In October 2012, ZIOPHARM initiated a Phase 2 multi-center, single-arm, open-label expansion study that will enroll up to 15 patients with unresectable Stage III or IV melanoma. This study will further evaluate the safety and efficacy of intratumoral injections of Ad-RTS IL-12. Data from this study are expected in the second half of 2013. The study follows completion of a successful, dose-escalation Phase 1 study in which clinical activity was observed in 5 of 7 (71%) patients dosed at the two highest dose levels.
In November 2012, the Company announced results from a preclinical study demonstrating the long-term persistence and anti-tumor effects of a new synthetic biology approach (DNA/cell plasmid) to controlled protein production in vivo. This embedded controlled bioreactor study was presented at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics. The Company also presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting in March/April 2012, demonstrating the significant anti-tumor activity of Interleukin-12 (IL-12) and interferon alpha (IFNα), two proteins involved in immune response to cancers, expressed in vivo utilizing a regulated gene system. The presentation was recognized as among the best science by the AACR Program Committee, a designation awarded to the top 2.5 percent of abstracts.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development and commercialization of new cancer therapies. The Company's clinical programs include:Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that has activity in multiple tumors by evading typical resistance pathways. Palifosfamide is in the same class as bendamustine, cyclophosphamide, and ifosfamide. Intravenous palifosfamide is currently being studied in a randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for the treatment of first-line metastatic soft tissue sarcoma and is also in a pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung cancer. Additionally, the Company is developing an oral capsule form of palifosfamide.