| ZIOPHARM Oncology presented at the 15th Annual Connective Tissue Oncology Society Meeting, positive interim data from the multicenter randomized Phase II trial of palifosfamide treating patients with unresectable or metastatic soft tissue sarcoma. As previously announced, having achieved the study-specified efficacy milestone following planned safety and efficacy review by the Data Committee, a panel of international sarcoma experts, and the Company’s Medical Advisory Board, it was determined that the data are compelling and sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial. The randomized Phase II trial treats patients with unresectable or metastatic soft tissue sarcoma in the front- and second-line setting. Patients are randomized either to doxorubicin 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 with 20 documented PFS events. With this analysis of all randomized and eligible patients, the hazard ratio is 0.63 favoring palifosfamide + doxorubicin, statistically supporting that palifosfamide prolongs PFS by at least 50%. :theflyonthewall.com |
Subscribe for More Information