SOURCE: GeoVax, Inc.

GeoVax, Inc.

June 01, 2016 09:00 ET

GeoVax Ebola Vaccine Protects Non-Human Primates Against Lethal Challenge

Single Dose Provided 100% Protection, Tetravalent Hemorrhagic Fever Virus Vaccine Under Development

ATLANTA, GA--(Marketwired - Jun 1, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that testing of its Ebola vaccine in non-human primates showed 100% protection against a lethal Ebola virus challenge.

The GeoVax Ebola vaccine is based on the Company's novel Modified Vaccinia Ankara (MVA) Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated. VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells. The GeoVax MVA-VLP platform has already demonstrated outstanding safety in four clinical trials for the Company's HIV vaccine candidates, which included 500 participants.

In this study, GeoVax's MVA-VLP vaccine against Ebola virus (Zaire ebolavirus; the cause of the 2014 outbreak) was administered as either a single inoculation (prime) or as two inoculations at a four week interval (prime-boost) to groups of four rhesus macaques each. A control group received the MVA vector without Ebola virus protein inserts. Four weeks after inoculation, animals in all three groups were exposed to a lethal dose of Ebola virus. Three of the four unvaccinated animals died within 12 days, while all of the vaccinated animals survived. Researchers at Rocky Mountain Laboratories, part of the National Institute of Allergy and Infectious Diseases (NIAID), collaborated in the study. 

"This trial is particularly encouraging because it shows that a single dose of our MVA-VLP Ebola vaccine is sufficient for protection against a lethal challenge. This is not only important for the control of natural Ebola outbreaks, but also for rapid control of Ebola intentionally released as a bioterrorism agent," said Dr. Farshad Guirakhoo, Ph.D., GeoVax's Senior Vice President, Research and Development.

GeoVax's MVA-VLP vaccine against the Ebola virus is one component of a tetravalent hemorrhagic fever virus vaccine being developed by GeoVax. The other components are Sudan virus (Sudan ebolavirus), Marburg virus, and Lassa virus MVA-VLP vaccines. These vaccines are envisioned as either individual vaccines in epidemic situations or combined as a tetravalent vaccine for the protection of the millions of individuals who live in at-risk areas, travelers, military personnel, healthcare workers, and others.

Robert McNally, PhD., GeoVax's President & CEO, commented, "We are very pleased with the results of this study, and now turn our attention to completing characterization and testing of our tetravalent vaccine. This proof-of-concept study in non-human primates for the Zaire ebolavirus component of our tetravalent vaccine gives us very high confidence in our program."

About Hemorrhagic Fever Viruses

Hemorrhagic fevers caused by Filoviruses (Ebola virus, Sudan virus, and Marburg virus) and Arenaviruses, such as Lassa virus, are considered neglected infectious diseases with no licensed vaccines or effective therapeutics available. Currently, for Lassa fever treatment, ribavirin is used but it is only effective if given within the first 6 days after disease onset. These viral hemorrhagic fevers are epidemic/endemic in 22 African countries, and could be intentionally used as biological warfare agents. The 2014 Ebola outbreak in western Africa was the 28th recorded outbreak of the Ebola virus, infecting 28,652 individuals resulting in 11,325 deaths. Lassa virus causes severe and often fatal hemorrhagic illness in an overlapping geographical region with Filoviruses. In contrast to the unpredictable epidemics of filoviruses, Lassa virus is endemic in West Africa with an annual incidence of >300,000 infections, resulting in 5,000-10,000 deaths. Data from a recent sero-epidemiologic study suggest that the number of annual Lassa virus cases may be much higher, reaching three million infections and 67,000 deaths, putting as many as 200 million persons at risk (Leski TA, et al., Emerging Infectious Diseases 21 (2015)). The lessons learned from the recent Ebola outbreak indicate that the urbanization of Africa contributes to the rapid spread of such pathogens. If not contained, they can cause global epidemics.

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 most advanced development programs are focused on vaccines against HIV and hemorrhagic fever viruses (Ebola virus, Sudan virus, Marburg virus, and Lassa virus). In addition, GeoVax recently initiated vaccine development against Zika virus, and evaluation of its MVA-VLP platform in cancer immunotherapy. GeoVax's vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine. The production of VLPs 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.

Clinical trials for GeoVax's preventive HIV vaccines have been conducted by the NIH-supported HIV Vaccine Trials Network (HVTN) with NIAID funding. Overall, GeoVax's HIV vaccines, in various doses and combinations, have been tested in 500 humans with very encouraging results. Currently, GeoVax has the most advanced vaccine for the subtype of HIV prevalent in North America and Western Europe. The company awaits funding for a Phase 2b efficacy trial to prove the vaccine protects against HIV. 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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