Boston Life Sciences: new SPA for Altropane

USA-based Boston Life Sciences says that the US Food and Drug Administration has granted a new Special Protocol Assessment for Altropane, its molecular imaging agent in development to help differentiate Parkinsonian syndrome tremor from non-Parkinsonian tremor. Under the agreement with the FDA, the group will carry out two smaller Phase III trials, POET-1 and POET-2, as opposed to the originally-planned single large Phase III trial, without sacrificing its SPA status. The company has reduced its statistical endpoint threshold from p<0.02 to p<0.05 for both studies.

Boston Life Sciences president Mark Pykett commented: "we believe this new agreement with the FDA is beneficial in three ways. First and foremost, we significantly lowered our statistical endpoint requirement from p<0.02 to p<0.05. Second, we retained our SPA status without losing the benefit of the patients that have been enrolled to date. Third, we abbreviated the time and cost of completing the ongoing Phase III study. As a result, we may be in a position to advance partnering opportunities earlier than expected."