(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced the presentation today of favorable results from a Phase 1b/2 clinical trial with its tumor-targeting doxorubicin conjugate aldoxorubicin (formerly INNO-206) in patients with advanced soft tissue sarcoma at the Connective Tissue Oncology Society (CTOS) 17
Annual Meeting in Prague, Czech Republic. The poster-discussion presentation was delivered by Dr. Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, California.
“We concluded from the trial data that aldoxorubicin is an active drug for the treatment of patients with metastatic soft tissue sarcomas who have progressed on prior chemotherapies, including those previously treated with doxorubicin,” said Dr. Chawla, a world renowned expert in the treatment of soft tissue sarcomas who served as the trial’s principal investigator. “Patients treated with aldoxorubicin in this clinical trial were delivered doxorubicin in a cumulative dose of more than 3½ times the peak cumulative dose of standard doxorubicin with no observed cardiac toxicities, even though cardiac safety is considered one of the dose-limiting side effects for standard doxorubicin.”
The Phase 1b/2 trial data showed clinical benefit (defined as partial response and stable disease of more than four months following up to eight cycles of treatment) with aldoxorubicin at the maximum tolerated dose in 10 of 13 evaluable patients with advanced soft tissue sarcomas. The data were first announced in early June 2012 at the American Society of Clinical Oncology (ASCO) conference in Chicago and also were presented at the European Society of Medical Oncology (ESMO) 2012 Congress in Vienna, Austria in October 2012.
CytRx President and CEO Steven A. Kriegsman said, “Data from this and other trials strongly indicate that aldoxorubicin warrants further investigation in this indication. We recently held a positive meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 pivotal trial with aldoxorubicin as a therapy for patients with soft tissue sarcomas whose tumors have progressed following treatment with chemotherapy. Last week we announced that we are submitting a special protocol assessment (SPA) with respect to this potential trial.”