Ziopharm progressing with phase I cancer trials

ZIO-101 is the first compound from a family of novel organic arsenics. Preclinical evidence suggests that because of the potential for much higher doses and pharmacokinetic differences between organic and inorganic arsenics, ZIO-101 may be active in a broad range of cancers.

Safety and dosing of ZIO-101 will be tested in up to 40 patients with blood and bone marrow cancers in the phase I trial, and will also be tested in a second phase I study in solid cancers that Ziopharm expects to begin in the coming months.

The company’s second clinical-stage compound, ZIO-201 (L-IPM , or lysine-isophosphoramide mustard), is in an ongoing phase I safety and dose ranging study at the Karmanos Cancer Center in Detroit, with a second site scheduled to be added to that trial in the near future.

Pharmaceutical formulation instability previously precluded clinical development of isophosphoramide mustard but L-IPM is a stabilized pharmaceutical preparation. Data so far include L-IPM activity in cyclophosphamide and ifosfamide resistant cancers. L-IPM, unlike ifosfamide, is not metabolized to acrolein or acetaldehydes: preclinical studies show no central nervous system, kidney or bladder toxicities.

“With two products in the clinic so soon after initiating operations, Ziopharm is delivering on its strategy to deliver novel therapies in a timely fashion to clinicians and their patients with cancer,” commented Dr Jonathan Lewis, CEO of Ziopharm. “We expect this milestone to be the first of many in the clinic this year.”