Data evaluating use of nab-paclitaxel for treatment of pancreatic cancer to be presented at ASCO 2010

May 21 2010

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, previously announced it will be presenting more than 30 studies, including new clinical data evaluating the use of nanoparticle albumin bound (nab^®) driven chemotherapy, nab-paclitaxel (ABRAXANE^® for Injectable suspension; paclitaxel protein albumin-bound particles for injectable suspension) for the treatment of pancreatic cancer at the 46^th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. A phase 2 clinical study evaluating nab-paclitaxel (100 mg/m²) in advanced pancreatic cancer patients who have progressed on gemcitabine-based therapy (Abstract #4120), treatment resulted in 58 percent of patients achieving six-month overall survival (OS), with a median survival of 7.3 months and a median progression-free survival (PFS) of 1.6 months. Five patients remain alive at a median follow-up of 12.7 months, including one patient with stable disease (SD) on cycle 15 of therapy. Complete trial results will be presented during a poster session on June 6 at 2 p.m. CT.

“The success of ABRAXANE in patients with pancreatic cancer supports our belief and understanding of how the nab-driven chemotherapy leverages the tumor biology against itself to increase efficacy”

"The results of this study demonstrate that single agent nab-paclitaxel is active in pancreas cancer patients who have previously progressed on gemcitabine-based therapy," said Caio Max Rocha Lima, M.D., Associate Professor of Clinical Medicine, University of Miami Sylvester Comprehensive Cancer Center.

The pancreatic trial results follow recent findings from a phase 1/2 study of nab-paclitaxel in combination with gemcitabine, which demonstrated increased survival in first-line treatment of patients with advanced pancreatic cancer. Presented at the 101^st Annual Meeting of the American Association for Cancer Research (AACR) in April 2010, median OS for 44 patients treated at the recommended dose of 125 mg/m² nab-paclitaxel plus gemcitabine (1000 mg/m²) was 12.2 months, a doubling of survival compared to historical control of gemcitabine alone. ABRAXANE has been granted orphan drug designation by the Food and Drug Administration for the treatment of pancreatic cancer as well as stage IIB-IV melanoma. Enrollment is ongoing for a phase 3 trial program evaluating nab-paclitaxel plus gemcitabine versus gemcitabine alone as a first-line therapy for advanced metastatic pancreatic cancer.

"The success of ABRAXANE in patients with pancreatic cancer supports our belief and understanding of how the nab-driven chemotherapy leverages the tumor biology against itself to increase efficacy," said Patrick Soon-Shiong, M.D., Executive Chairman and founder of Abraxis BioScience. "We believe ABRAXANE exploits the albumin-binding protein receptor, Gp60, to penetrate the blood-stroma barrier in essence opening a portal to the tumor micro-environment, enabling the delivery of targeted cytotoxic agents leading to stromal collapse and tumor penetration."

Pancreatic cancer can be particularly hard to treat because many patients are diagnosed after their disease has progressed. This year more than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States and more than 35,000 people will die from the disease. Recent research indicates that an exceptionally dense stroma around pancreatic tumors contributes to treatment difficulty, and that delivery systems that can break through this surrounding mass may deliver more drug to the cells and improve outcomes.