American BioScience's AC drug combo shows anti-tumor activity in phase 1 study

By Angela McDaniels

Seattle, Dec. 9 - American Pharmaceutical Partners Inc. and American BioScience Inc. said preliminary results of a phase 1 trial of carboplatin in combination with Abraxane administered weekly or every three weeks in patients with solid tumors suggest the drug combination was active in multiple tumor types, including breast cancer, non-small cell lung cancer, melanoma and other solid tumors.

The dose-escalation, 30-patient study was designed to determine the recommended phase 2 dose of Abraxane administered either weekly or every three weeks in combination with carboplatin.

Of the 17 patients in the every-three-weeks regimen, two had a complete response, five had a partial response and five had stable disease, the companies said. Of the 13 patients in the weekly regimen, five had a partial response and five had stable disease.

Additionally, a dose-dense combination therapy of AC (Adriamycin plus Cytoxan) followed by Abraxane (ABI-007) as adjuvant treatment was well tolerated by early stage breast cancer patients in a phase 2 clinical trial.

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 3 clinical trial.

"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," said Patrick Soon-Shiong, chairman and chief executive officer of both companies, in a company news release.

"However, the toxicities associated with solvent-based paclitaxel formulations limited the chemotherapy dose that can be given. In this study with Abraxane, 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."

"These data regarding dose dense Abraxane in the adjuvant setting are timely in light of the results presented at this meeting of the 4,988-patient North American Breast Cancer Intergroup Adjuvant Trial (E1199) solidifying the role of paclitaxel in the adjuvant setting," said lead investigator Nicholas J. Robert of U.S. Oncology Research in the release.

Data from both studies was reported at the 28th Annual San Antonio Breast Cancer Symposium from Dec. 8-11.

The U.S. Food and Drug Administration approved Abraxane for injectable suspension in January 2005, the companies said. It is currently indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.

American BioScience is a privately held biotechnology company based in Santa Monica, Calif., that develops therapeutics for the treatment of life-threatening diseases. It owns a majority interest in American Pharmaceutical Partners, a drug company in Schaumburg, Ill., that develops injectable pharmaceutical products for the oncology, anti-infective and critical care markets.

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