Positive data from a Phase I study of palifosfamide (Zymafos? or ZIO-210) in combination with doxorubicin presented at the 45th Annual American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May 29th to June 2nd shows strong support for an ongoing Phase II Randomized Trial.
The Phase I trial of palifosfamide in combination with doxorubicin was fully enrolled with 13 patients, predominantly with soft tissue sarcoma and non-small cell lung cancer, and who had received a median of two prior therapies. Of 12 evaluable patients, there were 3 partial responses. Of the 8 patients with soft tissue sarcoma (STS) 75 percent had stable disease or better, with 2 having partial responses and 4 having prolonged stable disease. The median progression free survival (PFS) was 19 weeks.
The combination has proven to be easily administered and was well tolerated with no dose-limiting toxicities during a total of 73 cycles of treatment. Importantly, there were no reported events of encephalopathy, hemorrhagic cystitis or renal toxicity often associated with some current treatments for STS. Adverse events were primarily hematologic, including neutropenia and thrombocytopenia, and were managed easily. The pharmacokinetic evaluation in this trial indicates that palifosfamide exposure is comparable to that seen in murine models that resulted in marked synergy with doxorubicin.
Ziopharm Oncology, a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer drugs, is now enrolling into a Phase II randomized controlled trial comparing palifosfamide plus doxorubicin vs. doxorubicin in the front- and second-line treatment setting of STS. This is a multicenter, multinational trial in the United States and Europe. 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.”
Last editorial review: June 1, 2009.
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