CytRx (CYTR) Completes Aldoxorubicin Phase 2b Enrollment in SCLC

September 7, 2016 9:10 AM EDT

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CytRx Corporation (Nasdaq: CYTR) announced that it has reached its enrollment target of 132 patients for the company's global Phase 2b clinical trial of aldoxorubicin in patients with previously treated small cell lung cancer (SCLC). The Phase 2b study is a randomized, comparative trial being conducted at 41 sites in the United States, Hungary and Spain.

"Patients with metastatic small cell lung cancer who have relapsed or are refractory to first-line chemotherapy have few treatment options," said Steven A. Kriegsman, Chairman and CEO of CytRx. "Aldoxorubicin represents a potential new therapy to combat this aggressive form of cancer. The Phase 2b trial uses a lower dose of aldoxorubicin than our Phase 3 trial in soft tissue sarcoma, which may improve the tolerability and potentially allow patients to stay on treatment longer. We look forward to reporting the trial results once they are available."

Because of the unmet medical need for patients with second-line SCLC, if the global Phase 2b clinical trial results are positive, CytRx intends to meet with the U.S. FDA to discuss the regulatory pathway for the submission of a New Drug Application for aldoxorubicin in this patient population.

Trial Design

The multicenter, randomized, open-label, global Phase 2b clinical trial enrolled 132 patients with metastatic SCLC who either did not respond to, or who progressed following treatment with one systemic therapy. Trial patients were randomized 1:1 to be treated with aldoxorubicin at a dose of 230mg/m2 (170mg/m2 of doxorubicin equivalents) or standard dose topotecan. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival, response rates and safety.

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