SOURCE: GeoVax, Inc.

GeoVax, Inc.

April 18, 2016 09:00 ET

GeoVax Provides Update on Zika Vaccine Program

Multiple Collaborations; Animal Testing Imminent; Federal Funding Being Sought

ATLANTA, GA--(Marketwired - Apr 18, 2016) -  GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, provided an update today on its program to develop a safe and effective vaccine to prevent Zika virus infection in humans. No approved vaccine currently exists for this rapidly spreading mosquito-borne disease.

A turning point in the Zika outbreak came after a publication by the Centers for Disease Control and Prevention (CDC) in the New England Journal of Medicine on April 13, 2016, which confirmed that the Zika virus causes severe birth defects, including microcephaly -- a condition where children are born with unusually small heads. As the understanding about Zika virus expands, health agencies around the country have become increasingly alarmed. GeoVax has responded to this sense of urgency by forming a number of collaborations to speed the development process of a safe and effective vaccine.

Under the leadership of Dr. Farshad Guirakhoo, GeoVax's scientific team has engaged with scientists at three renowned institutions: the CDC for animal testing and access to Zika convalescent sera to help in vaccine development; the University of Georgia (UGA) for alternative animal testing models and vaccine development; and the University of Texas Medical Branch (UTMB) for additional reagents necessary for testing GeoVax's vaccine candidates.

The GeoVax vaccine (designated GOVX-ZM01) utilizes the company's proven Modified Vaccinia Virus Ankara - Virus-Like Particle (MVA-VLP) platform that supports in vivo production of non-infectious VLP 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 antibody and T cells arms of the immune system to recognize, prevent, and control the target infection. GeoVax's HIV and Ebola vaccine programs provide ample data to prove the efficacy of this technique. The GeoVax MVA-VLP vaccine vector has been proven safe in multiple human clinical trials, and the company believes it is uniquely suited to produce an effective and durable immune response against the Zika virus.

Dr. Robert McNally, PhD, GeoVax's President and CEO, commented, "Supported by the world-class scientific team we have assembled, our vaccine construction is progressing rapidly and we expect to initiate animal studies next month. Earlier this month, we submitted an application for a Small Business Innovative Research (SBIR) grant to help fund our vaccine program. President Obama has renewed his request for congressional allocation of $1.9 billion specifically to combat the Zika virus; we intend to take full advantage of federal funding set aside for vaccine development as it becomes available."

About Zika Virus
On February 1, 2016, the World Health Organization (WHO) designated the Zika virus and its suspected complications in newborns an international public health emergency. A total of 62 countries and territories worldwide (33 in the Americas) have reported local transmission of the virus, with 6 countries (Argentina, Chile, France, Italy, New Zealand, and the USA) now reporting locally acquired infections through sexual transmission. The WHO projects that the disease could reach most of the Western Hemisphere, infecting up to 4 million people, by year's end. The CDC has issued a travel advisory for people traveling to regions within the Zika virus outbreak, which include popular vacation destinations. Brazil, the site of the 2016 Summer Olympic Games, is included in this advisory.

Zika virus, transmitted to humans primarily through the bite of the Aedes species mosquito (A. aegypti and A. albopictus), is a member of the Flaviviridae family, which includes medically important human pathogens such as dengue fever, yellow fever, Japanese encephalitis, tick-borne encephalitis, and West Nile viruses. There is scientific consensus that the Zika virus causes infant microcephaly and Guillain-Barré syndrome (GBS), a rare autoimmune disorder that can cause paralysis. Microcephaly and other fetal abnormalities have been reported in Brazil (1046 cases), Cabo Verde (2 cases), Columbia (7 cases), French Polynesia (8 cases), Martinique (3 cases) and Panama (1 case). Thirteen countries have reported increased incidence of GBS and/or laboratory confirmation of a Zika infection among GBS cases.

Other than mosquito control, no approved preventive or therapeutic products are currently available to fight Zika infections. Public health officials recommend avoiding exposure to Zika, delaying pregnancy, and following basic supportive care after infection. A vaccine is urgently needed to prevent a Zika pandemic.

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, Marburg, Lassa). GeoVax also recently began programs to develop a vaccine against the Zika virus, and to evaluate the use 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 funding from the National Institute of Allergy and Infectious Disease (NIAID). 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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