CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced updated results from its ongoing multicenter, randomized, open-label global Phase 2b clinical trial investigating the efficacy and safety of aldoxorubicin compared with doxorubicin as first-line therapy in subjects with metastatic, locally advanced or unresectable soft tissue sarcomas (STS). The updated trial results demonstrated that aldoxorubicin significantly increases progression-free survival (PFS), PFS at 6 months, overall response rate (ORR) and tumor shrinkage, compared to doxorubicin, the current standard-of-care, as a first-line treatment in patients with STS. The data trended in favor of aldoxorubicin for all of the major subtypes of soft tissue sarcomas. The results will be presented by Sant P. Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center, and principal investigator of the trial, in an oral presentation at the 2014 American Society for Clinical Oncology (ASCO) Annual Meeting, which is taking place May 30–June 3 in Chicago.
“These results indicate that aldoxorubicin is well tolerated and may improve clinical outcomes in patients compared to doxorubicin therapy, the current standard-of-care in this indication,” said Dr. Chawla. “This includes promising improvements in progression-free survival, tumor shrinkage and overall response rates in patients with a wide variety of soft tissue sarcomas. We are hopeful that the next stage of development for aldoxorubicin, a well-tolerated single agent that lacks the cardiotoxicity associated with doxorubicin therapy, will demonstrate its potential to meaningfully extend survival, and will lead to a new treatment option for patients fighting this aggressive, life-threatening cancer.”
“We are delighted that these results were selected for oral presentation at this year’s ASCO meeting,” said Steven A. Kriegsman, CytRx President and Chief Executive Officer. “We look forward to discussing the data with the oncology community and to reporting the full overall survival results from this trial in the second half of 2014. In parallel, we continue to actively enroll patients in our pivotal global Phase 3 trial in second-line STS. In that Phase 3 clinical trial, we are permitted to dose until progression, which could substantially enhance the benefit for sarcoma patients.”