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Positive Results Observed With Dose-Dense Combination Therapy of Adriamycin, Cytoxan, and Abraxane

SCHAUMBURG, Ill. and SANTA MONICA, Calif., Dec. 9 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (APP) (NASDAQ:APPX) and American BioScience, Inc. (ABI) today said positive results were observed with dose-dense combination therapy in early-stage breast cancer patients who received AC (Adriamycin(R) plus Cytoxan(R)) followed by ABRAXANE(R) as adjuvant treatment. Additionally, activity was observed in a combination study of ABRAXANE and carboplatin in multiple solid tumor types, including lung and breast cancer. The data from these studies were reported at the 28th Annual San Antonio Breast Cancer Symposium at the Henry B. Gonzalez Convention Center, San Antonio, December 8-11, 2005.

"Many support the notion that a dose-dense regimen, which seeks to deliver the greatest amount of chemotherapy possible in the shortest period of time, is the most effective regimen as adjuvant therapy for breast cancer. However, the toxicities associated with solvent-based paclitaxel formulations limited the chemotherapy dose that can be given," said Patrick Soon-Shiong, M.D., chairman and chief executive officer of APP and chairman and chief executive officer of ABI. "In this study with ABRAXANE(R), a solvent-free albumin-bound paclitaxel, it was possible to provide a patient with more of the active drug than is typically given with Taxol. We believe the data reported are exciting and provide an increasingly sound rationale for further evaluation of ABRAXANE(R) in combination regimens for breast cancer in the adjuvant setting."

"These data regarding dose dense ABRAXANE(R) in the adjuvant setting are timely in light of the results presented at this meeting of the 4988 patient North American Breast Cancer Intergroup Adjuvant Trial (E1199) solidifying the role of paclitaxel in the adjuvant setting," stated Nicholas J. Robert, M.D., principal investigator of the pilot study, and Co-Chair, Breast Cancer Committee, US Oncology Research.

Pilot Study of Dose-Dense Doxorubicin plus Cyclophosphamide Followed by ABI-007 (ABRAXANE) in Patients with Early-Stage Breast Cancer
Preliminary results from a phase II trial showed that dose-dense therapy with doxorubicin (Adriamycin(R)) (A) plus cyclophosphamide (Cytoxan(R)) (C) followed by dose-dense ABRAXANE was well tolerated in patients with early stage breast cancer. The open label pilot study was designed to evaluate the toxicity of AC therapy followed by ABRAXANE 260 mg/m2 every two weeks for four cycles each as adjuvant therapy in patients with early stage breast cancer. This study was conducted in preparation for a large randomized Phase III clinical trial.

Preliminary Results of a Phase I Trial of Carboplatin in Combination with ABI-007 (ABRAXANE) Administered Weekly or Every 3-Weeks in Patients with Solid Tumors
Preliminary data suggest the combination of ABRAXANE and carboplatin was active in multiple tumor types, including breast cancer, non-small cell lung cancer (NCSLC), melanoma and other solid tumors. The Phase I dose escalation study was designed to determine the recommended Phase II dose of ABRAXANE administered either weekly or every three weeks in combination with carboplatin. 30 patients (n=17 ABRAXANE administered every three weeks, n=13 ABRAXANE administered weekly) were enrolled in the study (NSCLC - 8, melanoma - 8, SCLC - 3, CUP - 2, breast - 2, pancreatic - 1, bladder - 1, esophageal - 1, gastric - 1, sarcoma - 1, prostate - 1, colon - 1). Of the 17 patients in the every three weeks regimen, two had a complete response (CR) (one with NSCLC at 220 mg/m2 and one with CUP at 300 mg/m2), five had a partial response (PR) (one with SCLC and one with NSCLC at 260 mg/m2, one with CUP at 300 mg/m2, one with SCLC and one with esophageal at 340 mg/m2) and five had stable disease. Of the 13 patients in the weekly regimen, five had a PR (two with melanoma and one with bladder cancer at 100 mg/m2, and one with pancreatic and one with melanoma at 125mg/m2) and five had stable disease.

Source: American Pharmaceutical Partners, Inc.

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