ZIOPHARM Commences Oral Indibulin Phase I/II Trial in Breast Cancer -- at Memorial Sloan-Kettering Cancer Center --

ZIOPHARM Commences Oral Indibulin Phase I/II Trial in Breast Cancer -- at Memorial Sloan-Kettering Cancer Center -- 18.1 KB NEW YORK, Apr 08, 2010 (BUSINESS WIRE) -- ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today it has initiated a Phase I/II study at Memorial Sloan-Kettering Cancer Center for the novel, mathematically - determined administration of oral indibulin (Zybulin(TM) or ZIO-301) in the treatment of metastatic breast cancer. The Phase I trial is expected to enroll approximately 20 patients and will determine the maximum tolerated dose of oral indibulin implementing the "mathematically modeled" dose administration schedule - 5 days on and 9 days off - that capitalizes on the convenience of oral administration, but also maximizes drug activity, limiting potential toxicity and resistance. Indibulin is a novel, oral tubulin binding agent that targets both mitosis and cancer cell migration. It is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy, and minimal overall toxicity . In multiple Phase I trials, oral indibulin has been administered both as a single agent and in combination with favorable activity, and has a promising safety profile that does not include the neurotoxicity seen with all of the other classes of tubulin binding agents. The trial will be continued into Phase II once dose has been established in Phase I. Clifford A. Hudis, M.D., Chief of the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center, noted, "The development of an additional new therapy for breast cancer that is effective but with fewer of the more significant side effects associated with many commonly used therapies would be an important step in the treatment of this disease. We look forward to testing this novel agent and dosing schedule in patients." The study will implement a mathematically modeled drug administration schedule that was developed in preclinical studies by Larry Norton, M.D. as a consultant to ZIOPHARM Oncology, Inc. The model capitalizes on the convenience and scheduling flexibility of oral administration to maximize anticancer activity, minimize potential toxicity and resistance, and exploit the drug's mechanisms of action on both cancer cell division and cell movement. Findings from the preclinical studies were presented at the 2009 American Society of Clinical Oncology annual meeting. Memorial Sloan-Kettering's Breast Cancer Medicine team, under the direction of Dr. Hudis, has successfully translated preclinical work into meaningful clinical treatment in past studies, and will lead this Phase I/II trial. For more details about this trial, please see www.clinicaltrials.gov . About ZIOPHARM Oncology, Inc.: ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer drugs. The Company is currently focused on three clinical programs. Palifosfamide (Zymafos TM or ZIO-201) references a novel composition (tris formulation) that comprises the functional active metabolite of ifosfamide, a standard of care for treating sarcoma, lymphoma, testicular, and other cancers. Palifosfamide delivers only the cancer fighting component of ifosfamide. It is expected to overcome the resistance seen with ifosfamide and cyclophosphamide, two of the most commonly used DNA-alkylating drugs used to treat cancers. Palifosfamide does not have the toxic metabolites of ifosfamide that cause the debilitating side effects of "fuzzy brain" (encephalopathy) and severe bladder inflammation. It may also have other advantages. Intravenous palifosfamide is currently in a randomized Phase II trial to treat unresectable or metastatic soft tissue sarcoma in the front- and second-line setting with the Company having reported interim positive results in late 2009; a registration trial in the same setting is expected to initiate following U.S. Food and Drug Administration (FDA) review in the first half of this year. An oral form of palifosfamide has been developed preclinically to the investigational new drug application stage. Darinaparsin (Zinapar TM or ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being developed for the treatment of various hematologic and solid cancers. Preclinical and clinical studies to date have demonstrated that darinaparsin is considerably less toxic than inorganic arsenic, particularly with regard to cardiac toxicity. The Company has reported favorable results from a Phase II trial with IV-administered darinaparsin in lymphoma, particularly peripheral T-cell lymphoma ("PTCL"), at the American Society of Clinical Oncology (ASCO) in May of 2009 which would serve as the basis for ongoing clinical study in PTCL following regulatory review and available financial resources. Phase I trials with an oral form are ongoing in both hematological malignancies and solid tumors. Indibulin (Zybulin TM or ZIO-301) is a novel, oral tubulin binding agent that targets both mitosis and cancer cell migration. In addition, indibulin is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and minimal overall toxicity . In multiple Phase I trials in cancer patients, oral indibulin has been administered both as a single agent and in combination with favorable activity and a promising safety profile that does not include the neurotoxicity seen with all of the other classes of tubulin binding agents. Results of oral indibulin in combination with oral capecitabine (Xeloda (R) ) were presented at last year's American Society of Clinical Oncology (ASCO) along with the preclinical findings of a novel dosing schedule conducted under the direction of Dr. Larry Norton. Employing this dosage schedule, the Company has initiated a Phase I study in breast cancer patients with the Breast Cancer Medicine Service at Memorial Sloan-Kettering Cancer Center. ZIOPHARM's operations are located in Boston, MA with an executive office in New York City. Further information about ZIOPHARM may be found at www.ziopharm.com . ZIOP-G 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, risks related to the Company's ability to protect its intellectual property and its reliance on third parties to develop its product candidates, risks related to the sufficiency of existing capital reserves to fund continued operations for a particular amount of time and uncertainties regarding the Company's ability to obtain additional financing to support its operations thereafter. The Company assumes no obligation to update these forward-looking statements, except as required by law. SOURCE: ZIOPHARM Oncology, Inc. ZIOPHARM Oncology, Inc. Tyler Cook, 617-259-1982 [email protected] or Media: Dennis S. Dobson, 203-258-0159 [email protected] Copyright Business Wire 2010

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