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ZIOPHARM Oncology Announces Promising Data From Phase 1b Study Of Palifosfamide In Small Cell Lung And Other Cancers At AACR-NCI-EORTC Meeting

“I am very enthusiastic about this investigational drug in SCLC. Ifosfamide, in combination with carboplatin and etoposide, is one of the few treatments to have demonstrated a survival advantage in SCLC, yet is often too toxic to be used effectively,” said Wael A. Harb, M.D., Medical Director of Clinical Research, Indiana University Health Arnett, Hoosier Oncology Group, and lead author. “The combination with palifosfamide appears to be well tolerated and has demonstrated promising clinical activity in SCLC, germ cell tumor and ovarian cancer. I look forward to participating in the confirmatory study in SCLC.”

“Based on past studies and my experience in SCLC, I am encouraged by these data and the potential of a combination regimen using palifosfamide, carboplatin and etoposide,” said Lawrence Einhorn, M.D., Distinguished Professor at the Simon Cancer Center of Indiana University Medical Center, Lance Armstrong Foundation Chair in Oncology, former President of ASCO and a member of ZIOPHARM's Medical Advisory Board. “Small cell lung cancer is a disease in desperate need of an effective treatment option, as the standard of care has remained unchanged after decades of research. These early data are not only an important step forward for palifosfamide in SCLC but also potentially other solid tumors.”

SCLC is almost exclusively associated with cigarette smoking and the majority of patients with extensive disease are treated front-line but relapse with a very high mortality within one year. According to the American Cancer Society, approximately 15 percent of lung cancers are SCLC, or an incidence of approximately 33,400 patients yearly in the U.S. There is expected to be a substantially growing incidence worldwide.

About ZIOPHARM Oncology, Inc.:

ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer therapeutics. The Company’s small molecule programs include:

Palifosfamide (Zymafos ® or ZIO-201) is a novel DNA cross-linker in class with bendamustine, ifosfamide, and cyclophosphamide and is currently in a randomized, double-blinded, placebo-controlled Phase 3 trial with palifosfamide administered intravenously for the treatment of metastatic soft tissue sarcoma in the front-line setting. The Company is also currently conducting a Phase 1 study of palifosfamide in combination with standard of care for addressing small cell lung cancer; an oral form of palifosfamide continues in preclinical study.

Darinaparsin (Zinapar ® or ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) currently in a solid tumor Phase 1 study with oral administration and has been developed intravenously for the treatment of relapsed peripheral T-cell lymphoma.

Indibulin (Zybulin™ or ZIO-301) is a novel, oral tubulin binding agent that is expected to have several potential benefits including oral dosing, application in multi-drug resistant tumors, no neuropathy and a quite tolerable toxicity profile. It is currently being studied in Phase 1/2 in metastatic breast cancer.

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