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R&D, In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Younger recruitment for Diamyd's type 1 diabetes vaccine trial: Diamyd Medical is now recruiting type 1 diabetes patients aged 10 to 20 for the Phase III trial of the Diamyd diabetes vaccine, the firm announced Aug. 27. When Diamyd filed the IND for the trial, the lower age limit was 16 (1Pharmaceutical Approvals Monthly January 2008). FDA lowered the enrollment age in June to 10 years old, and the firm is now increasing its investment in the development program with more clinics and expanded recruitment activities. It will retain 13 of the original clinics and is aiming to add about 30 more. The vaccine, based on autoantigen GAD65, is designed to slow down autoimmune destruction of insulin-producing beta cells. It already has been shown in Phase II to preserve beta cell function for at least 21 months in patients with recent-onset type 1 diabetes. Other ongoing trials are aimed at better understanding natural production of insulin and the immunological mechanism of action of the vaccine, and studying the disease process of developing type 1 diabetes. The firm aims to gain approval for the vaccine in 2012
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