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news.The FDA has approved Ziopharm's investigational new drug application for the clinical development of its proprietary organic arsenic compound, ZIO-101, which is to be evaluated in patients with hematological cancers.
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“We are very pleased to advance ZIO-101 as our second compound in clinical development and to have met our timeline,” commented Dr Mark Thornton, head of product development and chief medical officer at Ziopharm.
“This represents an important milestone for Ziopharm, and on the basis of encouraging preclinical safety data, we intend to begin treating patients with ZIO-101 at doses approximately 14 times higher than the FDA approved starting dose of inorganic arsenic trioxide.”
ZIO-101, the company’s first in-licensed product, is a small molecule from The University of Texas MD Anderson Cancer Center and Texas A&M University. A second organic arsenic from that broad licensing arrangement, ZIO-102, is expected to undergo further preclinical study this year as ZIO-101 progresses through phase I studies in both hematologic and solid tumor cancers.