CytRx says had positive meeting with FDA to discuss potential Phase 3 trial

theflyonthewall.com

The company announced that it has held a positive meeting with the FDA to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. “We are planning to submit a special protocol assessment for the Phase 3 trial in patients with advanced soft tissue sarcomas,” said President and CEO Steven A. Kriegsman. “An agreement with the FDA with regards to an SPA would provide a clear regulatory pathway through the approval process. The initiation of a Phase 3 program for our lead drug candidate aldoxorubicin would represent a significant milestone in CytRx’s efforts to bring value to our stockholders and for those patients suffering from soft tissue sarcoma.”

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