Alvine Initiates Recruitment for Phase 2a Clinical Trial of ALV003 Intended for the Treatment of Celiac Disease.
SAN CARLOS, Calif., August 25, 2009 – Alvine Pharmaceuticals, Inc. announces that patient enrollment has begun for Phase 2a of the randomized, double-blind, placebo-controlled study to confirm safety and efficacy of ALV003 in the treatment of celiac disease (CD).
“The start of this Phase 2a is an exciting step in the clinical development of ALV003 as a potential treatment option for patients with CD,” said Daniel C. Adelman, MD., senior vice president of development and chief medical officer. at Alvin’s.
The objective of this study is to confirm the potential of ALV003 for the benefit of patients, to gather data on its safety when it is taken in repeated doses and also to prepare the Phases 2b and 3 of the study. Approximately 110 patients with well-controlled CD will be randomly selected to receive either a daily dose of ALV003 or placebo for a duration of 6 weeks with a follow-up period of 28 days after the end of treatment.
“This study is designed to confirm the ability of ALV003 to prevent damage to the intestinal mucosa caused by inadvertent gluten ingestion as part of a gluten-free diet, by evaluating changes in histology, serology and We expect this trial to provide us with important information about the safety and potential efficacy of ALV003,” said Dr. Adelman. Results are expected in the second half of 2010.
“The only option for celiacs today is strict adherence to a gluten-free diet, which does not completely eliminate symptoms and complications. We are confident that ALV003 will demonstrate significant potential to improve the lives of patients with of CD,” says Dr Markku Mäki, Professor of Pediatrics at the University of Tampere, Tampere, Finland.