Clinical benefit with INNO-206 at the maximum tolerated dose was shown in 10 of 13 (76.9%) evaluable patients with relapsed or refractory soft tissue sarcoma.
In addition, five achieved partial response, as defined as tumor shrinkage of more than 30%, seven showed prolonged stable disease, eight had tumor shrinkage and five of eight patients who demonstrated either partial responses or prolonged stable disease after treatment with INNO-206 had been previously treated with doxorubicin and had failed to respond.
Median estimated progression-free survival for advanced soft tissue sarcoma patients in the trial was 6.4 months with a range of 1.0 to more than 10.7 months.
CytRx president and CEO Steven Kriegsman said in light of the strength of the results and the fact that there are only limited approved therapies for patients with advanced soft tissue sarcomas and the company plans to meet with the FDA to discuss a Phase 3 pivotal trial design with INNO-206 as a third-line therapy in soft tissue sarcoma patients.