Tarvacin
New data support broad anti-viral potential of Tarvacin(TM)
By Peregrine Pharmaceuticals, Inc.
Aug 1, 2005, 00:00

Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), has presented new data at the Biotechnology Industry Organization 2005 (BIO 2005) annual meeting in Philadelphia, PA. supporting the broad anti-viral potential of Tarvacin(TM). The data presented at BIO 2005 showed that Tarvacin(TM) binds to enveloped virus particles representing 6 different virus families, binds to virally infected cells and inhibits viral replication in multiple virus systems. The data also indicated that Tarvacin(TM) provided significant protection against Cytomegalovirus (CMV) and Pichinde virus (an in vivo Lassa fever model) infections.

Data presented at the conference demonstrated:

Tarvacin(TM) binds to viruses from six different enveloped virus families, including specific binding to HIV 1 and 2, Influenza A and B, Measles, Respiratory Syncitial Virus (RSV), Bovine Viral Diarrhea (a surrogate in vitro Hepatitis C virus model), and Pichinde virus.
Tarvacin(TM) binds to cells infected with Influenza, Vaccinia (a model for Smallpox) and Pichinde viruses.
Anti-Phosphatidylserine antibodies inhibited replication of RSV, Vesicular Stomatitis Virus and Pichinde viruses.
Anti-Phosphatidylserine antibodies provided significant protection in animals infected with cytomegalovirus (CMV) with 100% of the Anti- Phosphatidylserine antibodies treated animals surviving and only 20% of animals receiving control treatment surviving.

Tarvacin(TM) provided significant protection in animals administered lethal viral loads of Pichinde virus (a model of Lassa fever) with 50% of the Tarvacin(TM) treated animals surviving and none of the animals receiving control treatment surviving.

Animals lethally infected with Pichinde virus that survived following Tarvacin(TM) therapy had long term immunity to reinfection.

"These data further illustrate why we are excited about the Tarvacin(TM) anti-viral program," stated Steven King, president and CEO of Peregrine. "We are looking forward to initiating the Tarvacin(TM) Hepatitis C clinical trial, continuing our collaboration with National Institute of Allergy and Infectious Diseases (NIAID) and expanding into other collaborations to further explore the potential of the program for the treatment of viral infections."

Peregrine received FDA approval to begin a Tarvacin(TM) phase I clinical trial in Hepatitis C infected patients in late May 2005. In April of 2005, Peregrine and the National Institute of Allergy and Infectious Diseases (NIAID) entered into a collaborative effort to screen Tarvacin(TM) for activity both in vitro and in vivo against a wide variety of enveloped viruses of health and bioterrorism concern including Hepatitis C, influenza and SARS. Peregrine is continuing to evaluate Tarvacin(TM) for the treatment of a variety of viral infections that could lead to additional therapeutic indications in this area. In addition, Peregrine is currently recruiting patients in a Tarvacin(TM) phase I clinical trial that is open to patients with advanced solid tumor cancer.

About Tarvacin(TM)

Anti-Phospholipid Therapy is Peregrine's novel approach to treating cancer, viral infections and certain other diseases. It is based on the finding that aminophospholipids, which are basic components of the inner surface of the cellular membrane, become exposed in certain disease states. Tarvacin(TM) is a chimeric monoclonal antibody that binds to the phospholipid, phosphatidylserine, and is part of Peregrine's Anti-Phospholipid Therapy platform. Tarvacin(TM) binds directly to tumor blood vessels to inhibit growth and development of solid tumors. Tarvacin(TM) has also shown promise in the treatment of viral infections and is expected to recognize a broad spectrum of enveloped viral types. Tarvacin(TM) is currently being evaluated for the treatment of both cancer and viral diseases. Peregrine has received FDA approval to initiate two separate Phase 1 clinical trials in advanced solid cancer and chronic Hepatitis C virus indications.

About Enveloped Viruses

A large number of viruses significant to global health and security possess an "envelope" derived from their host cell membrane. The outer shell of the virus is known as the viral envelope. Since viruses lack the means to maintain structural organization of the envelope, amino-phospholipids such as phosphatidylserine (PS) and phosphatidylethanolamine (PE) become exposed on the surface of these viruses, making them a potential therapeutic target. Peregrine Pharmaceuticals, together with its collaborators, has developed a series of monoclonal antibodies, including Tarvacin(TM), directed against aminophospholipids to take advantage of this property.

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