Ziopharm Reveals Results Of Phase 2 Sarcoma Trail

The randomised phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting.

Patients are randomised either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin.

In the study, there were 67 patients randomised to the trial, with 65 treated and 61 eligible for analysis.

The 61 patients were evaluated for progression-free survival (PFS) with 20 documented PFS events (doxorubicin alone = 14 events; palifosfamide + doxorubicin = 6 events).

With this analysis of all randomised and eligible patients, the hazard ratio is 0.63 favoring palifosfamide + doxorubicin, statistically supporting that palifosfamide prolongs PFS by at least 50%.

The arms of the trial were very well-balanced by predetermined stratification in terms of Age and Pre-selected histopathological subtypes. In addition, and consequently, this also resulted in balance between front- and second-line patients.

The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin.

The most frequently reported side effects in both arms of the study include neutropenia and fatigue, hypokalemia, nausea, anemia, leucopenia, and alopecia.

Palifosfamide is easily administered as an out-patient treatment, and generally well-tolerated.

The company is in the process of finalising a registration trial plan in soft tissue sarcoma for review by the appropriate US and international regulatory authorities.