Ziopharm Oncology, Inc. achieved positive data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) in patients with unresectable or metastatic soft tissue sarcoma.
Having achieved the study’s efficacy milestone following safety and efficacy review, it was determined that the data is sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial.
In the Phase II trial, patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of the October 5th cut-off date, there were 67 patients randomized to the trial, with 65 treated and 61 eligible for analysis. The 61 patients were evaluated for progression-free survival (PFS).
The median (PFS) for doxorubicin is 4.4 months, the median PFS for palifosfamide + doxorubicin has not yet been reached; the 1st PFS was 1.5 months for doxorubicin vs. 3.5 months for palifosfamide + doxorubicin. PFS is a biologically important end point in sarcoma, and has been well demonstrated to be a relevant measurement of the effect of treatment on outcome.
The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The company is in the process of finalizing a registration trial plan in soft tissue sarcoma for review by regulatory authorities.
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