Phase 1 clinical trial for Hantavirus vaccines yields positive interim results

GOLDEN, Colo., March 13, 2018 /PRNewswire/ --PharmaJet®, the maker of innovative, needle-free injection technology, today announced the reporting of positive interim results from the Phase 1 clinical trial conducted by the US Army Medical Research Institute of Infectious Diseases (USAMRIID). The clinical trial is evaluating two hantavirus vaccines to prevent hemorrhagic fever with renal syndrome (HFRS), using the PharmaJet Stratis® needle-free injection system. Hantaan virus (HTNV) causes the most severe form of HFRS, which has a 5 to 15 percent fatality rate and affects tens of thousands of people annually. Currently no vaccine is available.1

PharmaJet's delivery device was chosen for this Phase 1 trial after pre-clinical studies with similar vaccines showed significantly higher (tenfold increase) immunogenicity with the needle-free device, as compared to needle and syringe, and comparable results to electroporation.2 "The interim immunogenicity results in the Phase 1 trial look promising, and the PharmaJet needle-free device has an excellent safety profile in humans," said Jay W. Hooper, Ph.D., Chief, Molecular Virology Branch, Virology Division, USAMRIID. "An added benefit of the needle-free injector is that it eliminates needles completely from the process of administering vaccines, as well as the costs and dangers associated with sharp-needle waste."

"We are pleased with the interim results from the Phase 1 clinical trial for a hantavirus vaccine that has the potential to save lives," said Ron Lowy, Chairman and Chief Executive Officer, PharmaJet Inc. "Our needle-free devices are continuing to help novel DNA technologies move successfully from pre-clinical studies into early and late stage clinical trials."

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          Data on file. Refer to
      Instructions for Use to ensure
       safe injections and to review

    1 J.W. Hooper, et al, DNA
     Vaccination with Hantaan Virus M
     Gene Protects Hamsters against
     Three of Four HFRS Hantaviruses
     and Elicits a High-Titer
     Neutralizing Antibody Responses
     in Rhesus Monkey, Journal of
     Virology, September 2001, p.8469
     0 8477

    2 Steve Kwilas et al, A
     Hantavirus Pulmonary Syndrome
     (HPS) DNA Vaccine Delivered
     Using a Spring-powered Jet
     Injector Elicits a Potent
     Neutralizing Antibody Response
     in Rabbits and Nonhuman
     Primates, Current Gene Therapy,
     May 2014, 14, 200-210

[The information contained in this press release does not necessarily reflect the position or the policy of the Government and no official endorsement should be inferred.]

Nancy Lillie
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