Nabi receives fast track designation for Civacir

By Lisa Kerner

Erie, Pa., Feb. 2 - Nabi Biopharmaceuticals said its product candidate Civacir [hepatitis C Immune Globulin (Human)], an antibody for preventing hepatitis C virus re-infection in liver transplants, has been granted fast track designation by the Food and Drug Administration.

Fast track regulations facilitate the development of products that treat serious diseases where an unmet medical need exists and expedites the review process, according to a company news release.

Nabi believes that a proof-of-concept phase 2 trial, followed by a single pivotal phase 3 study, would be adequate for licensure in the United States and Europe, if defined endpoints are met.

The company plans to complete enrollment in the phase 2 study within 12 months, with data available in the second half of 2008. The trial will be designed as a double-blinded, placebo-controlled study in about 100 hepatitis C virus-positive patients, post-liver transplant, with three active dose levels (100, 200 and 400 mg/kg) and 25 patients per group.

Study endpoints are progression of liver fibrosis, liver enzyme levels, and safety and tolerance. The trial will be conducted in the United States and Europe.

In June, Civacir received orphan medicinal product designation for Civacir in Europe. It received U.S. orphan drug status in 2002.

Hepatitis C virus is a chronic blood-borne infection and a leading cause of end-stage liver disease resulting in liver transplantation. About 6,000 liver transplants are conducted annually in the United States.

Nabi Biopharmaceuticals markets products that fight serious medical conditions, including gram-positive bacterial infections, hepatitis, kidney disease (nephrology) and nicotine addiction. The company is based in Rockville, Md.

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