Ziopharm has reported that the enrollment in the palifosfamide (Zymafosk or ZIO-201) phase II trial in metastatic or unresectable soft tissue sarcoma, continues in a planned manner.
Reportedly, the objective of the phase II trial is to generate data in a randomized controlled setting that would serve as a basis for conferencing with the FDA on the design of a registration trial, a study the company expects could initiate as early as the first half of 2010.
The company will also plan to review the phase II darinaparsin (Zinapar or ZIO-101) study results in lymphoma with the FDA, with the intent of conducting a registration trial in T-cell lymphoma, also as early as the first half of 2010.
In addition to that, the oral darinaparsin phase I trials would be continued to maximum tolerated dose with a focus on lymphoma.
Similarly, oral indibulin (Zybulin or ZIO-301) is scheduled to enter into a phase I/II study in breast cancer patients. The trial would use the Norton-dosing schedule developed preclinically in collaboration with Larry Norton, and initiating in 2009 with the teams of Clifford Hudis in the US and Jose Baselga in Spain.