GenPhar announces preliminary results from animal trials of its vaccine for Marburg virus

MOUNT PLEASANT, S.C.–(BUSINESS WIRE)–Oct. 7, 2002–GenPhar today announced preliminary results from animal trials of its vaccine for Marburg virus.

Marburg is a highly lethal hemorrhagic virus, similar to Ebola. The tests were conducted by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) which has identified Marburg virus as a potential biowarfare threat. GenPhar’s multivalent vaccine proved to be 100 percent effective in protecting experimental animals against a very severe challenge of highly concentrated Marburg virus.

USAMRIID is the Department of Defense’s lead laboratory for medical aspects of biological warfare defense. USAMRIID conducts research to develop vaccines, drugs and diagnostics for laboratory and field use. USAMRIID tested the effectiveness of the vaccine in extreme conditions that might be experienced in a biowarfare scenario so the challenge dose of Marburg virus was a thousand times greater than the lethal concentration. In addition, the animals were infected with all three strains of the Marburg virus. All animals in the control group died within days from this fast-acting virus whereas all animals that received the regular dosage of the vaccine were fully protected. Even at very high doses, the vaccine demonstrated no side effects. There are no available vaccines or treatments for Marburg virus that have demonstrated as much potential for providing full protection against this lethal agent as GenPhar’s vaccine. The purchasing authority for USAMRIID has awarded GenPhar a $750,000 phase 1 contract that commenced September 15, 2002 for further testing of the Marburg vaccine. “USAMRIID is at the forefront of vaccine development to mitigate the threat of bioterrorism and biowarfare,” said Dr. John Dong, chief scientific officer of GenPhar. “We expect them to replicate these exciting results in non-human primate trials, which are scheduled to begin soon. The success of these animal trials is an important demonstration of the capacity of the GenPhar vaccine platform and leads us to anticipate similar results with our vaccines against HIV, hepatitis B and hepatitis C.”

This multivalent vaccine for Marburg virus is based on GenPhar’s novel vaccine platform. The universal vaccine platform can be adapted for HIV, hepatitis B and C, and other agents causing infectious diseases of public health and biodefense importance. A similar Ebola vaccine is also under development and will be tested at USAMRIID under the Cooperative Research and Development Agreement (CRADA) between GenPhar and the U.S. Army. Additionally, the National Institutes of Health (NIH) is currently funding and performing preclinical trials in rhesus monkeys with a candidate HIV-1 vaccine developed by GenPhar.

“We intend to make this Marburg vaccine available to the Army and the Department of Health and Human Services in a relatively short period of time,” said Dr. Joseph Sinkule, Vice President for Clinical and Regulatory Affairs. “Prophylactic efficacy trials cannot be ethically conducted with such rare and lethal viruses, and field efficacy trials are not feasible. Under the new FDA regulations, such long-term efficacy trials with vaccines targeted against such agents are no longer needed for marketing approval.”

The vaccine platform was developed upon novel scientific concepts that resulted from years of innovative laboratory research by members of the GenPhar scientific team. The scientific approach differs substantially from those that provide the basis for existing vaccines. GenPhar’s vaccine platform is designed to induce a full spectrum of immune responses against pathogens. No other vaccine technology demonstrated to date has shown itself capable of inducing strong natural production of both highly specific neutralizing antibodies and a potent cytotoxic T-lymphocyte (CTL) or cellular immune responses.

About GenPhar, Inc.

GenPhar, Inc. is a biopharmaceutical company that aims to become the leader in the development of molecular diagnostics, vaccines, and therapeutics for infectious diseases and cancers. GenPhar will develop, manufacture, and market biopharmaceutical products. Its products are divided into three main areas: a vaccine platform applicable to HIV, hepatitis B, hepatitis C, and other infectious diseases; an HIV drug resistance test; and a molecular therapy for solid tumors. These products will have a large-scale impact and transformative effect on current research and treatments. GenPhar was founded in 1999 and is headquartered in the Charleston area of South Carolina. GenPhar can be found online at www.genphar.com.

About the Marburg Vaccine Contract

The U.S. Army Medical Research Acquisition Activity (820 Chandler Street, Fort Detrick, MD 21702-5014) is the awarding and administering acquisition office. The contract award number is: DAMD 17-02-2-0035. The content of the information above does not necessarily reflect the position or the policy of the Government, and no official endorsement should be inferred.

*CONTACT: GenPhar, Inc. Diana Adair, 415/285-1375 [email protected]