Breast Cancer - Clinical Study of Abraxane

Main Category: Breast Cancer
Article Date: 07 Apr 2005 - 1:00 PDT


American Pharmaceutical Partners Announces Initiation of a Clinical Study of Abraxane in the Most Widely Used Combination Chemotherapy Regimen of Paclitaxel and Herceptin in HER2-Positive Breast Cancer Patients.

- Study to be Conducted by ION, the Largest Network of Community Oncologists

- ABRAXANE to be Administered Weekly in Combination with Herceptin as First-Line Therapy in Metastatic Breast Cancer

American Pharmaceutical Partners, Inc (Nasdaq: APPX) today announced that American BioScience, Inc. has initiated enrollment in a Phase II study of ABRAXANE(TM) 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(R), 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(R) 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(TM) 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.

About International Oncology Network

International Oncology Network (ION) has become the nation's premier -- and largest -- network of community-based oncologists. Members are committed to helping promote quality cancer care where patients need it the most -- close to home -- in their own communities. By bringing clinical research, educational symposia, information systems, and other innovative services to the local oncology community, ION provides tools to physicians that can help maintain a level of expertise so needed in the rapidly changing environment of oncologic treatment options. ION members range from solo practitioners to some of the country's largest and most renowned private practices -- all committed to improving the quality of patient care in their own communities. For more information, visit http://www.iononline.com.

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 http://www.appdrugs.com and http://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.

Herceptin is a registered trademark of Genentech, Inc.
TAXOL is a registered trademark of Bristol-Myers Squibb Company

American Pharmaceutical Partners, Inc.
http://www.appdrugs.com
http://www.abraxisoncology.com

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