NEW YORK, March 6, 2013 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today announced the start of a multicenter, single arm Phase 2 investigator-sponsored study of palifosfamide (ZIO-201) in patients with recurrent metastatic germ cell (testicular and ovarian) tumors who have relapsed on initial platinum-based therapy and high dose chemotherapy, or patients who are not eligible for high dose chemotherapy. The study is being conducted at the Melvin and Bren Simon Cancer Center at the Indiana University, led by Lawrence Einhorn, M.D., Distinguished Professor of the Department of Medicine, Division of Hematology/Oncology at the School of Medicine. ZIOPHARM is currently conducting Phase 3 trials of palifosfamide in first-line metastatic soft tissue sarcoma (PICASSO 3) and first-line metastatic small cell lung cancer (MATISSE). Dr. Einhorn is the lead principal investigator for the MATISSE trial. The Company expects to announce topline results from PICASSO 3 the last week of this month. "While treatments for germ cell cancers are often effective, and five-year survival is high, there remains a population for whom relapse or a lack of tolerability lead to poor prognosis," said Dr. Einhorn. "Palifosfamide is in the same molecular class as ifosfamide, an agent that has transformed the treatment of testicular cancer. Our early experience in Phase 1 testing with palifosfamide in patients with resistant testicular and ovarian germ cell tumors is quite encouraging. Data from the Phase 2 study will inform us of how best to advance the use of palifosfamide in these diseases." The primary endpoint is response rate (CR+PR) of single agent palifosfamide in patients with refractory germ cell tumors. The secondary endpoints include the duration of remission, progression-free survival (PFS), overall survival (OS) and the safety profile of palifosfamide in patients with germ cell tumors. In this trial, twelve patients will be treated with palifosfamide (150 mg/m 2 3 days every 3 weeks for 6 cycles) and, if at least 1 response (RR of ≥ 8.5%) is observed, enrollment will continue to a total of twenty patients to evaluate response rate of single agent palifosfamide. Additionally, the response rate will be assessed every cycle by RECIST v1.1 and by serum AFP and beta-hCG. 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.Ad-RTS IL-12 is currently being tested in a Phase 2 study. Ad-RTS IL-12 uses synthetic biology to enable controlled, local delivery of therapeutic interleukin-12 (IL-12), a protein important for an immune response to cancer. ZIOPHARM's DNA synthetic biology platform is being developed in partnership with Intrexon Corporation and employs an inducible gene-delivery system that enables controlled, local delivery of genes that produce therapeutic proteins to treat cancer. This is achieved by placing IL-12 under the control of a proprietary biological "switch" (the RheoSwitch Therapeutic System ®, RTS ®) to turn on/off the therapeutic protein expression at the tumor site. Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and a tolerable toxicity profile. It is currently being studied in a Phase 1/2 trial in metastatic breast cancer. Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent (organic arsenic) currently in ongoing studies with Solasia Pharma K.K. ZIOPHARM's operations are located in Boston, MA, and New York City. Further information about ZIOPHARM may be found at www.ziopharm.com . Forward-Looking Safe Harbor Statement: This press release contains certain forward-looking information about ZIOPHARM Oncology that is intended to be covered by the safe harbor for "forward-looking statements" provided by the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. Words such as "expect(s)," "feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding our ability to successfully develop and commercialize our therapeutic products; our ability to expand our long-term business opportunities; financial projections and estimates and their underlying assumptions; and future performance. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include, but are not limited to: whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, or any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether Palifosfamide, Ad-RTS IL-12, Darinaparsin, Indibulin, and our other therapeutic products will be successfully marketed if approved; whether any of our other DNA-based biotherapeutics discovery and development efforts will be successful; our ability to achieve the results contemplated by our collaboration agreements; the strength and enforceability of our intellectual property rights; competition from pharmaceutical and biotechnology companies; the development of and our ability to take advantage of the market for DNA-based biotherapeutics; our ability to raise additional capital to fund our operations on terms acceptable to us; general economic conditions; and the other risk factors contained in our periodic and interim SEC reports filed from time to time with the Securities and Exchange Commission, including but not limited to our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2012. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.
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