2007-03-08 12:59
- Biotech Sweden:
Diamyd proceeds with Phase III trial
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Diamyd Medical has announced details for its Phase III clinical trial in type-1 diabetes with its lead candidate Diamyd. It plans a Phase III trial in the US and a second Phase III trial which will run in parallel in Europe. It will take around nine months to recruit the 600 patients at the 30 chosen sites across Europe and the US.
Both trials will be multi-center, double-blind, placebo-controlled and will involve 600 type-1Diabetic patients who have been diagnosed within a three-month-period.
It will take around nine months to enroll the patients in the 30 chosen sites across the US and Europe. The results will be evaluated after 15 months and then the patients will be followed for an additional 15 months.
Anders Essen-Möller, president and CEO of Diamyd Medical said, “We are pleased with the conversations we have had with more than 40 potential clinical trial sites in several European countries. If everything goes as planned - there are still some technical outstanding matters to address that regards manufacturing - applications to start the trials will be submitted to the regulatory authorities so that recruitment of patients can start before year end.”