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Biotech / Medical : Biotech Valuation

CRSP 64.02

+4.7%

3:59 PM EDT

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From: B O Trust	3/14/2008 7:56:48 AM
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undervalued unknown in U.S. with No safety concerns what so ever. The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within 3 months of diagnosis. In one arm of the study, 102 patients will receive a 20 µg injection of Diamyd® on study days 1 and 30 to confirm earlier Phase II results. In a second arm, 102 patients will receive a 20 µg injection of Diamyd® on days 1 and 30, and then additional doses on days 90 and 270 to investigate the potential long-term beneficial effect of extra doses. In the third arm of the study, 102 patients will receive placebo. Results of the study will be analyzed 15 months after all patients have received their 1st injection. A parallel similar Phase III study is planned to be conducted in Europe and together, pending a positive outcome of the trials, the studies can be used for market registration of the drug. In a previous Phase II study in young type 1 diabetes patients, the Diamyd® diabetes vaccine showed efficacy in preserving the patients' own insulin producing capacity for at least 30 months. No safety concerns have to date been reported in any clinical study with Diamyd®. diamyd.com

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