SOURCE: GeoVax, Inc.

GeoVax, Inc.

July 01, 2016 09:00 ET

GeoVax Announces Filing of Investigational New Drug Application for HIV Human Clinical Trial

ATLANTA, GA--(Marketwired - Jul 1, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the conduct of the next human clinical trial of GeoVax's preventive HIV vaccine. The IND was filed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Phase 1 trial (designated HVTN 114) will be conducted by the NIAID-supported HIV Vaccine Trials Network (HVTN). The Company expects HVTN 114 to begin enrolling patients in September 2016.

HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase 2a trial of the GOVX-B11 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). 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.

Harriet L. Robinson, Ph.D., GeoVax's Chief Scientific Officer, commented, "HVTN 114 represents the first clinical study of the effect of late boosts, which include a protein boost on the GOVX-B11 DNA/MVA vaccine. The protein boost, AIDSVAX® B/E, is the same protein used to boost immune responses in the partially successful RV144 trial in Thailand. AIDSVAX® B/E is being used to gain an initial assessment of the effect of late boosts of GOVX-B11 while new proteins are being cGMP manufactured for future use."

About 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 NIAID. 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. For more information, go to www.hvtn.org.

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.

About GeoVax

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. The Company's development programs are focused on vaccines against HIV, Zika Virus, and hemorrhagic fever viruses (Ebola virus, Sudan virus, Marburg virus, Lassa virus). GeoVax also recently began programs to evaluate the use of its MVA-VLP platform in cancer immunotherapy, and for therapeutic use in chronic Hepatitis B infections. GeoVax's vaccine platform supports in vivo production of non-infectious virus-like particles (VLPs) from the cells of the very person receiving the vaccine. The production of VLPs in the person being vaccinated mimics virus production in a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, 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: 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 targeted infections in humans, GeoVax's 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.

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