FDA Accepts Ziopharmâ€™s IND Application for ZIN ATI-001
When initiated, the Phase I study will evaluate safety in addition to immunological and biological effects of the therapeutic candidate in patients with melanoma.
Preclinical studies have shown that the immunological mechanism of action of ZIN ATI-001 is similar to that of ZIN-CTI-001 (DC-RTS-IL-12 + AL), Ziopharmâ€™s most advanced DNA-based product candidate, currently in Phase Ib.
ZIN ATI-001 is the second clinical oncology product candidate from the Ziopharm-Intrexon Corporation exclusive synthetic biology channel partnership.
Production of IL-12 within cells is then tightly regulated by the Intrexon RheoSwitch Therapeutic System (RTSTM), a gene switch controlled by an orally administered activator ligand (AL).
RJ Kirk, chairman and CEO of Intrexon, and a director of board of directors of Ziopharm, said: â€œThe rapid acceptance of this IND underscores Ziopharmâ€™s strengths as our exclusive partner for the development of DNA-based therapeutics in oncology.
â€œZIN ATI-001, which offers an effective, yet simpler approach to introducing IL-12 therapy, is the first of many products we expect to introduce into the clinic as partners over the next two years. Ziopharmâ€™s understanding of the development spectrum, from preclinical work through large outcome studies, ensures that the great promise of this technology is delivered quickly and intelligently.â€
Will the firm get positive results from the study?
Have your say and discuss with your peers on the InfoGrok community.
Participate by posting your comments now.