GeoVax and PharmaJet to Collaborate On Development of Needle-Free Vaccine for Zika Virus
Atlanta, GA - (NewMediaWire) August 21, 2018 - GeoVax Labs Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, announced today that it is collaborating with PharmaJet, Inc., on the evaluation of PharmaJet’s needle-free injection system for administration of GeoVax’s Zika vaccine.
The studies to be conducted pursuant to the collaboration will measure the efficacy of the GeoVax vaccine (designated GEO-ZM02) delivered by either syringe and needle or by the PharmaJet needle-free device. The studies will be conducted at the Division of Vector-Borne Diseases, U.S. Centers for Disease Control and Prevention (CDC) in Fort Collins, Colorado with technical assistance from the CDC. Further analysis will be conducted in the laboratories at GeoVax. PharmaJet is supplying its needle-free device and providing technical expertise.
In a previously published study, GeoVax demonstrated that GEO-ZM02 provided 100% protection in normal outbred mice challenged with a lethal dose of Zika virus (ZIKV) delivered directly into the brain. This is the only Zika vaccine in development based solely on the ZIKV NS1 protein, which provided full protection with a single-dose against a lethal ZIKV challenge using an immunocompetent mouse model.
GeoVax selected the ZIKV NS1 antigen as the target immunogen for its vaccine, as recent findings in mice and non-human primates indicate a potential risk of more severe clinical sequelae of subsequent dengue virus infection following traditional vaccination approaches based on the ZIKV envelope proteins. This “Antibody Dependent Enhancement (ADE) of infection” phenomena, previously shown to enhance dengue infections in humans, is now expected to potentially include ZIKV, dengue virus’ closest relative. Results of a new study performed in Rhesus Macaques provides in vivo evidence that prior exposure to ZIKV infection can enhance dengue infections should the individual be subsequently infected by a dengue infected mosquito. An NS1-based vaccine avoids the potential risk of ADE since this protein is not a surface protein on the virus. This approach holds the promise for a highly effective Zika vaccine, that is inherently safer than enveloped-based vaccines for those who live in areas where the ZIKV co-circulates with other flaviviruses such as dengue.
Farshad Guirakhoo, PhD, GeoVax’s Chief Scientific Officer, commented, “We are pleased to be collaborating with PharmaJet, as we believe their needle-free FDA-cleared injection technology could offer benefits over standard needle and syringe vaccine administration, particularly in areas of the world most affected by the ZIKV. We continue to be encouraged by the efficacy of our Zika vaccine, as well as the high safety profile it could present.”
“We are pleased that the PharmaJet devices have been chosen to participate in these important Zika vaccine studies. The needle-free devices are safe, fast and easy to administer and have already been used successfully in boosting vaccine immunogenicity in numerous clinical trials,” said Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc.
Based in Golden, Colorado, PharmaJet’s mission is worldwide acceptance of PharmaJet needle-free devices as a standard of care in the vaccine delivery market. The innovative Stratis® Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® device for intradermal injections received authorization to apply the CE Mark in May 2016 and WHO PQS certification in June 2018. The PharmaJet Needle-free Injectors are safe, fast and easy-to-use. They eliminate needlestick injuries, needle reuse and cross contamination, and help reduce sharps waste disposal. For more information go to: www.pharmajet.com or contact Nancy Lillie, firstname.lastname@example.org, 888-900-4321 option 3.
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platform. GeoVax was the winner of the 2018 “Best Biotech” Vaccine Industry Excellence Awards, a finalist for the 2018 “Best Prophylactic Vaccine” Award for its Zika vaccine at the World Vaccine Congress, as well as a finalist for Pipelines of Promise at Buzz of Bio 2018. The Company’s development programs are focused on vaccines against HIV, Zika, hemorrhagic fever viruses (Ebola, Sudan, Marburg, Lassa) and malaria. GeoVax also is evaluating 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 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.
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. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those under "Risk Factors" in its Form 10-K.