Diamyd reports successes in Q4
In her comments in today’s year-end report, Elisabeth Lindner, President and CEO of Diamyd Medical, reports that in the last year Diamyd has come ever closer to realizing its vision of being able to prevent and cure the autoimmune form of diabetes in the future.
The most recent quarter has seen significant success in the American Phase III study of the Diamyd® diabetes vaccine, since the US FDA approved the inclusion of children aged 10 and above. The number of clinics in the US will now be gradually tripled to over forty, and an agreement has been signed with patient recruitment firm Inclinix Inc. to accelerate the recruitment of patients. The long-term follow-up of the company’s Phase II study in children and adolescents with newly diagnosed type 1 diabetes continues to show positive development, and the European Phase III study is also progressing well. It will be fully recruited in November. – The successes in our clinical trials, taken together with increased interest in our company and the secured financing of our Phase III results position Diamyd as a diabetes company with an exciting future, says Elisabeth Lindner, President and CEO of Diamyd Medical. During the quarter the first children were also vaccinated in a Swedish prevention study of the Diamyd® diabetes vaccine with the aim of preventing type 1 diabetes. This is the first test ever of preventive vaccination with Diamyd® for this chronic disease. After the end of the reporting period Diamyd resolved to implement a fully underwritten new share issue of just under MSEK 220 with preferential rights for existing shareholders. The last day to subscribe is October 30, 2009. The company has also, after the end of the reporting period, executed a settlement agreement with Apoteket AB regarding a clinical study in LADA patients, which was invalidated in 2007. Diamyd has claimed damages from Apoteket AB for unnecessary costs related to the invalidated study. The settlement agreement includes a payment of SEK 11 million to Diamyd as compensation for the insufficiencies in Apoteket's routines and documentation causing Diamyd to invalidate the study.