Ziopharm's palifosfamide fails to meet endpoint in Ph III study

26 March 2013

US drug developer Ziopharm Oncology (Nasdaq: ZIOP) saws its shares plunge $3.21 to $1.92 after it said its Phase III trial of palifosfamide (ZIO-201) - its lead product candidate - for the treatment of metastatic soft tissue sarcoma in the first-line setting (PICASSO 3) did not meet its primary endpoint of progression-free survival (PFS).

The study's independent data monitoring committee (IDMC) has recommended that patients be followed for overall survival (OS), the study's secondary endpoint, however the company does not expect to continue follow up for OS. Palifosfamide was well tolerated, with a safety profile in combination with doxorubicin observed in the study comparable with other palifosfamide clinical trials in soft tissue sarcoma. Full data from PICASSO 3 will be submitted for publication in a scientific journal.

Will now focus on synthetic biology programs

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