SOURCE: GeoVax, Inc.

GeoVax, Inc.

June 06, 2016 09:00 ET

GeoVax Developing Vaccine to Treat Chronic Hepatitis B Infection

Expansion of Company's Pipeline of MVA-VLP Vaccines

ATLANTA, GA--(Marketwired - Jun 6, 2016) - GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today the launch of a program to develop a vaccine for treatment of chronic Hepatitis B infections.

The GeoVax vaccine will be based upon the Company's novel MVA-VLP vector platform, which has been proven safe in multiple human clinical trials of GeoVax's preventive HIV vaccine. This platform is also being used by GeoVax to develop preventive vaccines against Zika virus and hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa).

Farshad Guirakhoo, PhD, GeoVax's Senior Vice President of Research and Development, stated, "Our MVA-VLP technology is well-suited for the development of a therapeutic vaccine against the Hepatitis B virus. There is a clear medical need to treat Hepatitis B infections, which affect millions of people around the world. Multiple vaccines exist to protect against Hepatitis B infection, but they cannot help patients already diagnosed with the disease. Although chronic Hepatitis B infections can be treated with drugs, the treatments do not cure 95% of patients; they only suppress the replication of the virus. Therefore, most people who start treatments must continue with them for life. Moreover, diagnosis and treatment options are very limited in resource/low income-constrained populations, which leads to a majority of patients succumbing within months of diagnosis. Within the scientific talent base at GeoVax, we have a good understanding of this disease and are familiar with the obstacles that must be overcome. We believe that our approach to vaccine design and method of treatment has significant merit. Our strategy is to use our therapeutic vaccine in combination with the standard-of-care treatment to reduce the duration of drug therapy, side effects, and potential drug resistance. Our goal is to significantly increase the current cure rate of Hepatitis B infections while reducing the overall treatment costs at the same time."

Commenting on the new program, Robert McNally, PhD, GeoVax's President and CEO, said, "Our entry into the HBV space further demonstrates the broad utility of our MVA-VLP platform and solidifies GeoVax as a leader in the next generation of vaccine developers. We are committed to developing a deep pipeline of products to address high-value, unmet medical needs in our quest to build shareholder value. We look forward to sharing the progress on our HBV vaccine program as it moves forward."

About Hepatitis B Virus

Hepatitis B is a contagious liver disease caused by the Hepatitis B virus (HBV). It is transmitted person-to-person by blood, semen, or other bodily fluids. This can happen through sexual contact, needle sharing, or mother to infant transmission during birth. For some people, Hepatitis B is an acute -- or short-term -- illness; but for others, it can become a long-term, chronic infection that may lead to serious health issues like cirrhosis or liver cancer.

The risk of chronic infection is related to age at infection. Approximately 90% of infected infants will develop chronic infections. As a child gets older, the risk decreases. Approximately 25%-50% of children infected between the ages of 1 and 5 years will develop chronic hepatitis. The risk drops to 6%-10% when a person is infected at over 5 years of age. Worldwide, most people with chronic Hepatitis B were infected at birth or during early childhood.

The CDC estimates that between 700,000 to 1.4 million people in the United States have chronic Hepatitis B virus infections, with an estimated 20,000 new infections every year. Many people are unaware that they are infected or may not show any symptoms. Therefore, they never seek the attention of medical or public health officials. Globally, chronic Hepatitis B affects more than 350 million people and contributes to nearly 800,000 deaths worldwide each year. Despite the fact that a preventive HBV vaccine is available, less than 5% of chronic Hepatitis B infections are cured.

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, Sudan, 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. 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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