8 August, 2005: Nasdaq-listed Peregrine Pharmaceuticals, Inc. has announced start of a phase I anti-viral study of Tarvacin, the firm’s first Anti-Phospholipid Therapy candidate.
The phase I study is an open-label, dose-escalation study in up to 32 adult patients with chronic hepatitis C virus (HCV) infection who either no longer respond to or failed standard therapy with pegylated interferon and ribavirin combination therapy.
The study, which aims to evaluate safety, pharmacokinetics and viral load following a single intravenous infusion, is being conducted at Bach and Godofsky Infectious Diseases, the largest private infectious disease practice specializing in the treatment of viral hepatitis in the US.
"Tarvacin is truly a novel approach to treating HCV and we are eager to offer patients the opportunity to participate in this trial," stated Eliot W. Godofsky, M.D., Principal Investigator and clinical assistant professor of medicine at the University of Sout Florida in Tampa.
"This study is an important step for our Tarvacin(TM) antiviral program," said Joseph Shan, Peregrine's senior director of clinical and regulatory affairs. "Meanwhile, we are continuing our Tarvacin(TM) development efforts for other viral diseases."
Hepatitis C is an infection of the liver that is caused by an RNA virus. It is transmitted primarily by blood as in blood transfusions or intravenous drug use and sometimes through sexual contact. Most cases of non-A, non-B hepatitis are of this type.
The hepatitis C virus (HCV) is one of the most serious ailments affecting the liver. A estimated 4 million Americans and 170 million people worldwide have been affected with the disease.
The prevalence of hepatitis C virus infections in Scandinavia is less than 0.5% of the population, while in Egypt it is over 20%. In the U.S. and Western Europe, the complications of hepatitis C virus chronic hepatitis and cirrhosis are the most common reasons for liver transplantation.
Peregrine Pharmaceuticals is also developing Vascular Targeting Agents, Anti-Angiogenesis, and Vasopermeation Enhancement Agents (VEAs) for the treatment of cancer and other diseases.
BY OUR PHARMA CORRESPONDENT