Zymafos palifosfamide: Development discontinued

Ziopharm discontinued development of Zymafos as first-line treatment of STS after the double-blind, international Phase III PICASSO 3 trial in 447 anthracycline-naïve patients with metastatic STS showed that IV Zymafos plus doxorubicin missed the primary endpoint of improving PFS vs. doxorubicin alone. Although recommended by the study's IDMC, Ziopharm said it does not plan to follow patients to evaluate the secondary endpoint of OS. Zymafos plus doxorubicin was well tolerated. The company said full data from PICASSO 3 will be submitted for publication in a scientific journal.

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 12-month operating loss of $103 million. In its 2012 earnings reported March 18, the company said it expected its cash to support operations into 2H13. 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. ...