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Phase 2 Trial Will Examine Abraxane in Combination With Herceptin

SCHAUMBURG, Ill., April 4 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (NASDAQ:APPX) today announced that American BioScience, Inc. has initiated enrollment in a Phase II study of Abraxane administered weekly in combination with Herceptin in first-line treatment of metastatic breast cancer. The study will be conducted by International Oncology Network (ION), the nation's premier, and largest, network of community-based oncologists and will include 20 ION sites.

The open-label, non-randomized study will include 70 patients with locally advanced or metastatic breast cancer and will be led by principal investigator Barry C. Mirtsching, M.D., Director of the Center for Oncology Research & Treatment, Medical City Dallas Hospital, Dallas, TX. All patients will receive Abraxane at a dose of 125mg/m2 by a 30-minute IV infusion once a week for weeks 1-3 in each 4-week cycle of treatment; the HER2-positive patients will, in addition, receive Herceptin, which is regularly used in the treatment of these patients. The primary study endpoint is response rate (RR) and the secondary study endpoints are time to tumor progression (TTP), overall survival (OS) and toxicities. Approximately 30% of all metastatic breast cancer patients are HER2-positive.

Dr. Mirtsching said, "We look forward to studying Abraxane in previously untreated metastatic breast cancer patients, using a weekly dosing regimen, and combining it with Herceptin in HER2-positive patients."

Jeffrey Scott, M.D., president and national medical director of ION, said, "Abraxane has demonstrated superiority over Taxol in terms of response rate, time to tumor progression and survival. The combination of Abraxane with Herceptin in the absence of steroid premedication is an important addition to the armamentarium that oncologists use to treat patients with breast cancer."

Abraxane was launched on February 7, 2005 by Abraxis Oncology, the proprietary division of APP after having received FDA approval in January. Abraxane is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

Source: American Pharmaceutical Partners, Inc.

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