Ziopharm to begin phase 1/2 trial of organic arsenic as treatment for myeloma

By Angela McDaniels

Seattle, Jan 4 - Ziopharm Oncology Inc. said it has received approval from the Food and Drug Administration to begin a phase 1/2 trial of ZIO-101, a novel organic arsenic, in patients with advanced myeloma.

This announcement follows a similar approval for a phase 1/2 trial for ZIO-201, a novel alkylator, in patients with advanced sarcoma. Patient treatment in both trials is expected to start in early 2006 in the United States, Canada and United Kingdom. Completion of enrollment is expected by the end of 2006, followed by pivotal trials beginning in mid-2007.

Ziopharm said it believes ZIO-101 has the potential to treat patients with myeloma at significantly higher doses compared to arsenic trioxide, an inorganic arsenic currently approved to treat acute promyelogenous leukemia, which has also shown activity in myeloma.

Interim results from phase 1 clinical trials show that dosing of ZIO-101 is 35 times higher than the approved dose of arsenic trioxide, the company said. The interim data also reported evidence of meaningful benefit in one patient and no significant toxicity.

The company said a higher dose coupled with less toxicity will provide a wider therapeutic window and an incremental benefit, or treatment alternative, for myeloma patients, as newly approved agents continue to be associated with significant toxicities or drug resistance at therapeutic doses.

Ziopharm Oncology is a biopharmaceutical company based in New York that re-engineers efficacious but highly toxic therapies to provide more effective and safer cancer therapy for patients.

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