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Abraxane(TM) is active in breast cancer patients who failed taxol or taxotere

Study results further support the thesis that biologically interactive protein nanoparticle enhances the therapeutic potential of taxane therapy.

Abraxis Oncology, a division of American Pharmaceutical Partners, Inc. (APP) (NASDAQ: APPX) today said that results from a 106 patient Phase II study of ABRAXANE in patients with advanced breast cancer whose disease had progressed while they were being treated with TAXOL® and Taxotere® responded to subsequent treatment with ABRAXANETM (albumin nanoparticle paclitaxel). The results were presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, LA, by Joanne Blum, M.D., Ph.D., of the Charles A. Sammons Cancer Center, Baylor University Medical Center in Dallas, TX, one of 38 US Oncology affiliated practices that had patients participate in this clinical study of ABRAXANE.

The Phase II study, sponsored by American BioScience, included 106 patients with progressive metastatic breast cancer whose disease had progressed while being treated with TAXOL or Taxotere in the metastatic setting, or had a relapse within 12 months of adjuvant taxane therapy. The patients enrolled in this study had a very poor prognosis, with 91% having visceral (lung and liver) disease, 65% with more than three metastatic sites, and 88% demonstrating ongoing tumor growth while receiving TAXOL and/or Taxotere in the metastatic setting. Evidence of the activity of weekly doses of ABRAXANE in this highly refractory population is provided by the following findings:

-- A 15% overall response rate (95% CI: 8%-22%) in the 106 patients studied with a 38% probability of survival at 12 months based on analysis of data to date;

-- 40% of patients on treatment with ABRAXANETM were free of disease progression for as long as four months; and almost 30% for as long as six months;

-- Of those patients who progressed while on Taxotere alone in the metastatic setting (n=33), a 24% response rate was noted after receiving weekly ABRAXANETM;

-- Of those patients who progressed while on TAXOL alone in the metastatic setting (n= 31), a 16% response rate was noted after receiving weekly ABRAXANE.

"The demonstration that 15% of patients responded to ABRAXANETM treatment and that 30% had no disease progression after six months in this highly refractory breast cancer population that had progressed even while on TAXOL and/or Taxotere is an important finding. I think this drug has significant potential to benefit women with breast cancer," said Edith Perez, director of the breast cancer program at the Mayo Clinic in Jacksonville, FL.

The tolerability of this weekly regimen was demonstrated by the finding of





Abraxane (TM) este activ în cancerul de sân de pacienþi care nu au rãspuns la taxol sau TAXOTERE - Abraxane(TM) is active in breast cancer patients who failed taxol or taxotere - articole medicale engleza - startsanatate