Peregrine completes enrollment, dosing in Tarvacin hepatitis C trial

By E. Janene Geiss

Philadelphia, Feb. 15 - Peregrine Pharmaceuticals, Inc. announced Wednesday that it has completed planned patient enrollment and dosing in its initial phase l clinical trial for Tarvacin antiviral in the treatment of chronic hepatitis C virus infection.

The single-dose ascending trial was conducted in patients with chronic hepatitis C virus who have either failed or no longer respond to standard-of-care treatment, according to a company news release.

Findings are expected to support the start of repeat dose and combination therapy trials later this year, officials said.

Top-line safety data from the study will be presented at the Viral Hepatitis in Drug Discovery and Development meeting to be held in Boston on Feb. 27, officials said.

Tarvacin antiviral is a monoclonal antibody with unique antiviral properties that is in preclinical studies for pandemic and seasonal influenza, cytomegalovirus, HIV and biodefense applications.

Tarvacin also is in phase l clinical trials for the treatment of advanced refractory solid cancers.

"Completing this first [hepatitis C] study of Tarvacin antiviral ahead of schedule is enabling us to accelerate plans for future clinical studies and for new collaborations with clinical sites," said Steven W. King, president and chief executive officer of Peregrine, in the release.

"Since a first-cut analysis of the study data suggests that Tarvacin antiviral appears to be well-tolerated in these patients, we are considering adding additional patients to the protocol at an ascending dose while advancing plans for the next round of clinical studies," King added.

Tarvacin is a monoclonal antibody that attaches to specific cellular components called phospholipids found on the surface of virus particles, including influenza and certain other virus strains, as well as on the outer surface of human host cells only when they are infected with these viruses.

Tarvacin helps stimulate the body's natural immune defenses to destroy both the virus particles and the infected cells, officials said.

Since the targeted phospholipids are not exposed on healthy cells, they are not affected by Tarvacin, which in studies to date appears to be safe and well-tolerated, officials said.

Peregrine is a Tustin, Calif., biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and viral diseases.

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