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Posts with tag PhaseIi

A diamond in the rough to cure diabetes

Diamyd Medical's flagship drug, Diamyd, is showing promising results in reducing the need of insulin injections and preventing the destruction of beta cells.

Diamyd has demonstrated significant efficacy in preserving insulin production in 70 children and adolescents with type 1 diabetes. No serious adverse events associated with the therapy were observed. The results from the Diamyd study demonstrate that the group of 35 recently diagnosed type 1 diabetes patients that received Diamyd produced approximately twice as much meal stimulated insulin (as measured by C-peptide) 15 months after the first treatment as compared to the placebo group. Preserving insulin-production is crucial for delaying the complications associated with long-term diabetes which cost billions of dollars to treat. Furthermore, it may allow for regeneration of beta cells in a non-autoimmune environment, thus setting the stage for a cure of the disease.

"We look forward to opening the dialog with the FDA regarding the potential initiation of our clinical program for Diamyd in the US" says Anders Essen-Möller, CEO of Diamyd Medical. "We obviously cannot predict the outcome of any meeting with the regulatory authorities, but we hope we will gain some valuable guidance towards structuring a suitable US clinical program for the continued development of Diamyd as a therapy for type 1 diabetes." Anders-you let me know if the regulatory authorities give you any funny business. I'll see what the diabetic community has to say about it. The buck stops here!

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