ZIOPHARM STARTS TRIAL OF DRUG FOR HEMATOLOGICAL CANCERS

Ziopharm Oncology announced that 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 U.S. 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.

"Preclinical and Phase I trial results were very encouraging and demonstrated that ZIO-101 has anti-leukemia activity and may be an effective treatment in diverse blood and bone marrow cancers," Robert Gale, senior vice president for research, said.

The company plans to initiate Phase II trials with ZIO-101 in solid cancers this quarter and expects to file an investigational new drug application for a Phase I study with an oral formulation of ZIO-101.

ZIO-101 induces cell cycle arrest and cell death by targeting several cellular pathways essential for survival. Exposure to ZIO-101 has a direct as well as indirect effect on mitochondrial functions, resulting in depletion of energy supply to the cell and induction of apoptosis (programmed cell death). Increase in intra-cellular reactive oxygen species enhances this effect on mitochondrial functions and consequently the activation of the signal transduction pathway leading to apoptosis. In addition, ZIO-101 interrupts the cell cycle at the G2/M phase of tumor cells, inducing cell death through this pathway as well.