PHASE III ABRAXANE STUDY DATA PUBLISHED

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American Pharmaceutical Partners and American BioScience have announced that the Journal of Clinical Oncology published data from a pivotal Phase III clinical trial pertaining to efficacy, safety and survival associated with Abraxane for injectable suspension (paclitaxel protein-bound particles for injectable suspension, albumin-bound) in metastatic breast cancer.

The objective of the Phase III trial was to confirm previous studies suggesting superior efficacy and reduced toxicity of Abraxane compared with standard paclitaxel (Taxol) and to confirm the activity of Abraxane noted in a Phase II study in metastatic breast cancer patients. The trial showed that there was a trend for greater median survival for all patients treated with Abraxane than with Taxol. Although no statistical difference in survival was observed in first-line patients, a statistically significant prolongation in median survival by over two months was observed in patients who received Abraxane as second-line or greater therapy, compared with Taxol.