New York, USA-based ZIOPHARM Oncology says that its ZIO-101, a novel, proprietary organic arsenic, has been administered to the first patient in a Phase II trial in blood and bone marrow cancers. Designed to confirm the anticancer activity of ZIO-101 seen in the Phase I hematological trial, patients will receive intravenous ZIO-101 once-daily for five consecutive days every four weeks for up to six cycles. The company anticipates enrolling up to 40 patients at five US clinical sites.
This study complements an ongoing Phase II trial to treat advanced multiple myeloma in which the drug is administered using this same schedule as well as a second trial with a schedule that is twice-weekly for three consecutive weeks.
The company plans to initiate Phase II trials with ZIO-101 in solid cancers in the first quarter of 2007 and expects to file an Investigational New Drug application for a Phase I study with an oral formulation of the agent.
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