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Cell Therapeutics Announces Agreement for Phase II Study of Pixantrone in Metastatic Breast Cancer

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Cell Therapeutics, Inc. (CTI) has announced an agreement with the North Central Cancer Treatment Group (NCCTG) to conduct a phase II study of pixantrone in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens.

The trial will be conducted through the NCCTG, a national network of cancer specialists at community clinics, hospitals, and medical centers in the United States and Canada. The research base for NCCTG is located at Mayo Clinic in Rochester, MN.

"We are very pleased that the NCCTG has selected pixantrone for this study. Patients with HER2-negative breast cancer who have relapsed after primary chemotherapy have a need for effective and well-tolerated new agents. Although highly active, usage of drugs in the anthracycline class as salvage agents has declined, predominantly due to concerns regarding cardiac toxicity," said Jack Singer, M.D., Chief Medical Officer of the Company. "Based on its safety and activity in non-Hodgkin's lymphoma, pixantrone has the potential to be an active agent in breast cancer that could be safely used in this setting. We look forward to the NCCTG initiating this trial."

The proposed trial design is to test two different dosing schedules of pixantrone. Patients on the trial will be randomized to receive either 180 mg/m2 every three weeks, or 85 mg/m2 weekly for three weeks with a one-week break. The goal of the trial would be to test the safety and efficacy of each regimen and potentially select the one with the best benefit/risk profile for further development in a phase III trial against a standard second- or third-line treatment.