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FDA OKs ZIOPHARM Oncology Inc.’s (ZIOP) New Drug Application for DNA-based Therapeutic Candidate

ZIOPHARM Oncology Inc., a biopharm company engaged in the development and commercialization of a diverse portfolio of cancer therapeutics, Friday announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s investigational new drug (IND) application, giving the company the go-ahead to commence clinical study of ZIN ATI-001, a novel DNA-based therapeutic candidate.

RJ Kirk, Intrexon’s chairman and CEO, and a director of the ZIOPHARM board of directors, said the quick approval of the IND reflects the company’s strength in DNA-based therapeutics in oncology.

ZIOPHARM is focusing on pursuing the development of novel DNA-based therapeutics for oncology pursuant to an exclusive channel partnership with Intrexon Corporation. The partnership includes two existing clinical-stage product candidates, the first of which is in a phase Ib study (ZIN ATI-00) and the second, entering phase I study.

The phase I study will evaluate safety as well as immunological and biological effects of ZIN ATI-001in patients with melanoma. In preclinical studies, the immunological mechanism of action of ZIN ATI-001 is similar to ZIOPHARM’s most advanced DNA-based product candidate, ZIN ATI-00.

ZIN ATI-001 is the second clinical oncology product candidate from ZIOPHARM-Intrexon’s exclusive synthetic biology channel partnership, and according to Kirk, is the first of many products the company anticipates introducing into the clinic.

Positive clinical data of ZIN-CTI-001 is the first-ever to demonstrate small molecule-controlled production of an anticancer protein in humans; the company recently presented this data at the 2011 Annual Meeting of the American Society of Clinical Oncology.

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