Healthcare Industry News: paclitaxel
News Release - December 11, 2006
Abraxis BioScience to Present Data from Six Studies at San Antonio Breast Cancer SymposiumOral Presentation of Interim Analysis of Randomized, Head-to-Head Phase II Study of ABRAXANE Versus Taxotere In First-line Metastatic Breast Cancer
Poster Presentations Highlight Treatment of Breast Cancer with ABRAXANE in Various Settings and Dose Regimens
LOS ANGELES--(HSMN NewsFeed)--Abraxis BioScience, Inc. (NASDAQ:ABBI ), an integrated, global biopharmaceutical company, announced today that one oral and five poster presentations of ABRAXANEŽ for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) will be presented at the 29th Annual San Antonio Breast Cancer Symposium, December 14 - 17, 2006. The studies to be presented are intended to highlight the clinical benefits of ABRAXANE in the treatment of breast cancer. In the oral presentation, interim data will be discussed from a 300 patient, randomized, Phase II head-to-head trial of ABRAXANE versus TaxotereŽ (docetaxel) in the first-line treatment of metastatic breast cancer.
The Phase II ABRAXANE study (Abstract Number 46: A Randomized Phase 2 Trial of qW or q3W ABI-007 (ABX) vs. q3W Solvent-Based Docetaxel (TXT) as First-line Therapy in Metastatic Breast Cancer (MBC)) was designed to examine first-line treatment with various doses of ABRAXANE given weekly and every three weeks compared to Taxotere dosed every three weeks in patients with metastatic breast cancer. In the trial, first-line treatment with weekly ABRAXANE compared to every three week ABRAXANE was also studied. The primary endpoints of the study are comparative toxicity and anti-tumor response, with a secondary endpoint of progression-free survival. The interim results will be presented orally on December 17, 2006 at 10:45 a.m. CST in Ballroom B by William Gradishar, M.D. of Northwestern University, the lead investigator on the study.
Additional ABRAXANEŽ Posters Presentations
December 14, 2006, 5:00 p.m.-7:00 p.m., Treatment: Chemotherapy - New Drugs and Formulations (Session 1) Synergistic effect of albumin-bound paclitaxel (Abraxane) and Anti-VEGF-a antibody (Avastin) on growth of orthotopic MDA-MB-231 breast tumors as well as lymphatic and pulmonary metastases (Poster Number: 1094)
December 14, 2006, Treatment: Chemotherapy - New Drugs and Formulations (Session 1), 5:00 p.m.-7:00 p.m. Phase II trial of nanoparticle albumin-bound paclitaxel (ABX) + capecitabine (Xel) as first line treatment of metastatic breast cancer (MBC): interim results (Poster Number: 1096)
December 15, 2006, Treatment: Neoadjuvant Therapy (Session 3), 5:00 p.m.-7:00 p.m. Neoadjuvant chemotherapy with sequential weekly nanoparticle albumin-bound paclitaxel (ABI-007, Abraxane(R)) followed by 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in locally advanced breast cancer (LABC): a phase II trial of the NSABP Foundation Research Group (Poster Number: 3068)
December 15, 2006, Treatment: Neoadjuvant Therapy (Session 3), 5:00 p.m.-7:00 p.m. Preliminary results from a multicenter phase II trial of biweekly neoadjuvant gemcitabine, epirubicin, ABI-007 (GEA) with correlative SPARC tumor analysis (Poster Number: 3069)
December 15, 2006, Treatment: Chemotherapy - General (Session 6), 5:00 p.m.-7:00 p.m. Single agent Abraxane given weekly (3/4) as first-line therapy for metastatic breast cancer (an International Oncology Network Study, #I-04-012) (Poster Number: 6073)
About Breast Cancer
According to the American Cancer Society, breast cancer is the most common cancer among women, other than skin cancer, and is the second leading cause of cancer death in women in the United States. The risk of having breast cancer for a woman sometime during her life is about one in eight. In 2006 alone, an estimated 213,000 new cases of breast cancer are expected to occur in women, and an estimated 41,000 women are expected to die from the disease.
The U.S. Food and Drug Administration approved ABRAXANEŽ for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 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. Prior therapy should have included an anthracycline unless clinically contraindicated. For the full prescribing information for ABRAXANEŽ please visit www.abraxane.com.
ABRAXANE was developed by Abraxis BioScience, Inc. ABRAXANE is marketed in the United States under a co-promotion agreement between Abraxis BioScience, Inc. and AstraZeneca Pharmaceuticals LP.
About Abraxis BioScience, Inc.
Abraxis BioScience, Inc. is an integrated global biopharmaceutical company dedicated to meeting the needs of critically ill patients. The company develops, manufactures and markets one of the broadest portfolios of injectable products and leverages revolutionary technology such as its nab(TM) platform to discover and deliver breakthrough therapeutics that transform the treatment of cancer and other life-threatening diseases. The first FDA approved product to use this nab platform, ABRAXANEŽ, was launched in 2005 for the treatment of metastatic breast cancer. Abraxis trades on the NASDAQ Stock Market under the symbol ABBI. For more information about the company and its products, please visit www.abraxisbio.com.
TaxotereŽ is a registered trademark of Sanofi Aventis.
Source: Abraxis BioScience
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