the HIV Vaccine Trials Network -- will involve 225 "healthy volunteers" from the U.S. and South America. McNally said the purpose of the study is to "further evaluate the safety and immunogenicity" of the vaccine candidate. He added that the company's goal is to have a therapeutic vaccine approved by FDA that would reduce the amount of antiretrovirals needed by people living with HIV to control its spread and the development of AIDS.

Harriet Robinson, the company's co-founder and senior vice president of research and development, said she had not "anticipated the extent of vaccine control that was achieved in the already infected nonhuman primates," adding the results are "highly promising." Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition, said that the GeoVax primate study is good news but that it is only "one tiny step along the way" (Atlanta Journal-Constitution, 7/9).

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