New data demonstrate anti-tumor activity for ABRAXANE

May 29, 2009

By hammersmith

[Source: Business Wire] – Abraxis BioScience, Inc., a fully integrated biotechnology company, today announced results from an ongoing phase I/II clinical study evaluating ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (100, 125 or 150 mg/m2) administered in combination with the standard chemotherapy gemcitabine (1,000 mg/m2), for the treatment of patients with advanced metastatic pancreatic cancer. In a preliminary analysis of 67 patients, investigator-assessed results showed the median survival rate for patients treated with the ABRAXANE/gemcitabine combination was 10.3 months across all dose levels. The combination also resulted in a disease control rate (confirmed complete response (CR), partial response (PR) and stable disease for 16 weeks or longer according to RECIST criteria) of 70 percent. Five percent of patients achieved a CR, 39 percent of patients achieved a PR and 26 percent of patients had stable disease for 16 weeks or longer. Study results also showed a higher response rate among patients who expressed the biomarker, secreted protein acidic and rich in cysteine (SPARC), compared to SPARC negative patients. More specifically, eighty percent of SPARC-positive patients (8 of 10) achieved a response compared to 36 percent (8 of 22) of SPARC-negative patients, (p=0.027). These findings were presented in a poster discussion session of Abstract #4525 on May 31st at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla.

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