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Ziopharm Oncology Inc. (ZIOP) Submits IND to FDA for Melanoma Therapeutic Candidate

Ziopharm Oncology Inc., a biopharmaceutical company focused on the development and commercialization of cancer therapeutics, has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to commence a clinical study of the company’s therapeutic candidate for patients with melanoma.

Ad-RTS-IL-12 (INXN 2001/1001) is a novel DNA-based therapeutic candidate. If the IND is approved, the phase I clinical study will be conducted to evaluate the safety of, and the immunological and biological effects of, the drug.

Ad-RTS-IL12 is the second clinical oncology product candidate from the Ziopharm/Intrexon Corp. exclusive, synthetic biology channel partnership.

“Cancer is a disease of DNA and synthetic biology uses genetic tools to offer us entirely new approaches to addressing its challenges,” Mark Thornton, M.D., Ph.D., executive vice president and chief development officer of Ziopharm stated in the press release.

Dr. Thornton detailed how the drug works:”IL-12, for example, naturally elicits an immune response to cancer, but is too toxic to be given as a recombinant protein. By producing IL-12 in the body with a DNA-based drug, and using our unique technology to switch this production on or off with a pill, we expect to achieve therapeutic levels of IL-12 without being limited by the toxicities typically associated with recombinant therapy. Both Ad-RTS-IL-12 and DC-RTS-IL-12 (INXN 3001/1001), our clinical-stage candidate that employs the patient’s transduced dendritic cells to deliver Ad-RTS-IL-12, represent truly novel and pioneering treatment.”

The company will present data from two preclinical studies of Ad-RTS-IL-12 in various in vivo cancer models at the 2011 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), May 18-21 in Seattle, Wash.

Data from a phase Ib trial with DC-RTS-IL-12 will be presented at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO) June 3-7 in Chicago, Ill.

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