DIAMYD MEDICAL TO BEGIN REGISTRATION TRIALS OF DIABETES DRUG

Diamyd Medical has announced details of its Phase III clinical protocol for Diamyd, the company's lead drug candidate for the treatment of autoimmune diabetes, Type 1 diabetes and latent autoimmune diabetes of adults (LADA). Based on the results of prior clinical trials in Type 1 diabetes and LADA in Europe, as well as communications from the FDA, the company anticipates that a Phase III trial in the U.S. and a second Phase III trial in Europe will be suitable for product approval to treat Type 1 diabetes.

The U.S. and European arms of the Phase III program would each be multicenter, double-blind, placebo-controlled studies and would each enroll approximately 300 Type 1 diabetes patients within three months of diagnosis. Measured levels of meal-stimulated C-Peptide as a direct marker of endogenous insulin production will be the primary endpoint. Evidence of benefit for insulin requirements and glycemic endpoints will also be evaluated. Results will be evaluated after 15 months, with the patients then continuing to be followed for an additional 15 months.

"The Phase II study that was reported last August showed that only a total of two injections 30 days apart significantly preserved endogenous insulin production as compared to placebo," Anders Essen-Moller, president and CEO of Diamyd Medical, said. "This may make the disease so much easier to handle and is critical to delaying or even avoiding many of the serious problems associated with long-term diabetes."