Ziopharm Oncology, Inc announced that the first patient has been dosed in its international phase-II randomized controlled trial of palifosfamide (ZIO-201) in patients with soft-tissue sarcoma (STS): This is a phase-II multi-centre, parallel group, randomized study of palIfosfamide plus doxorubicin versus doxorubiCin in subjects with unresectAble or metastatic Soft-tissue SarcOma (PICASSO). Approximately 100 evaluable subjects are expected to be enrolled in this multi-center trial, which is being conducted at sites in the U S and Europe by several key opinion leaders in sarcoma.

This phase-II trial will evaluate the clinical benefit of palifosfamide administered with doxorubicin compared with single-agent doxorubicin in subjects diagnosed with unresectable or metastatic STS in the front- or second-line treatment setting. The primary endpoint is assessment of the difference in progression-free survival between subjects in the two arms of the trial.

Sant P Chawla, director, Sarcoma Oncology Center, Santa Monica, and one of the lead investigators of the study noted, "I am delighted to announce the dosing of the first patient in this key combination trial for palifosfamide in front- and second-line patients following very promising results in previous trials in sarcoma in the refractory setting. By conducting a randomized controlled phase-II trial where the primary endpoint is progression-free survival, Ziopharm has optimized its chances of yielding positive results by aiding in the design and thereby mitigating risk for a phase-III pivotal trial to follow."

In May 2008, Ziopharm received Orphan Drug Designation from the U S Food and Drug Administration (FDA) for palifosfamide in the treatment of STS.

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 the development of three clinical programs for multiple indications.