News
| 2009-06-05 |
GenPhar to begin manufacture of its tetravalent dengue vaccine for Phase I clinical trials |
| US Navy and GenPhar working together to conduct Phase I clinical trial to fight fatal disease caused by all serotypes of dengue viruses. Mount Pleasant, South Carolina, United States of America, June 5, 2009 |
| GenPhar, Inc. announced that it has signed an exclusive collaboration agreement with the United States Naval Medical Research Center (NMRC) for GenPhar’s tetravalent dengue vaccine, the next-generation vaccine to be used to prevent disease caused by all four serotypes of the dengue virus. Manufacturing of this vaccine will begin in July. Under the terms of GenPhar’s agreement with the NMRC, GenPhar will continue to perform the vaccine’s advanced development activities. GenPhar will be responsible for the construction, characterization, animal testing, cGMP manufacturing, and GLP toxicity testing of the vaccine prior to clinical trials. The NMRC will be responsible for the initiation of the Phase I clinical trials. GenPhar will retain all rights, including global intellectual property and distribution rights. GenPhar will receive a payment of US$ 2.2 million in the form of milestone payments. Using its proprietary and patent-protected vaccine platform technology and in collaboration with the NMRC, GenPhar has developed a tetravalent vaccine that prevents infection by all four serotypes of the dengue virus. Preclinical studies in nonhuman primates demonstrated that the vaccine provides protection against challenge by all four dengue serotypes. Vaccinated animals produced high-titer antibodies that neutralized all four serotypes of dengue viruses in vitro. GLP toxicology studies demonstrated that the vaccine platform is well tolerated at high doses, with no significant adverse events or side effects. GenPhar and the NMRC expect to enter Phase I clinical trials in the first half of 2010. Peak sales for GenPhar's tetravalent dengue vaccine are expected to exceed US$ 300 million. The NMRC is well renowned as a research institute that enhances the health, safety, readiness, and performance of Navy and Marine Corps personnel through basic and applied biomedical research. The NMRC seeks solutions against the potential use of weapons of mass destruction and terrorism against its military forces and US citizens. The research at NMRC is focused on improving readiness and enhancing future capabilities through vital work in the areas of infectious diseases, biological defense, military operational medicine, combat casualty care, and radiation research, all in support of Navy, Marine Corps, and joint US warfighters. About dengue Dengue virus infection can result in, shock, encephalitis, hemorrhagic fever and death. About 2.5 billion people live in dengue infested areas. There are 100 million new cases each year, with over 500,000 cases requiring hospitalization, resulting in severe social disruption and economic impact worldwide. About GenPhar’s platform technology ProVax is GenPhar's vaccine technology for the prevention of disease caused by deadly viral pathogens. Using the ProVax platform, GenPhar has developed multivalent vaccines for Marburg, Ebola, a combination of Marburg and Ebola, and dengue viruses. GenPhar's Ebola and Marburg vaccines achieved unprecedented results in U.S. Army challenge experiments by demonstrating 100% protective efficacy with no side effects or liver damage. Both vaccines are approaching human trials in continued collaboration with the U.S. Army, while GenPhar's tetravalent dengue vaccine is scheduled for human trials in collaboration with the U.S. Navy. In addition to collaborative contracts with the U.S. Army and Navy, GenPhar has funding from NIH to continue its biodefense vaccine programs and to provide vaccines for the protection of our troops and our nation. About GenPhar, Inc. GenPhar, Inc. is a biopharmaceutical company dedicated to leadership in developing and producing prophylactic and therapeutic vaccines against the world’s most dangerous diseases. To reach its goals, GenPhar will leverage the advantage of its proven safe and effective ProVax and TheraVax vaccine platforms -- unique technology capable of producing multiple vaccine products. GenPhar's products are divided into two main areas: vaccines for biodefense and vaccines for chronic infectious diseases (including HIV, hepatitis B and hepatitis C). These products will have a transformative effect on current research and treatments, and large-scale socio-economic impact. GenPhar was founded in 1999 and is headquartered in Mount Pleasant, South Carolina. Forward-looking statements Except for the historical information contained herein, this release contains “forward-looking statements” within the meaning of the Private Securities Reform Act of 1995. No “forward-looking statement” can be guaranteed, and actual results may differ materially from those projected. GenPhar, Inc. undertakes no obligation to publicly update any “forward-looking statement”, whether as a result of new information, future events, or otherwise. For further information please contact: Katy Donovan GenPhar, Inc. (843) 884-0129 kdonovan@genphar.com |
| About GenPhar, Inc. GenPhar, Inc. is a biopharmaceutical company dedicated to becoming a leader in developing and producing prophylactic and therapeutic vaccines to protect against the world’s most dangerous diseases. To reach its goals, GenPhar will leverage the advantage of its proven safe and effective ProVax and TheraVax vaccine platforms -- unique technology capable of producing multiple vaccine products. GenPhar's products are divided into two main areas: vaccines for biodefense and vaccines for chronic infectious diseases (including HIV, hepatitis B and hepatitis C). These products will have a large scale socio-economic impact and transformative effect on current research and treatments. GenPhar was founded in 1999 and is headquartered in Mount Pleasant, South Carolina. To learn more about GenPhar and its vaccine programs, please contact us. |
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