New Clinical Trial Planned With HVTN and NIH Support; Concept Protocol Approved for HVTN 114
ATLANTA, GA--(Marketwired - Apr 1, 2015) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines for Ebola and HIV, today announced that the HIV Vaccine Trials Network (HVTN) has assigned a trial number, HVTN 114, to the next clinical trial of its clade B preventive HIV vaccine candidate.
HVTN 114, titled: "A Phase 1 clinical trial to evaluate the immunogenicity of AIDSVAX® B/E bivalent gp120 vaccine and MVA/HIV62B in healthy, HIV-1 uninfected adult participants who previously received MVA/HIV62B in DNA/MVA or MVA/MVA regimens in HVTN 205," is expected to begin enrolling patients during the second half of 2015.
HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase 2a trial of the GeoVax vaccine (concluded in 2012) and will test the ability of late boosts to increase the antibody responses elicited by the GeoVax vaccine. The late boosts will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, will be supplied by Global Solutions for Infectious Diseases (GSID) and is the same protein used to boost immune responses in the partially successful RV144 vaccine trial in Thailand. Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone. HVTN 205 included two different vaccine regimens; HVTN 114 will allow for five separate study groups (up to 20 in each group), and participants will be assigned to each group depending upon their initial vaccine regimen from HVTN 205.
The primary objectives of the trial are (a) to determine the safety of MVA62B and AIDSVAX B/E given separately or together as boost injections after prolonged immunologic rest, to participants who received vaccinations in HVTN 205, and (b) to compare HIV-specific antibody responses to MVA62B and AIDSVAX B/E given separately or together. Secondary objectives are to further characterize HIV-specific antibody and T cell responses to MVA62B and AIDSVAX B/E given separately or together, and to compare durability of the responses at 6 months after the boosts.
Harriet L. Robinson, Ph.D., GeoVax's Chief Scientific Officer, commented, "Protein boosts were important for the one partially successful HIV vaccine trial, RV144, and we will be testing the effect of the same boost used in RV144 on our vaccine. We believe the HVTN and its funding agency, the National Institute of Allergy and Infectious Disease (NIAID), are taking the prudent step to evaluate the impact of protein boosts in combination with GeoVax vaccines. Information from this trial will inform the design of future, larger, clinical trials. We are pleased that HVTN approved the concept protocol for HVTN 114 and we look forward to taking the steps necessary for initiation of the trial and commencement of patient enrollment."
About the HVTN
The HIV Vaccine Trials Network (HVTN) is the largest worldwide clinical trials network dedicated to the development and testing of 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 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 Global Solutions for Infectious Diseases
Global Solutions for Infectious Diseases (GSID) is a non-profit global health organization engaged in the development of diagnostic and preventive tools for infectious diseases, including HIV. GSID provides assistance to, and collaborates with, global public health organizations, private foundations, other non-governmental organizations and for-profit entities focused on public health issues and infectious diseases. The focus of GSID is to facilitate the access to affordable health solutions for the benefit of the people most in need, particularly in developing countries. For more information, go to www.gsid.org.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases using our novel vaccine platform. Our current development programs are focused on vaccines against Ebola and Marburg viruses, and vaccines against Human Immunodeficiency Virus (HIV). We believe our technology and vaccine development expertise is well-suited for a wide variety of human infectious diseases for which there is an unmet medical need, and we intend to pursue expansion of our product pipeline as resources permit.
Our vaccine platform supports production of non-infectious virus-like particles (VLPs) from the cells of the person receiving the vaccine. Producing non-infectious virus-like particles in the person being vaccinated circumvents the need to purify virus-like particles for inoculation. The production of virus-like particles in the person being vaccinated mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent and control the target infection should it appear.
Clinical trials for GeoVax's preventive HIV vaccines have been conducted by the US National Institutes of Health-supported HIV Vaccine Trials Network (HVTN) with funding from the National Institute of Allergy and Infectious Disease (NIAID). Overall, GeoVax's vaccines, in various doses and combinations, have been tested in close to 500 humans. For more information, go to www.geovax.com.
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: 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 HIV or Ebola infection 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, 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.
Adam S. Holdsworth
PCG Advisory Group
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