November 6, 2008
Diamyd Medical Wins European Approval for Phase III Diabetes Study
Sweden-based biopharmaceutical company Diamyd Medical has reported that six European countries have approved the initiation of a Phase III study with the Diamyd diabetes vaccine for type 1 diabetes.
The application processes to the national regulatory agencies and ethics committees have proceeded according to plan, and the company has now received agency approvals for a European Phase III study of children and adolescents with type 1 diabetes in the Netherlands, UK, Finland, Slovenia, Spain and Sweden.
Diamyd Medical is conducting two clinical Phase III studies with the Diamyd diabetes vaccine for type 1 diabetes, one in Europe and the other in the US. The studies apply to people recently diagnosed with type 1 diabetes, ie, within the last three months.
Furthermore, the company has initiated clinical studies within chronic pain, using its nerve targeting drug delivery system. The company has also out-licensed the use of GAD for the treatment of Parkinson's disease.
Elisabeth Lindner, president and CEO of Diamyd Medical, said: "The fact that Diamyd successfully pursues a project as large as its Phase III program on its own with limited resources demonstrates that we have an extremely competent and committed organization. We have met all of this year's intermediate goals on time, and we are continuing our strategy of building a market-oriented pharmaceutical company in the area of diabetes."