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Two New Clinical Studies of Abraxane Initiated in Patients With Non-Small Cell Lung Cancer, Metastatic Melanoma

SANTA MONICA, Calif., Feb. 25 /PRNewswire/ -- American BioScience, Inc. (ABI) today announced it has initiated clinical studies of weekly administration of ABRAXANE™, a next generation, solvent-free, nanoparticle albumin-bound taxane, in two new oncology indications: non-small cell lung cancer and metastatic melanoma.

A single-center, dose-escalation Phase I/II clinical trial has begun in the U.S. with ABRAXANE™ in patients with chemotherapy naive, advanced non-small cell lung cancer (NSCLC). The dose-escalation study is designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of ABRAXANE, administered intravenously weekly, and evaluate the safety and antitumor activity of ABRAXANE in patients with advanced stage NSCLC. The study is expected to be expanded into a Phase II efficacy study at the MTD to evaluate that safety and antitumor activity of ABRAXANE.

"We are excited about the possibilities of ABRAXANE as a treatment for advanced non-small cell lung cancer," said Michael J. Hawkins, M.D., chief medical officer of ABI. "Data from a recently completed Phase III clinical trial comparing ABRAXANE with TAXOL® in patients with metastatic breast cancer showed statistically superior response rates and time to tumor progression with ABRAXANE. Since TAXOL is known to be an active drug in non-small cell lung cancer, we are hopeful that ABRAXANE will also prove more beneficial in this disease as well."

Separately, a multicenter Phase II trial has been initiated in patients with metastatic melanoma to evaluate the safety and tolerability and antitumor effect of ABRAXANE. The trial will evaluate both chemotherapy naive patients (at a dose of 150mg/m2 administered weekly) and patients who have previously received chemotherapy (at a dose of 100mg/m2 administered weekly) as treatment for metastatic disease.

"During the course of our involvement in a Phase I study with weekly administration of ABRAXANE we included patients with pretreated metastatic melanoma and we noticed several partial remissions," said Evan M. Hersh, M.D., Professor of Medicine, Microbiology, and Immunology at the Arizona Cancer Center, Tucson, AZ. "Given these preliminary anecdotal observations, the current body of data for ABRAXANE, as well as the fact that paclitaxel has been shown to have some antitumor activity in melanoma patients, we are hopeful that this drug will have significant activity in melanoma."

Lung cancer is the single largest cause of cancer deaths in the United States and NSCLC is the most common form of the disease, accounting for almost 80% of all cases. Approximately 169,000 Americans were diagnosed with lung cancer in 2002 and an estimated 154,000 people died from the disease.

Cancer of the skin is the most common of all cancers and while melanoma accounts for about 4% of skin cancer cases, it causes about 79% of skin cancer deaths. The number of new cases of melanoma in the United States is on the rise. The American Cancer Society estimates that in 2004 there will be 55,100 new cases of melanoma in this country and about 7,910 people will die of this disease.

ABI has licensed the North American manufacturing and marketing rights for ABRAXANE™ to American Pharmaceutical Partners, Inc. (APP) including this indication for lung cancer, and has initiated a New Drug Application (NDA) filing with the FDA of ABRAXANE for the treatment of metastatic breast cancer.

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