CytRx Says Wins FDA Acceptance for Protocol of Phase 2 Aldoxorubicin in Glioblastoma Trial

CytRx Corporation

, a biopharmaceutical research and development company specializing in oncology, today announced that additional preliminary data from its Phase 2b clinical trial demonstrating aldoxorubicin's potential advantage over doxorubicin in the treatment of soft tissue sarcoma (STS) will be presented at the 18^th Annual Connective Tissue Oncology Society (CTOS) Meeting on Thursday, October 31 at 4:30 p.m. Eastern time at the Sheraton New York Times Square Hotel. The Company previously reported that patients in the trial treated with aldoxorubicin had an Overall Response Rate (ORR) of 22%, whereas those administered the widely used chemotherapeutic agent doxorubicin had an ORR of 0%. The Company expects to report top-line data for the global Phase 2b clinical trial in December 2013. “Because CTOS draws thought leaders in the treatment of sarcoma from around the world, it provides an ideal forum to gain awareness of this compelling data and to acquaint the oncologists with our phase 3 study in patients with relapsed or refractory soft tissue sarcomas,” said CytRx President and CEO Steven A. Kriegsman. "Discoveries of new sarcoma treatments have been relatively few, particularly when compared with treatments for breast or prostate cancer, but the preliminary clinical results thus far drive our optimism that aldoxorubicin can fill an important medical need in patients with advanced soft tissue sarcoma. ” STS is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue, and can arise anywhere in the body at any age. There are more than 30 types of STS, and according to the American Cancer Society more than 10,500 new cases are diagnosed each year in the U.S. In addition to the Phase 2b trial for STS, the Company has received acceptance from the U.S. Food and Drug Administration (FDA) for a protocol to conduct a Phase 2 clinical trial with aldoxorubicin in glioblastoma, a difficult-to-treat and deadly brain cancer, and also plans to conduct a Phase 2 clinical trial in HIV-related Kaposi's sarcoma.