Phase II Study Begins with ABRAXANE(TM) as Adjuvant Therapy in Early Stage Breast Cancer
May 4, 2005, 10:47, Reviewed by: Dr.
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"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."
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By American Pharmaceutical Partners, Inc.,
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. 
- 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
www.appdrugs.com
About U.S. Oncology
U.S. Oncology (USO) is the nation's largest health-care services network devoted exclusively to cancer treatment and research, and a pioneer in community-based cancer care since 1993. Today, its network of over 850 affiliated physicians delivers care to more than half a million cancer patients each year -- including over 15% of all newly diagnosed U.S. cases.
In fact, USO serves more cancer patients than any other single health-care organization in America.
About American BioScience, Inc.
American BioScience, Inc. (ABI) is a privately held biotechnology company focused on the discovery, development and delivery of next-generation therapeutic moieties including biologically active molecules already existing within the human biological system, for the treatment of life-threatening diseases. ABI owns a majority interest in American Pharmaceutical Partners, Inc. (Nasdaq: APPX - News; APP).
About American Pharmaceutical Partners
American Pharmaceutical Partners, Inc. is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets. Abraxis Oncology, the proprietary division of APP, is devoted entirely to developing and promoting innovative, next-generation cancer therapies such as ABRAXANE(TM), recently launched for the treatment of metastatic breast cancer. For more information, visit APP's website at www.appdrugs.com and www.abraxisoncology.com.
This press release contains forward-looking statements within the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. All statements included or incorporated by reference in this press release, other than statements that are purely historical, are forward-looking statements. The words "may," "will," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "continue," and similar expressions identify forward-looking statements. Forward-looking statements also include the assumptions underlying or relating to any forward-looking statements.
Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, the timing of and costs associated with the ongoing launch of ABRAXANE(TM), the market adoption and demand of ABRAXANE, that the actual results achieved in further Phase II and III trials for ABRAXANE may or may not be consistent with results achieved to date, the difficulty in predicting the timing or outcome of other product research and development efforts, potential product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, the ability to successfully manufacture products in a time-sensitive and cost effective manner, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties. Additional relevant information concerning risks can be found in the Company's Form 10-K for the year ended December 31, 2003 and other documents filed by the Company with the Securities and Exchange Commission.
The forward-looking statements in this press release reflect the Company's judgment as of the date of this press release. The Company disclaims any intent or obligation to update these forward-looking statements.
Cytoxan and Taxol are registered trademarks of Bristol-Myers Squibb Company.
Adriamycin is a registered trademark of Pharmacia.
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