CytRx To Start Phase 3 Trial Of Aldoxorubicin Under FDA's SPA

(RTTNews) - CytRx Corporation (CYTR), a bio-pharmaceutical company specializing in oncology, Monday said under a Special Protocol Assessment or SPA with the FDA, it has begun a pivotal global Phase 3 clinical trial to evaluate the efficacy and safety of its investigational drug aldoxorubicin, as a second-line treatment for patients with soft tissue sarcoma or STS. This multicenter, randomized, open-label Phase 3 clinical trial will enroll approximately 400 patients with metastatic, locally advanced soft tissue sarcomas, who have either not responded to, or have progressed following treatment with, one or more systemic regimens of non-adjuvant chemotherapies. Progression-free survival (PFS)will be the primary endpoint of the study while secondary endpoints will include overall survival, response rates and safety. The Phase 3 protocol has been agreed upon under a Special Protocol Assessment with the FDA, which agreed that the design and planned analysis of the study adequately addresses the objectives necessary to support a regulatory submission for approval. The clinical trial will be held at approximately 100 clinical sites in the U.S., Europe, Canada, Latin America, Asia Pacific and Australia.

Friday, the stock traded down 3.78 percent at $3.82, while in the pre-market, it gained 0.25 percent to $3.98 on the Nasdaq.