GeoVax has provided updates on its ongoing and planned human clinical trials – Phase 2a Preventive and Phase 1 Therapeutic (in the planning stage).
The Preventative trial, designated as HVTN 205, is being conducted by the HVTN. HVTN is funded and supported by the National Institutes of Allergy and Infectious Diseases (NIAID). The trial is expected to include a total of 225 volunteers (150 vaccine recipients and 75 placebo recipients), and would take place at 13 HVTN sites.
The Therapeutic trial is in the planning stage that the company is going to start in early 2010. It is meant to help serve those who are already infected with HIV with the goal to reduce the need for anti-viral drugs.
Robert McNally, CEO and president of GeoVax, said: We have two main areas of focus for our HIV/AIDS vaccine – preventative and therapeutic. The results of the early Phase 1 clinical work for the preventative version of the vaccine have allowed the company to move up to another level of analysis, Phase 2a human clinical trial. This trial was initiated by the HIV Vaccine Trials Network (HVTN) in February this year and we are pleased to report that the HVTN has currently enrolled 30% of the projected participants. On the therapeutic front, we are in the midst of planning the details of a Phase 1 human clinical trial and expect to begin this trial, assuming FDA approval, in the first quarter of 2010.
The goal here is to reduce the need for anti-viral drugs. This initial trial will determine the safety and immunogenicity of the vaccine in patients with well controlled infections who started on drugs within six months of testing positive for HIV, he added.
You will recall that trials conducted using a simian immunodeficiency virus (SIV) prototype of the GeoVax HIV vaccine in SIV-infected primate animal models have held high promise that the GeoVax vaccine will be able to contribute to the control of HIV-1 in already infected humans. Our team is working hard to develop the clinical trial protocol and to assemble all the information required for an FDA submission seeking approval to move forward with the clinical trial. We plan to submit our package to the FDA in the very near future, Mr. McNally concluded.