GeoVax Labs, Inc. Provides Clinical Studies Update
ATLANTA, Aug. 5 /PRNewswire-FirstCall/ -- GeoVax Labs, Inc. (OTC
Bulletin Board: GOVX), an Atlanta-based HIV/AIDS vaccine
development company, today announced updates on its ongoing and
planned human clinical trials.
"We have two main areas of focus for our HIV/AIDS vaccine -
preventative and therapeutic," stated Robert McNally, Ph.D., Chief
Executive Officer and President of GeoVax Labs, Inc. "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."
Preventative Clinical Trials - Phase 2a
The preventative trial, designated as HVTN 205, is being
conducted by the HVTN. The HVTN, funded and supported by the
National Institutes of Allergy and Infectious Diseases (NIAID), is
the largest worldwide clinical trials network dedicated to the
development and testing of HIV/AIDS vaccines. The HVTN has
sponsored over 80 Phase 1 trials for the initial evaluation of
safety and immunogenicity of candidate HIV/AIDS vaccines. The
results of these trials have merited only five phase 2 trials.
Progressing to Phase 2 is a significant step for GeoVax. The first
injections for the Phase 2a trial were conducted at the HVTN
network sites at the University of Alabama, Birmingham, and
Vanderbilt University, Nashville.
The trial is still expected to include a total of 225 volunteers
(150 vaccine recipients and 75 placebo recipients) and take place
at 13 HVTN sites: 11 in North America and two in South America.
Sites in the United States include Emory University, Atlanta;
Harvard Medical School, Boston; Vanderbilt University, Nashville;
University of Rochester; Fred Hutchinson Cancer Research Center,
Seattle; the San Francisco Department of Public Health; University
of Alabama, Birmingham and sites at Columbia University, Union
Square, and the Bronx in New York City. In South America,
participants are to be enrolled in Peru at sites in Iquitos and
Miraflores (Lima).
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 immune
responses. Stimulation of both T cells and antibodies
differentiates the GeoVax vaccine from many other vaccine
candidates. GeoVax's DNA and MVA vaccines are used in a prime-boost
protocol in which priming is done with the DNA and boosting with
the MVA. Both the DNA and MVA express the three major proteins of
the AIDS virus: Gag, Pol, and Env, and produce non-infectious
virus-like-particles. These particles contain proteins that mimic
more than half of the components of the AIDS virus, but cannot
cause AIDS. This multi-protein approach is designed to elicit a
broad multi-target protective T cell response. The Env protein is
designed to elicit a protective antibody response against the
natural form of the virus envelope glycoprotein as well as
protective T cells.
"Vaccine trials can be a slow process," said Harriet Robinson,
Ph.D., developer of the vaccine and Senior V.P. of Research and
Development. "The therapeutic trials should move more rapidly than
the preventative trials because each participant provides not only
endpoints for safety and immunogenicity, but also an endpoint for
protective efficacy. But, before these trials can scale up, we need
to demonstrate safety for our participants in both vaccination and
subsequent phases of therapeutic studies. We have safety and
efficacy data for non-human primates. The next step is determining
safety in a small trial of intensively monitored humans."
About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company, established to
develop, manufacture, license and commercialize human vaccines for
diseases caused by HIV-1 (Human Immunodeficiency Virus) and other
infectious agents. GeoVax's AIDS vaccine technology is the subject
of 20 issued or filed patent applications. GeoVax AIDS vaccines are
designed for use in uninfected people to prevent Acquired
Immunodeficiency Disease (AIDS), caused by the virus known as
HIV-1, should the person ever become infected. GeoVax AIDS vaccines
also may be effective as therapeutics (treatment of people already
infected with HIV).
GeoVax's core AIDS vaccine technologies were developed by Dr.
Harriet Robinson, Senior V.P. of Research and Development, through
a collaboration of colleagues at Emory University's Vaccine Center,
the National Institutes of Health (NIH), The Centers for Disease
Control and Prevention (CDC) and GeoVax.
GeoVax's AIDS vaccines have moved forward in human clinical
trials conducted by the HIV Vaccine Trials Network (HVTN) based in
Seattle, Washington. The HVTN, funded through a cooperative
agreement with the National Institutes of Health (NIH), is the
largest worldwide clinical trials program dedicated to the
development and testing of AIDS vaccines. Preclinical work enabling
evaluation of GeoVax DNA and MVA vaccines was funded and supported
by NIAID, which provided additional support to GeoVax AIDS vaccine
development program with a $17 million IPCAVD grant awarded in late
2007.
Safe Harbor Statement
All statements in this news release, not statements of
historical fact, are forward-looking statements. These statements
are based on expectations and assumptions on the date of this press
release and are subject to numerous risks and uncertainties which
could cause actual results to differ materially from those
described in the forward-looking statements. Risks and
uncertainties include, but are not limited to, whether: GeoVax can
develop and manufacture these vaccines with the desired
characteristics in a timely manner, GeoVax's vaccines will be safe
for human use, GeoVax's vaccines will effectively prevent AIDS in
humans, vaccines will receive regulatory approvals necessary to be
licensed and marketed, GeoVax raises required capital to complete
vaccine development, there is development of competitive products
that may be more effective or easier to use than GeoVax's products,
and other factors over which GeoVax has no control. GeoVax assumes
no obligation to update these forward-looking statements, and does
not intend to do so. Certain matters discussed in this news release
are forward-looking statements involving certain risks and
uncertainties including, without limitation, risks detailed in the
Company's Securities and Exchange Commission filings and
reports.
For more information on GeoVax Labs, Inc., please visit the
Company's website at www.geovax.com
Source: GeoVax Labs, Inc.
CONTACT: Robert McNally of GeoVax Labs, Inc.,
+1-404-727-0971,
rmcnally@geovax.com; or Leslie
Loyet, Investor Relations, +1-312-640-6672,
lloyet@mww.com, or Nikki Snodgrass,
Media Relations, +1-312-640-6732,
nsnodgrass@mww.com, both of
Financial Relations Board, for GeoVax Labs, Inc.
Web Site: http://www.geovax.com
Posted: August 2009
