ZIOPHARM Oncology, Inc., a biopharmaceutical company, has started a multi-centre, single arm phase II investigator-sponsored study of palifosfamide (ZIO-201) in patients with recurrent metastatic germ cell (testicular and ovarian) tumours who have relapsed on initial platinum-based therapy and high dose chemotherapy, or patients who are not eligible for high dose chemotherapy.

The study is being conducted at the Melvin and Bren Simon Cancer Centre at the Indiana University, led by Lawrence Einhorn, MD, Distinguished Professor of the Department of Medicine, Division of Haematology/ Oncology at the School of Medicine.

ZIOPHARM is currently conducting phase III trials of palifosfamide in first-line metastatic soft tissue sarcoma (PICASSO 3) and first-line metastatic small cell lung cancer (MATISSE). Dr Einhorn is the lead principal investigator for the MATISSE trial. The Company expects to announce topline results from PICASSO 3 the last week of this month.

"While treatments for germ cell cancers are often effective, and five-year survival is high, there remains a population for whom relapse or a lack of tolerability lead to poor prognosis," said Dr Einhorn. "Palifosfamide is in the same molecular class as ifosfamide, an agent that has transformed the treatment of testicular cancer. Our early experience in phase I testing with palifosfamide in patients with resistant testicular and ovarian germ cell tumors is quite encouraging. Data from the phase II study will inform us of how best to advance the use of palifosfamide in these diseases."

The primary endpoint is response rate (CR+PR) of single agent palifosfamide in patients with refractory germ cell tumours. The secondary endpoints include the duration of remission, progression-free survival (PFS), overall survival (OS) and the safety profile of palifosfamide in patients with germ cell tumors. In this trial, twelve patients will be treated with palifosfamide (150 mg/m2 3 days every 3 weeks for 6 cycles) and, if at least 1 response (RR of = 8.5%) is observed, enrollment will continue to a total of twenty patients to evaluate response rate of single agent palifosfamide. Additionally, the response rate will be assessed every cycle by RECIST v1.1 and by serum AFP and beta-hCG.

ZIOPHARM Oncology is focused on the development and commercialization of new cancer therapies.