8:31AM CytRx announces agreement with FDA on special protocol assessment for global pivotal phase 3 clinical trial with aldoxorubicin for soft tissue sarcoma (CYTR) 2.82 : Co announced today that it has reached an agreement with the FDA under a special protocol assessment for a global pivotal Phase 3 trial with aldoxorubicin as a treatment for patients with soft tissue sarcomas who have relapsed or were refractory following prior treatment with chemotherapy. The SPA is a written agreement between the Company, as the trial's sponsor, and the FDA regarding the design, endpoints and planned statistical analysis approach of the Phase 3 clinical trial to be used in support of a potential New Drug Application for aldoxorubicin. The Company is actively making preparations for the pivotal Phase 3 trial.
In the Phase 1b/2 clinical trial in patients with advanced soft tissue sarcoma treated with aldoxorubicin in up to eight cycles at the maximum tolerated dose, 77% (10 of 13) of the evaluable patients showed clinical benefit, defined as partial response with tumor shrinkage in excess of 30% or stable disease at four months following treatment. None
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