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Alvine Pharmaceuticals Report - October 29, 2008

Lisa

By Lisa
in Publications & Publicity

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Lisa Mentor
Lisa
Posted

Alvine Pharmaceuticals Reports Positive Results with ALV003 in Phase 1 Trial of Therapy in Development for Celiac Disease

SAN CARLOS, Calif., October 29, 2008 - Alvine Pharmaceuticals, Inc., today announced proof of concept in a Phase 1 Trial of ALV003, an oral protease therapy in development to detoxify gluten, intended for use by patients with celiac disease. The trial results confirmed that single doses of up to 1,800 mg of ALV003 were safe and tolerable in healthy volunteers. Doses at the 300 mg level achieved up to a 96% reduction of gluten in a meal in the stomach at 30 minutes, and were well tolerated by patients with celiac disease. In addition, doses as low as 100 mg were shown to be biologically active in degrading gluten in the stomach. Based on these results, Alvine plans to initiate Phase 1/2a multidose trials in early 2009.

"The outcome of the Phase 1 Trial of ALV003 is a major step toward providing people with celiac disease a better quality of life, as there are currently no approved pharmaceutical therapies available," said Dr. Ciar

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