Ziopharm Oncology, Inc. has submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) to begin clinical study of Ad-RTS-IL-12 (INXN 2001/1001), a novel DNA-based therapeutic candidate.
The Phase 1 study will evaluate safety, and immunological and biological effects of the therapeutic candidate in patients with melanoma. Ad-RTS-IL12 is the second clinical oncology product candidate from the Ziopharm/Intrexon Corporation’s synthetic biology channel partnership.
Through intratumoral injection, Ad-RTS-IL-12 employs an adenoviral vector (Ad) to deliver directly into the patient’s own cells a gene that expresses Interleukin-12 (IL-12), a potent anticancer cytokine. Production of IL-12 within the cell is in turn tightly regulated by the Intrexon RheoSwitch Therapeutic System (RTS), a “gene switch” controlled by an activator ligand taken orally. IL-12 is a naturally occurring regulatory cytokine that has a function central to the initiation and regulation of cellular immune responses.
Data from two preclinical studies of Ad-RTS-IL-12 in various in vivo cancer models will be presented at the 2011 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT). Data from a Phase 1b trial with DC-RTS-IL-12 will be presented at the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Release Date: May 13, 2011
Source: ZIOPHARM Oncology, Inc
Filed Under: Drug Discovery