Breast
Phase II Study Begins with ABRAXANE(TM) as Adjuvant Therapy in Early Stage Breast Cancer
By American Pharmaceutical Partners, Inc.
May 4, 2005, 10:47

American Pharmaceutical Partners, Inc. (APP) (Nasdaq: APPX - News) and American BioScience, Inc. (ABI) today announced that patient accrual has been completed in an initial Phase II study of dose dense ABRAXANE(TM) administered as adjuvant therapy following Adriamycin� [A] plus Cytoxan� [C] in early stage breast cancer.

Adjuvant treatment is given after primary therapy (often surgery) to kill any microscopic deposits of cancer cells that may have spread. Studies have shown that adjuvant therapy of AC followed by paclitaxel for breast cancer increases the chance of long-term survival by preventing recurrence and that giving treatment every two weeks (i.e., dose dense) versus every three weeks also may be beneficial.

This open-label initial Phase II study is being conducted by U.S. Oncology (USO), the nation's leading healthcare services network dedicated exclusively to cancer treatment and research, and is being led by principal investigator Nicholas Robert, M.D. of the Fairfax-Northern Virginia Hematology-Oncology Association, Fairfax, VA.

The study's primary goal is to evaluate the safety of Adriamycin plus Cytoxan administered every two weeks for four cycles, the most commonly used regimen in the adjuvant treatment of breast cancer, followed by 260 mg/m2 of ABRAXANE administered in a dose dense regimen, every two weeks for four cycles.

In light of recent findings which demonstrated that Herceptin� plus chemotherapy (combination of AC followed by paclitaxel) improved disease-free survival and overall survival in the adjuvant setting, combination therapy of AC with ABRAXANE, in addition to a dose dense regimen, as well as the inclusion of Herceptin for HER2-positive patients, forms the basis for a pivotal Phase III study in the adjuvant setting to examine the important role ABRAXANE may play.

Dr. Robert said, "This Phase II study is designed to gather safety data in preparation for a large randomized Phase III clinical trial. We are excited about studying ABRAXANE in the adjuvant setting, particularly since it has demonstrated significantly greater antitumor activity than Taxol� in the metastatic setting."

"Based upon its advantageous toxicity and safety profile, we feel that ABRAXANE is an attractive agent to incorporate into dose dense regimens. We are therefore rapidly moving to evaluate ABRAXANE in this setting," said Michael Hawkins, M.D., Chief Medical Officer, of American BioScience.

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