Enrollment for pivotal phase III trial of ABI-007 completed.(American Pharmaceutical Partners Inc. announce trials for nanoparticle paclitaxel for metastatic breast cancer treatment)

2003 JAN 9 - (NewsRx.com & NewsRx.net) -- American Pharmaceutical Partners, Inc., (APPX) announced that patient enrollment has been completed in the pivotal phase III clinical trial evaluating ABI-007, a next generation nanoparticle paclitaxel, in patients with metastatic breast cancer.

A total of 460 patients with first and second line metastatic breast cancer were enrolled in this multicenter trial. This is consistent with the company's previous report in October 2002 stating that the independent Data Monitoring Committee had concluded that the approved clinical trial sample size, which provides for 460 patients, would not need to be augmented to achieve the endpoints in this phase III trial.

"We have achieved an important milestone in the development of this next generation taxane and the completion of this phase III trial marks the culmination of a clinical development plan discussed with FDA since 1996," said Patrick Soon-Shiong, MD, chairman, president, and chief executive officer. "With the conclusion of enrollment, we now are working diligently to collect and analyze the data in preparation for an expected NDA submission by mid-2003."

ABI-007 ...