ZIO-101 Oral Capsule Clears FDA Review for Phase I Study

ZIO-101 Oral Capsule Clears FDA Review for Phase I Study 18.1 KB NEW YORK, Jun 01, 2007 (BUSINESS WIRE) -- ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a phase I trial with an oral capsule form of ZIO-101, the Company's proprietary small molecule organic arsenic. The injectable (IV) form of ZIO-101 is currently in three phase II studies including advanced myeloma, liver cancer, and hematological malignancies. The phase I study of oral ZIO-101 will include patients with advanced solid tumors and will evaluate safety and pharmacokinetics. Starting dose will be 300 mg two days per week for three weeks followed by a one week break. "This IND approval is an important achievement as part of the Company's plan to explore the clinical utility of all its drugs in the oral format," commented Jonathan Lewis, MD, PhD Chief Executive Officer of ZIOPHARM. "The prospect of being able to utilize both an oral and an IV version of this novel compound provides the Company with options that greatly enhance the potential for this drug." Separately the Company announced that the United States Adopted Names Council (USAN) and World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee have approved darinaparsin as the non-proprietary name for ZIO-101 (for all forms of the drug). About Darinaparsin Darinaparsin (ZIO-101) is a proprietary small molecule organic arsenic licensed from The University of Texas M. D. Anderson Cancer Center and Texas A&M University. Darinaparsin induces cell cycle arrest and cell death by targeting several cellular pathways essential for cell survival. Exposure to darinaparsin has a direct as well as indirect effect on mitochondrial functions, resulting in depletion of energy supply to the cell and induction of apoptosis (programmed cell death). Increase in intra-cellular Reactive Oxygen Species enhances this effect on mitochondrial functions and consequently the activation of the signal transduction pathway leading to apoptosis. In addition, darinaparsin interrupts the cell cycle at the G2/M phase of tumor cells inducing cell death through this pathway. About ZIOPHARM Oncology, Inc. ZIOPHARM Oncology, Inc. is a biopharmaceutical company engaged in the development and commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer drugs to address unmet medical needs. The Company applies new insights from molecular and cancer biology to understand the efficacy and safety limitations of approved and developmental cancer therapies and identifies proprietary and related molecules for better patient treatment. For more information, visit www.ziopharm.com . Forward-Looking Safe Harbor Statement: This press release contains forward-looking statements for ZIOPHARM Oncology, Inc. that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurance that any of the Company's development efforts relating to its product candidates will be successful, or such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of the Company's product candidates, the risk that the results of clinical trials may not support the Company's claims, and risks related to the Company's ability to protect its intellectual property and its reliance on third parties to develop its product candidates. The Company assumes no obligation to update these forward-looking statements, except as required by law. ZIOP-G SOURCE: ZIOPHARM Oncology, Inc. ZIOPHARM Oncology, Inc. Investors Suzanne McKenna, 646-214-0703 [email protected] or Media Tina Posterli, 917-322-2565 [email protected] Copyright Business Wire 2007 News Provided by COMTEX

The release as fetched from its publisher. alaunos.com ↗