Ziopharm plummets on palifosfamide miss

Ziopharm Oncology Inc. (NASDAQ:ZIOP) fell $3.31 (65%) to $1.82 on Tuesday after the company discontinued development of Zymafos palifosfamide as first-line treatment of soft tissue sarcoma (STS). The move came after IV Zymafos plus doxorubicin missed the primary endpoint of improving progression-free survival (PFS) vs. doxorubicin alone in the Phase III PICASSO 3 trial in 447 anthracycline-naïve patients with metastatic STS. Ziopharm said it does not plan to follow patients to evaluate the secondary endpoint of overall survival (OS). Zymafos is a stabilized formulation of the active metabolite of ifosfamide, a bifunctional DNA alkylating agent.

Based on the results, Ziopharm said it will restructure to exclusively focus on its synthetic biology programs, including lead candidate Ad-RTS-IL-12, a DNA vector that contains an inducible promoter to control expression of the IL-12 gene. Ziopharm also said it will downsize the ongoing Phase III MATISSE trial of Zymafos as first-line treatment of metastatic small cell lung cancer (SCLC) to a Phase II trial to conserve spending for its synthetic biology programs. At Dec. 31, 2012, Ziopharm had $73.3 million in cash and a full-year operating loss of $103 million. With the restructuring, Ziopharm said it now expects to extend its cash runway for "significantly longer" than into 2H13, but said it is premature to give an exact time frame. ...