American Pharmaceutical, American BioScience's Abraxane shows better response for cancer than Taxol

By Angela McDaniels

Seattle, Nov. 1 - American Pharmaceutical Partners Inc. and American BioScience Inc. said that data from the phase-3 clinical trial of Abraxane shows the drug almost doubled the response rate in patients with metastatic breast cancer compared with Taxol and prolonged the time to tumor progression by more than a third.

There was also a statistically significant prolongation in median survival by over two months in patients who received Abraxane as second-line or greater therapy, compared with Taxol, the companies said.

The data was detailed in a paper titled, "Superior Efficacy of Albumin-Bound Paclitaxel, ABI-007, Compared With Polyethylated Castor Oil-Based Paclitaxel in Women With Metastatic Breast Cancer," published in the Journal of Clinical Oncology.

The paper was also released online on Sept. 19. The companies said the journal publishes articles early when they may be expected to have a substantial and immediate impact on clinical practice.

An additional phase-1 study of Abraxane in the treatment of advanced cancer was carried out to determine the safety and maximum tolerated dose of Abraxane when administered weekly. It too found advantages of Abraxane over Taxol, the companies said, though the effective dose of Abraxane was found to be approximately 50% higher than that typically used for Taxol when given weekly.

The U.S. Food and Drug Administration approved Abraxane (formerly ABI-007) in January 2005 for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

American Pharmaceutical Partners is a drug company based in Schaumburg, Ill., that develops injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.

American BioScience is a biotechnology company based in Santa Monica, Calif., that develops therapies for the treatment of life-threatening diseases. The company owns a majority interest in American Pharmaceutical Partners.

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