ZIO-101 (Darinaparsin) Early Interim Multiple Myeloma Phase I/II Data Presented at ASCO
2007-06-02 · Alaunos Therapeutics · original alaunos.com ↗
ZIO-101 (Darinaparsin) Early Interim Multiple Myeloma Phase I/II Data Presented at ASCO 19.5 KB NEW YORK, Jun 02, 2007 (BUSINESS WIRE) -- ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today the presentation of ZIO-101 (darinaparsin) Phase I/II advanced multiple myeloma data at the 2007 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The poster entitled, "ZIO-101 (S-dimethylarsino-glutathione): Phase 1/2 trials in advanced / progressive multiple myeloma" was presented by J.R. Berenson, M.D., Berenson Oncology, Inc., West Hollywood, CA, and principal investigator. Darinaparsin is a novel organic arsenic with a multifaceted mechanism of action different from other forms of arsenic commercially available. The two ongoing Phase II studies are evaluating the preliminary efficacy and safety profile of different treatment schedules (5 consecutive days every four weeks; twice weekly for 3 weeks, every four weeks) in patients with advanced/progressive myeloma (patients to date have had a median of 7 prior therapies). As reported, of the 14 patients treated 5 consecutive days, there are 10 patients evaluable for efficacy, with 4 out of the 10 (40%) achieving stable disease greater than 4 months duration. Data from the twice weekly study is not yet evaluable (3 patients treated). Darinaparsin has been well tolerated and no clinically relevant QT prolongation, bone marrow suppression or neuropathy has been observed with either treatment schedule. "The treatment of advanced multiple myeloma is evolving very rapidly with the availability of the newer agents," commented Dr. Berenson. "It is very likely that future advances in the treatment of earlier-stage disease will be most dramatic using combinations of novel agents. Darinaparsin, with its novel mechanism, unique activity and relatively benign side-effect profile may be ideally suited to this combination approach. There is similarly a need for such an agent to treat these highly pretreated and relapsed patients." ZIOPHARM is continuing to enroll patients in both phase II trials. Preclinical studies in myeloma cell lines have indicated synergy of darinaparsin with Velcade(R), the basis for further exploring clinical study in combination study that is in the advanced stages of planning. The Company is in the late planning stages of a trial in Eastern Europe that would treat a less advanced patient population. ZIOPHARM is also enrolling patients in Phase II trials of darinaparsin for the treatment of primary liver cancer and diverse hematological cancers. Phase I trials with an oral form of darinaparsin are expected to be underway soon. For more details on these trials please see www.clinicaltrials.gov . About Darinaparsin (ZIO-101) Darinaparsin 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 For ZIOPHARM Oncology, Inc. Media Tina Posterli, 917-322-2565 [email protected] Copyright Business Wire 2007 News Provided by COMTEX
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