The study will be conducted in the US and Canada and involves about 50 clinical centers. More than 2,000 patients will be included in the study and 1,270 will be treated. The study is expected to be completed during the autumn of 2007. The company’s aim is to achieve FDA approval for market registration at the end of 2008.
The study is designed to have prevention of ulcerative lesions as primary endpoint. Present medications have not been able to show such a beneficial effect in phase III studies and Lipsovir could offer patients a unique treatment opportunity.
“It’s unique that a Swedish biotech company initiates phase III studies in their own regime. If we succeed in taking Lipsovir the whole way to registration it would be a milestone not just for Medivir but also for the whole sector,” commented Medivir’s CEO, Lars Adlersson.