Acusphere Expands AI-700 Phase III Trials

Acusphere has met with various representatives of the Division of Medical Imaging and Radiopharmaceuticals at the FDA to discuss clinical trials progress and a potential new drug application (NDA) for AI-700, leading to a revision of the company's statistical analysis plan.

The purpose of this meeting was to discuss the rationale behind the Phase III clinical design and statistical analysis plan with new members of the division, particularly the new division head, who were not involved in these discussions before the start of Phase III pivotal trials, and to receive their feedback.

Based on the feedback, Acusphere has revised its statistical analysis plan. These revisions require Phase III pivotal trial enrollment of approximately 700 patients rather than 600 as had been previously estimated. The company has enrolled more than 350 patients in the Phase III pivotal trials to date and that the rate of enrollment in these trials has been averaging approximately 50 patients per month.

If this rate of enrollment continues, it should be possible to complete enrollment of 700 patients by the end of 2005. However, Acusphere management believes that enrollment rates may be variable, particularly during the summer and holiday months, and, therefore, has decided to change its guidance for completing enrollment to early 2006, rather than by the end of 2005, as had been previously estimated. The company confirmed its previously stated guidance that it expects to be in a position to file the AI-700 NDA in 2006.