| HOME >> BIOLOGY >> TECHNOLOGY |
Therapeutic Clinical Trials - Planning for Phase 1
To help serve those people who are already infected with HIV, the Company is preparing for a Phase 1 therapeutic trial to start in early 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," stated McNally.
He continued, "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."
The initial therapeutic trial will be conducted locally in Atlanta. This first step will be a safety trial using intensive monitoring to verify the ultimate safety of the vaccine.
The Technology
GeoVax's unique two component vaccine, a recombinant DNA and a recombinant modified vaccinia Ankara (MVA), is designed to stimulate both anti-HIV T cell and anti-HIV antibody immu
'/>"/>
| SOURCE GeoVax Labs, Inc. Copyright©2009 PR Newswire. All rights reserved |