Ziopharm Presents Positive Palifosfamide Sarcoma Randomized Phase II Interim Data

Published: 06-Nov-2009

Palifosfamide prolongs progression-free survival by at least 50%

Ziopharm has presented positive interim data from the multicenter randomized Phase II trial of palifosfamide (Zymafos, ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma.

The randomized Phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting. Patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin.

The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The most frequently reported side effects in both arms of the study include neutropenia and fatigue, hypokalemia, nausea, anemia, leucopenia, and alopecia. Palifosfamide is easily administered as an out-patient treatment, and generally well-tolerated.

George Demetri, director of Center for Sarcoma and Bone Oncology and Ludwig Center at Dana-Farber Cancer Institute and Harvard Medical School, said: “These interim results are very promising, indicating a potentially new drug to help control this life-threatening disease with acceptable safety and quality of life.”

Lawrence Einhorn, professor at Simon Cancer Center of Indiana University Medical Center, said: “These data are not only encouraging for sarcoma but hopefully palifosfamide may also work in treating other cancers. This is particularly interesting if the oral form is successful in the clinic.”

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