President and CEO Elisabeth Lindner comments on the second quarter
Today the President and CEO of Diamyd Medical commented in the company’s semi-annual report on the steady flow of good news that the company has reported during the quarter, concerning five simultaneous trials in a total of ten countries. After the reporting period the company received a capital injection of MSEK 28, through subscriptions for new shares upon exercise of subscription warrant DIAM TO 2B.
Diamyd Medical is pursuing its product strategy: treat, prevent and cure - We continue to work diligently on treating, preventing and now also curing type 1 diabetes, three strategies that are complementary from a life cycle perspective, and which are of great importance for the company’s long-term development, says Diamyd Medical President and CEO Elisabeth Lindner. The European Phase III trial has been approved in large countries such as Germany, France and Italy, speeding the rate of patient recruitment. Two separate investigator initiated prevention studies, have been approved by the regulatory agencies in Sweden and Norway. The studies’ objectives are to investigate the disease process of type 1 diabetes and to prevent the disease in people at high risk of developing type 1 diabetes. During the period the FDA also approved a combination study where the Diamyd® vaccine is evaluated in combination with medication considered to stimulate the growth of new insulin-producing beta cells. This study means that in addition to treating and preventing diabetes, Diamyd Medical is now also evaluating the vaccine’s potential to cure the disease. The European Phase III trial, where the Diamyd® vaccine is being tested in children and adolescents with recent-onset type 1 diabetes, has now been approved in all nine European countries where applications were submitted. At the same time, Diamyd Medical is holding discussions with the regulatory agencies about combining the American and European Phase III trials into one global trial, with the objective of reducing costs and utilizing the countries with the fastest rate of patient recruitment to the greatest extent. During the second quarter Diamyd Medical also received approval from the Swedish Medical Products Agency to continue following the children with type 1 diabetes who were vaccinated with Diamyd® four years ago, with the objective of confirming the long-term efficacy of the Diamyd® vaccine.
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