NABI BEGINS TRIAL OF HCV ANTIBODY

Nabi Biopharmaceuticals has initiated its Phase II proof-of-concept clinical trial for Civacir (hepatitis C immune globulin (Human)). Civacir, the company's plasma-derived, polyclonal antibody product candidate, if approved, would be the first therapy for the prevention of the recurrence of hepatitis C-related liver disease in liver transplant recipients with hepatitis C virus (HCV) infection, or in patients who received an HCV-positive liver. Currently, there are no marketed therapies specifically indicated for prevention of re-infection after liver transplant in HCV-positive patients.

Nabi is co-developing Civacir with Kedrion, which is fully funding the costs of the trials and is also funding some of the costs of manufacturing Civacir for use in the trial. The two companies will pursue a common strategy to develop and commercialize Civacir in Europe and the U.S., with Kedrion being Nabi Biopharmaceuticals' exclusive licensee to commercialize Civacir in Europe. In addition to assuming the majority of the funding for the clinical trials and clinical materials in Europe and the U.S., Kedrion will pay milestone and royalty payments to Nabi.

The trial is a randomized, controlled study involving 30 patients in a 2-1 randomization, with 20 patients allocated to Civacir at a dosage of 400 mg/kg and 10 patients receiving standard-of-care. The primary endpoints are progression of liver fibrosis on biopsies as well as HCV levels in liver and serum. The secondary endpoints include liver enzymes as well as safety and tolerance. The company expects to complete enrollment in the second half of 2007, with the results being announced in the second half of 2008.

Civacir is an investigational human polyclonal antibody product that contains antibodies to HCV. Last year Nabi announced that Civacir had been granted FDA fast-track status. The drug also has orphan drug designation in Europe.