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news.Peregrine Pharmaceuticals has received clearance from the FDA for its Tarvacin anti-viral Investigational New Drug application. The initial clinical protocol under this IND is a phase I dose escalation study designed to evaluate a single intravenous infusion of Tarvacin in up to 32 patients with chronic hepatitis C virus infection.
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The objectives of the phase I clinical protocol are to evaluate safety, pharmacokinetics and viral load in patients chronically infected with Hepatitis C virus (HCV) who have failed to respond or who have relapsed after the current standard treatment with pegylated interferon plus ribavirin. Up to 50% of patients receiving the combination of pegylated interferon plus ribavirin either relapse or do not respond after treatment.
“Receiving clearance to begin this initial Tarvacin anti-viral clinical trial is an important milestone for the program,” stated Steven King, president and CEO. “We are continuing to evaluate Tarvacin’s potential for the treatment of other enveloped virus infections, including HIV, influenza A, influenza B, avian flu, as well as viruses included on the government’s bioterrorism watchlist such as Lassa fever and Marburg virus.”
According to the World Health Organization, there are an estimated 2.7 million people in the US and 170 million people worldwide with chronic HCV infection, which is the most common chronic bloodborne infection in the US and the leading indication for liver transplantation. There is no known vaccine against HCV.