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"We are eager to start this study and to be able to offer this promisingdrug to our newly diagnosed type 1 diabetes patients", says Professor JerryPalmer, University of Washington in Seattle, USA, who will be the LeadInvestigator for the US study.
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"We are extremely pleased with this progress," says Elisabeth Lindner,President and CEO of Diamyd Medical. "Over the past months we have receiveddozens of patient inquiries with requests to participate in our Phase IIItype 1 diabetes studies in the US and in Europe. It is very satisfying to beable to start the studies now."
The US Phase III study will enroll 306 new-onset type 1 diabetespatients, who are within 3 months of diagnosis. Results of the study will beanalyzed 15 months after all patients have been enrolled. A parallel PhaseIII study is planned to be conducted in Europe and together, pending apositive outcome of the trials, these pivotal studies can be used for marketregistration 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 capacityfor at least 30 months. No safety concerns have to date been reported in anyclinical study with Diamyd(R).
Company website: http://www.diamyd.com
Diamyd Medical AB (publ). Linnegatan 89 B, SE-115 23 Stockholm, Sweden
Disclaimer: This document contains certain statements relating to theprogress, timing and completion of our research, development and clinicaltrials. These statements can be affected by inaccurate assumptions or byknown or unknown risks and uncertainties. Diamyd Medical undertakes noobligation to publicly update such statements, whether because of newinformation, future events or otherwise, nor does Diamyd Medical give anyguarantees that the statements, given or implied, are correct. This documentis a translation from the Swedish original. No guarantees are made that thetranslation is free from errors.
SOURCE Diamyd Medical AB (publ)
