ZIOPHARM Treats Patients in U.S. Phase I Trials of Oral Darinaparsin and Indibulin.Company Receives First Notice of Allowance for Oral Darinaparsin Patent NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- ZIOPHARM Oncology, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ZIOP) announced today that the company has begun dosing patients in a U.S. phase I trial of its oral formulation of darinaparsin (ZIO-101) to treat solid tumors. The Company has also initiated patient treatment in a U.S. phase I trial of the oral formulation of indibulin (ZIO-301) in solid tumors. The Company's strategy is to pursue oral formulations for all of their compounds as oral formulations may offer considerable advantages over infusion formulations including patient convenience, cost savings, and commercial benefit. Separately, the Company announced that Australia has determined that certain patent claims for darinaparsin (ZIO-101), the Company's proprietary organic arsenic, are in condition for allowance. These claims will cover treatment of cancer using organic arsenic, including darinaparsin, as single agents and in combination with other agents or therapies. Most importantly Adv. 1. most importantly - above and beyond all other consideration; "above all, you must be independent" above all, most especially the claims will cover all oral formulations of organic arsenic. The Company also announced the expansion of the intellectual property portfolio covering indibulin (ZIO-301) and its use in the treatment of cancer by the allowance of claims in India, Turkey and Iceland and the recent issuance of patents in Israel and Slovakia. Jonathan Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, commented, "We were especially pleased to initiate patient dosing in our two U.S. phase I trials of the oral formulations of darinaparsin and indibulin as we believe each compound may hold significant clinical and commercial potential as both single agents and in combination with other oncology therapies." "The new patents and allowances for both darinaparsin and indibulin add significantly to our growing intellectual property portfolio," concluded Dr. Lewis. About Darinaparsin (ZIO-101) Darinaparsin is a proprietary, small-molecule organic arsenic licensed exclusively to ZIOPHARM 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 mitochondrial pertaining to mitochondria. mitochondrial RNAs a unique set of tRNAs, mRNAs, rRNAs, transcribed from mitochondrial DNA by a mitochondrial-specific RNA polymerase, that account for about 4% of the total cell RNA that functions, resulting in depletion of energy supply to the cell and induction of apoptosis (programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the ). Increase in intra-cellular Reactive Oxygen Species reactive oxygen species, n molecules and ions of oxygen that have an unpaired electron, thus rendering them extremely reactive. Many cellular structures are susceptible to attack by ROS contributing to cancer, heart disease, and cerebrovascular disease. enhances this effect on mitochondrial functions and consequently the activation of the signal transduction pathways leading to apoptosis. In addition, darinaparsin arrests the cell cycle at the G2/M phase of tumor cells, causing cell death by this pathway also. ZIOPHARM is enrolling patients in two ongoing phase II studies evaluating the preliminary efficacy and safety profile of different treatment schedules of darinaparsin (ZIO-101) in patients with advanced/progressive myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow. giant cell myeloma see under tumor (1). (patients to date have had a median of seven prior therapies). ZIOPHARM is also enrolling patients in phase II trials of darinaparsin for the treatment of primary liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. and diverse hematological hematological, hematologic pertaining to or emanating from blood cells. hematological tests total and differential white cell counts, hematocrit estimation, erythrocyte count. cancers. Phase I trial with an oral form of darinaparsin has been initiated. For more details on these trials please see www.clinicaltrials.gov. About Indibulin (ZIO-301) Indibulin (ZIO-301) is a novel synthetic anti-mitotic agent that binds to tubulin tubulin /tu·bu·lin/ (too´bu-lin) the constituent protein of microtubules. tu·bu·lin n. A globular protein that is the structural constituent of microtubules. , destabilizes microtubule microtubule Tubular structure enclosed by a membrane found within animal and plant cells. Of varying length, they have several functions. They help give shape to many cells and are major components of cilia and flagella, participate in the formation of the spindle during polymerization polymerization Any process in which monomers combine chemically to produce a polymer. The monomer molecules—which in the polymer usually number from at least 100 to many thousands—may or may not all be the same. , and arrests tumor cell growth at the G2/M phase. Microtubules Microtubules Slender, elongated anatomical channels in worms. Mentioned in: Antihelminthic Drugs are well-established targets for anti-cancer drug development and tubulin-binding drugs such as taxanes and vinca alkaloids vinca alkaloids a group of alkaloids, including vinblastine and vincristine, extracted from the periwinkle plant (Vinca rosea), which arrest cell division in metaphase by disrupting the microtubules that form the spindle apparatus; used as antineoplastic agents. are currently widely used to treat cancer. Indibulin is in a Phase I dose-ranging and safety study in Europe and the United States. The Company expects to begin Phase II trials in the U.S. soon. About ZIOPHARM Oncology 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 Statements This news release contains forward-looking statements based on current expectations, forecasts and assumptions that are subject to risks and uncertainties that 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 that such product candidates will be successfully commercialized. Other risks that affect forward-looking information contained in this news 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. For further risk factors see the Company's 10-KSB filed with the SEC. ZIOP-G |
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