Peregrine Pharmaceuticals establishes a new Anti-Viral Research Group

Oct 7 2009

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM) today announced that it has established a new Anti-Viral Research Group in its R&D organization. The new group has responsibility for coordinating, expanding and leveraging the company's multiple external collaborations already underway or planned to assess the potential utility of Peregrine's phosphatidylserine (PS)-targeting antibody platform for the prevention and treatment of a broad range of serious infectious diseases, including viral hemorrhagic fevers (VHF) and other biodefense threats, HIV, influenza, cytomegalovirus (CMV), leishmaniasis and malaria.

Peregrine's broad-spectrum PS-targeting antibodies are being assessed in anti-infective applications by more than a dozen leading research institutions. These collaborative efforts include studies assessing PS-targeting antibodies as potential therapeutics for HIV, VHF and CMV; studies assessing anti-PS antibodies as vaccines or vaccine adjuvants for the prevention of HIV and other infectious diseases; and studies of PS-targeting antibodies as potential topical microbicides against sexually transmitted diseases such as HIV and herpes viruses. Peregrine and its collaborators have already secured over $60 million in research funding to evaluate the potential of the company's PS-targeting platform in a wide range of viral infections, and Peregrine researchers believe there is significant potential for additional applications of the technology in other infectious diseases.

"We are establishing our new Anti-Viral Research Group to maximize the clinical and commercial potential represented by the increasing interest from major research institutions and private and public funding agencies in studying our PS-targeting antibody platform as a novel approach to the prevention and treatment of a range of serious infectious diseases," said Steven W. King, president and CEO of Peregrine. "A growing body of published scientific research confirms that PS plays an important role in the development of many serious viral diseases, as well as in protozoan-caused illnesses such as malaria and leishmaniasis, conditions that impact the lives of millions of people worldwide each year. We believe that our PS-targeting antibody platform has the potential to address the large commercial markets represented by these diseases and to significantly impact the well-being of people around the globe. As a result, we see many opportunities to both optimize our current collaborations and to obtain new funding and support from additional external sources. This is the focus and mission of the Anti-Viral Research Group, and we are confident that it will be successful in identifying additional resources to help advance our PS-targeting anti-infective programs in the near and mid-term."

PS, a lipid molecule normally found only on the inside of cell membranes, becomes exposed on the outside of the membranes of certain viruses and virally infected cells. A rapidly growing body of published scientific research confirms that exposed PS is directly involved in the pathogenesis of many serious infectious diseases. Exposed PS enables viruses to evade immune recognition and dampens the body's normal responses to infection. By masking the exposed PS, PS-targeting antibodies are believed to block these effects, allowing the body to develop a robust immune response to the pathogen. Peregrine's PS-targeting antibodies have been shown to help clear infectious virus from the bloodstream and to induce antibody-dependent cellular cytotoxicity. Researchers have found that PS is exposed on the outer membrane of cells infected with HIV, influenza, herpes simplex viruses, hemorrhagic fever viruses, measles and members of the smallpox and rabies virus families. Scientists have also found that PS is exposed in certain infections caused by protozoan organisms, such as malaria and leishmaniasis.

Bavituximab, which is Peregrine's most advanced PS-targeting antibody, is currently being studied in a clinical trial for the treatment of patients co-infected with HCV and HIV. Phase I studies in HCV patients showed that bavituximab was well tolerated and it exhibited encouraging signs of anti-viral activity.

Peregrine's anti-PS antibodies are also generating positive data in preclinical HIV studies conducted by researchers from leading universities and medical research institutions in the U.S. and U.K. with funding from the Bill and Melinda Gates Foundation and the National Institutes of Allergy and Infectious Diseases (NIAID). These studies have yielded promising results that support the potential of PS-targeting agents for use as therapeutics, in vaccines and as topical microbicides, an especially promising application urgently needed in the effort to help women avoid infection with HIV and other sexually transmitted diseases such as herpes viruses and chlamydia. In addition, collaborators are also investigating the utility of PS-targeting antibodies against CMV infections and leishmaniasis, a protozoan disease that attacks people and cattle in tropical regions, with devastating effects on both health and economic well-being.

Under a major biodefense initiative funded by the Defense Threat Reduction Agency for the Transformational Medical Technologies Initiative (TMTI), bavituximab and a fully human equivalent antibody are in preclinical development for the treatment of viral hemorrhagic fevers under a contract worth up to $44.4 million. This contract, which is funding work at Peregrine and at several collaborating institutions, was awarded based on positive data from earlier studies in animals infected with VHF that was funded by a previous grant from NIAID. This work is going well, and Peregrine intends to report early results at an upcoming biodefense conference. NIAID also recently awarded a new VHF grant to Peregrine's collaborators at UT Southwestern Medical Center.

Dr. Amy Brideau-Andersen will be directing the new Anti-Viral Research Group. Before joining Peregrine in 2006, she played an important role in the discovery and development of novel anti-viral drugs at Valeant Pharmaceuticals and at Maxygen, Inc. Dr. Brideau-Andersen completed her post-doctoral training in virology at The Scripps Research Institute. She earned B.S/M.S. degrees from Worcester Polytechnic Institute and was awarded a Ph.D. in molecular biology from Princeton University.

"As a virologist, I am excited about the opportunity to lead this initiative," said Dr. Brideau-Andersen. "PS is a novel host-derived target that is present in many different viral infections. It has the potential to help harness the body's own immune defenses to combat infection while avoiding the problems of resistance that have limited the utility of many anti-viral agents. We look forward to working proactively with both our current collaborators and with the many scientific and medical organizations that are coming to us seeking to learn more about this important new approach."