Ziopharm presents data showing ZIO-201 avoids adverse effects of ifosfamide

New York, June 5 - Ziopharm Oncology, Inc. reported that preliminary data from a phase 1 study of ZIO-201 (isophosphoramide mustard-lysine) suggested that the drug does not cause the adverse events associated with ifosfamide, an approved cancer drug extensively used in the United States and Europe.

ZIO-201, the active metabolite of ifosfamide, can be given at much higher doses than ifosfamide and without extensive intravenous hydration or co-administration of the drug mesna, protective measures required with ifosfamide use.

The findings are from a phase 1 study involving outpatients with progressive cancers following extensive therapy with other drugs.

The maximum tolerated dose of ZIO-201 was about 1.5 g/me2/cycle, a dose the company estimates to be equivalent to 15-30 g/me2/cycle of ifosfamide. Ifosfamide is rarely given at this level because of substantial bladder and central nervous system toxicity, problems not evident in the trial of ZIO-201.

One patient with mesothelioma receiving ZIO-201 had stable disease for more than one year.

Confirmation of the maximum tolerated dose and exploration of alternative dosing schedules is ongoing.

Ziopharm, a New York biopharmaceutical company, reported the data at the annual meeting of the American Society of Clinical Oncology in Atlanta.

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