Nabi Biopharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted its investigational product, Civacir [Hepatitis C Immune Globulin (Human)], Orphan Drug Designation for prevention of hepatitis C infection in liver transplant recipients. Civacir is an antibody-based therapy currently in its first clinical trial.
"We are pleased to receive Orphan Drug Designation for Civacir," said David J. Gury, chairman and chief executive officer of Nabi Biopharmaceuticals. "We announced the initiation of our Civacir phase I/II trial in hepatitis C liver transplant patients in April of this year. We have recently completed the patient enrollment phase of this trial and anticipate reporting results during 2003. HCV infection results in five times as many liver transplants as hepatitis B virus infection, and protecting HCV liver transplant patients from re-infection of their transplanted livers represents a significant unmet medical need. If successfully developed and approved by the FDA, Civacir would become the first therapy specifically developed to help protect patients from HCV following liver transplant surgery."
The phase I/II trial of Civacir is a three-armed, randomized, controlled clinical study evaluating two dose levels of Civacir versus a control. This trial is also evaluating the safety and antibody levels of Civacir, as well as its effects on the levels of hepatitis C virus circulating in the patients' blood and in the transplanted livers. Results of a previously reported study in chimpanzees showed that multiple infusions of Civacir effectively eliminated circulating HCV and protected animals against HCV-induced liver disease for as long as antibody levels were maintained.
This Civacir clinical trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, and is being conducted by the NIAID Collaborative Anti-Viral Study Group at five study sites in the United States.
Approximately 4 million people in the U.S. and 175 million people worldwide are infected with HCV. An estimated 85 per cent of acutely infected individuals become chronic carriers of HCV, a condition that can often result in insidiously progressive liver disease. The Centers for Disease Control and Prevention (CDC) report that approximately 5 per cent of those infected with HCV develop liver failure or liver cancer and require a liver transplant in order to survive.
Of the nearly 5,000 liver transplants performed in the U.S. in 1999, approximately 40 percent were due to complications from HCV.