Acusphere completes enrollment in phase 3 AI-700 clinical trial

By Elaine Rigoli

Tampa, Fla., March 7 - Acusphere, Inc. announced that it has closed enrollment in its "32" trial, one of two phase 3 clinical trials for AI-700, and anticipates making a public announcement about the data before the end of the second-quarter 2006.

Based on estimates from previous clinical trials for AI-700, Acusphere said it has enrolled enough patients in both the 32 and 33 trials to be able to achieve statistical significance in both of these trials.

Acusphere said that continuing to enroll patients in the 33 trial should increase the probability of success of this trial without delaying the New Drug Application filing date.

Therefore, the company also said it plans to continue to enroll patients in its 33 trial through the end of the second quarter and anticipates making a public announcement about the data from this trial during the fourth-quarter 2006, according to a company news release.

Completing the qualification of the company's commercial manufacturing facility is on the critical path to an NDA filing for AI-700, which is expected during the first half of 2007, the release said.

As announced in December, Acusphere suspended enrollment in the 32 trial on the premise that enough patients had been enrolled to be able to achieve statistical significance in that trial. As a result, the required 90-day follow-up period on all patients enrolled is now nearly complete, the release said.

Acusphere said it is working to ensure that the blinded reads are completed on all patients enrolled in this trial and that all data are properly collected.

Acusphere had previously announced that it would conduct a sample size re-estimation (SSRE) through an independent data monitoring board as a way to confirm the sample size for each trial.

After further discussion with statistical and regulatory consultants during the first quarter of 2006, the company has decided not to do a SSRE and is instead relying on its statistical modeling and quantitative methods, which the company believes has advantages over the SSRE, the release said.

Acusphere, located in Watertown, Mass., is a pharmaceutical company that develops new drugs and improved formulations of existing drugs using its proprietary microparticle technology.

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