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Diamyd Gets Authorization to Begin Phase III Study in the US

STOCKHOLM, March 14 /PRNewswire-FirstCall/ -- Diamyd Medical AB (, ticker: DIAM B;, ticker DMYDY). The FDA has given Diamyd Medical permission to start a Phase III clinical study in type 1 diabetes patients in the US with the therapeutic diabetes vaccine Diamyd(R).

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"We are eager to start this study and to be able to offer this promising drug to our newly diagnosed type 1 diabetes patients", says Professor Jerry Palmer, University of Washington in Seattle, USA, who will be the Lead Investigator for the US study.

"We are extremely pleased with this progress," says Elisabeth Lindner, President and CEO of Diamyd Medical. "Over the past months we have received dozens of patient inquiries with requests to participate in our Phase III type 1 diabetes studies in the US and in Europe. It is very satisfying to be able to start the studies now."

The US Phase III study will enroll 306 new-onset type 1 diabetes patients, who are within 3 months of diagnosis. Results of the study will be analyzed 15 months after all patients have been enrolled. A parallel Phase III study is planned to be conducted in Europe and together, pending a positive outcome of the trials, these pivotal studies can be used for market registration of the drug.

In a previous Phase II study in young type 1 diabetes patients, Diamyd(R) 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(R).

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Diamyd Medical AB (publ). Linnegatan 89 B, SE-115 23 Stockholm, Sweden

Disclaimer: This document contains certain statements relating to the progress, timing and completion of our research, development and clinical trials. These statements can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Diamyd Medical undertakes no obligation to publicly update such statements, whether because of new information, future events or otherwise, nor does Diamyd Medical give any guarantees that the statements, given or implied, are correct. This document is a translation from the Swedish original. No guarantees are made that the translation is free from errors.

SOURCE Diamyd Medical AB (publ)
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