ZIOPHARM Oncology Inc. (ZIOP) announced that the Independent Data Monitoring Committee or IDMC has unanimously recommended continuation of the international, randomized, double-blinded, placebo-controlled Phase 3 trial or PICASSO 3 of palifosfamide (Zymafos or ZIO-201) in front-line metastatic soft tissue sarcoma.
Targeted completion of enrollment for PICASSO 3 is expected by the end of the first quarter of 2012. The outcome in progression-free survival, the study's primary endpoint for accelerated approval, is anticipated in the second half of 2012.
Palifosfamide 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 said.
The company said that it 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.
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