Boeh Mannheim Starts Anti-HBV Trials
Boehringer Mannheim has begun a multinational Phase II trial of Protein Design Labs' human anti-hepatitis B virus antibody, in patients with chronic HBV infection. The study is expected to enroll 200 patients in the USA, France, Germany, UK, Italy, the Netherlands and Israel.
The study will evaluate the product as a single-agent therapy and in combination with interferon alpha, the only approved treatment for the condition in the USA and Europe. It will include patients who are IFN alpha-naive, as well as those who have been treated but did not respond. Boehringer said that it also expects to begin a trial in Asia in 1997.
The PDL antibody binds to a protein on the surface of HBV which is central to the virus' ability to infect hepatocytes. The company has licensed non-US marketing rights to Boehringer, but retains marketing rights in the USA, subject to certain copromotion rights with Sandoz.
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