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Biotech / Medical : Biotech News
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From: RMP10/14/2009 9:24:56 AM
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8:35AM Ziopharm Oncology announces positive Palifosfamide Sarcoma randomized Phase II interim data; trial enrollment stopped early (ZIOP) 2.89 : Co announces positive top line interim data from the multicenter randomized Phase II trial of palifosfamide treating patients with unresectable or metastatic soft tissue sarcoma. As a result of reaching a key efficacy milestone and following safety and efficacy data review by the Data Committee, sarcoma experts, and the company's Medical Advisory Board, the decision was reached formally to stop enrollment yesterday in the trial. The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The most frequently reported side effects in both arms of the study include neutropenia and fatigue, hypokalemia, nausea, anemia, leucopenia, and alopecia. Palifosfamide is usually easily administered as an out-patient treatment, and generally well-tolerated. A total of 58 patients have been evaluated for P.F.S. (progression-free survival) with 19 documented PFS events (doxorubicin alone = 13 events; palifosfamide + doxorubicin = 6 events) based on a three month median follow-up time. With this analysis based on all randomized and eligible patients, the hazard ratio is 0.67 favoring palifosfamide + doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.042); the pre-defined milestone was to reach one-sided p=0.1.
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