Success in Phase I Trial of Palifosfamide from ZIOPHARM Oncology Inc. Will Push it Into Phase II (ZIOP)
ZIOPHARM Oncology Inc. (Nasdaq: ZIOP) announced recently that it presented the final data from a Phase I study of palifosfamide (ZymafosTM) in combination with doxorubicin at the Annual American Society of Clinical Oncology (ASCO). ZIOPHARM ended trading on June 4th up 0.24 (16.23%) with a closing price $1.74.
Palifosfamide (ZymafosTM or ZIO-201) comprises the functional active metabolite of ifosfamide, used in treating sarcoma, testicular and other cancers. It is expected to overcome the resistance of ifosfamide and cyclophasphamide in certain cancers. It does not have the toxic metabolites of ifosfamide that cause the debilitating side effects of encephalopathy and severe bladder inflammation.
The combination of palifosfamide and doxorubicin during the phase I trial has proven to be easily administered and was well tolerated with no dose-limiting toxicities during a total of 73 cycles of treatment.
Enrollment in a Phase II trial is forthcoming – comparing palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (STS). The objective of the randomized Phase II trial is to validate certain hypotheses that would form the basis for a registration trial to be initiated as early as the first half of next year.
“These highly favorable Phase I data of palifosfamide in combination with doxorubicin established the foundation for the now ongoing Phase II randomized trial in the front and second-line setting”, commented Sant Chawla, MD, co-principal investigator. “Data has previously been reported on the activity of palifosfamide as a single agent in advanced sarcoma as well as the established synergy of palifosfamide with doxorubicin preclinically. With so few treatment options, I look forward to ZIOPHARM initiating the final phase of the drug development program that could establish the first new front-line sarcoma therapy in decades and as well to advancing into the clinic an oral form for much expanded patient access.
Joshua Sherman
