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HIV Vaccine Trials Network Opens Enrollment for Phase 1 Trial
of GeoVax Labs' Second Generation HIV Vaccine
Total of 48 Subjects To Be Enrolled at Four Sites Across U.S.
ATLANTA - May 22, 2012- GeoVax Labs, Inc. (OTCBB:GOVX), an Atlanta-based
biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency
Virus (HIV) infections, today announced that the NIH-funded HIV Vaccine Trials Network
(HVTN) has opened enrollment for a Phase 1 trial for the company's second-generation HIV
vaccine. The second-generation vaccine is identical to the first generation (currently in a Phase 2a
clinical trial) except for the inclusion of granulocyte-macrophage colony-stimulating factor (GMCSF)
as an adjuvant (additive) to enhance vaccine responses. GM-CSF is a normal human protein
that promotes the initiation of immune responses. GeoVax's second-generation vaccine coexpresses
GM-CSF with HIV proteins in the DNA priming vaccinations. GM-CSF is not
included in the MVA boost for the GeoVax DNA prime-MVA boost regimen.
The trial, designated HVTN 094, employs a dose-escalation to evaluate the safety and
immunogenicity of the GM-CSF adjuvanted vaccine. In the non-human primate model, coexpression
of GM-CSF in the DNA prime achieved a 90% per exposure reduction in infection, a
significant improvement over the unadjuvanated vaccine. This difference in vaccine efficacy
translated into 70% of vaccinated animals being protected against 12 repeated rectal challenges.
Assuming a successful outcome, the company expects the adjuvanted version of the vaccine to be
carried forward into Phase 2a/2b efficacy testing.
The HVTN 094 trial will enroll a total of 40 vaccinated and 8 control/placebo subjects to be
studied at four sites nationwide: the University of Alabama at Birmingham; Brigham and
Women's Hospital, Boston; the University of Rochester, and the San Francisco Department of
Public Health. The first inoculation was given at Brigham and Women's Hospital, Boston.
Funding for HVTN's conduct of the trial will come from the National Institute of Allergy and
Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH).
Robert McNally, Ph.D, President and Chief Executive Officer of GeoVax, said, "We are
extremely pleased the HVTN is conducting the trial with the adjuvanted vaccine. They have
substantial experience with our unadjuvanted vaccine and possess appropriate expertise for this
first human trial of our GM-CSF co-expressing vaccine that has shown such good promise in
preclinical studies."
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About GeoVax Labs, Inc.
GeoVax Labs, Inc. is a biotechnology company developing human vaccines for HIV (Human
Immunodeficiency Virus - that leads to AIDS). GeoVax's HIV/AIDS vaccine technology is
exclusively licensed from Emory University in Atlanta, GA, and is the subject of more than 20
issued or filed patent applications. GeoVax vaccines are designed for use in uninfected people to
prevent acquisition of HIV-1 and limit the progression to AIDS should a person become infected.
GeoVax vaccines are also being tested as a therapeutic treatment (for people already infected with
the HIV-1 virus).
GeoVax's core vaccine technologies were developed by Dr. Harriet Robinson, Chief Scientific Officer,
through a collaboration of colleagues at Emory University's Vaccine Center, the National Institute of
Allergy and Infectious Diseases (NIAID), the Centers for Disease Control and Prevention (CDC) and
GeoVax. The technology uses recombinant DNA to prime the immune response and recombinant
modified vaccinia Ankara (MVA) to boost the primed response. Both the DNA vaccine and the MVA
vaccine express non-infectious virus-like-particles displaying the natural trimeric form of the HIV
envelope protein.
GeoVax's vaccines have moved forward in human clinical trials conducted by the HIV Vaccine Trials
Network (HVTN) based in Seattle, Washington. These trials have tested various combinations and doses
of the DNA and MVA vaccines, their ability to raise anti-HIV humoral (antibody) and cellular (cytotoxic
T cell) immune responses, as well as, the vaccines' safety. Successful results from Phase 1 testing
supported Phase 2 testing in an ongoing, fully enrolled, 299 participant trial in North and South America.
The vaccine is also undergoing Phase 1 /2 testing as a therapeutic in HIV-infected individuals.
About the HVTN
The HVTN is the largest worldwide clinical trials network dedicated to the development and testing of
preventive HIV/AIDS vaccines. The HVTN is an international collaboration that conducts all phases of
clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune
responses, to testing vaccine efficacy. Support for the HVTN comes from the National Institute of Allergy
and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). The Network's
HIV Vaccine Trial Units are located at leading research institutions in 27 cities on four continents. The
Network's headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington.
About NIAID
NIAID conducts and supports research-at NIH, throughout the United States and worldwide-to study
the causes of infections and immune-mediated diseases, and to develop better means of preventing,
diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are
available on the NIAID Web site at http://www.niaid.nih.gov/.
For more information, please visit www.geovax.com.
Forward-Looking Statements
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act. These statements are based on management's current expectations and are subject to
uncertainty and changes in circumstances. Actual results may differ materially from those included in these
statements due to a variety of factors, including whether: HVTN will commence, complete enrollment, and generate
data regarding GeoVax vaccine clinical trials as and when expected, GeoVax can develop and manufacture its
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, less costly, or easier to use than GeoVax's products, GeoVax will
be able to enter into favorable manufacturing and distribution agreements, 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. More information about these factors is contained in GeoVax's filings with the Securities and Exchange
Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.
Contact
The Investor Relations Group:
Erika Moran, Investor Relations
Janet Vasquez, Public Relations
(212) 825-3210
"Reproduced with permission - GeoVax Labs, Inc."
GeoVax Labs, Inc.
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