Peregrine Pharmaceuticals, Inc. has announced that it has received clearance from the FDA for its Tarvacin™ anti-viral Investigational New Drug application (IND). The initial clinical protocol under this IND is a phase 1 dose escalation study designed to evaluate a single intravenous infusion of Tarvacin™ in up to 32 patients with chronic Hepatitis C virus (HCV) infection.
“We are excited to begin exploring another clinical indication for Tarvacin™,” said Joseph Shan, senior director of clinical and regulatory affairs. “We anticipate this study will accrue patients rapidly due to the prevalence of chronic Hepatitis C infections in the U.S. and the need for new therapies to treat this disease.”The objectives of the phase 1 clinical protocol are to evaluate safety, pharmacokinetics and viral load in patients chronically infected with 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 U.S. and 170 million people worldwide with chronic HCV infection, which is the most common chronic bloodborne infection in the United States and the leading indication for liver transplantation. There is no known vaccine against HCV.