CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, presented updated progression-free survival (PFS) and overall survival (OS) results from its completed Phase 1b/2 clinical trial of aldoxorubicin in patients with advanced soft tissue sarcoma (STS). The data were presented as part of CytRx’s Research and Development Day which took place Friday, May 2, 2014 at the Harvard Club in New York City.
Data from the Phase 1b/2 trial demonstrated that aldoxorubicin administered at its maximum tolerated dose (350mg/m
) showed a substantial increase in median PFS in patients with advanced soft tissue sarcoma (n=13). Partial responses were observed in 5 of 13 patients (38%) and stable disease was observed in 6 of 13 patients (46%). Median PFS of 6.4 months was initially reported at ASCO and ESMO; in the final reported data, observed median PFS had nearly doubled to 11 months, and median OS was 17 months. Notably, following 8 cycles of aldoxorubicin, two patients experienced no progression of disease for 23 and 15 months, respectively, despite no further treatment. Aldoxorubicin was generally well tolerated with no observed cardiotoxicities and no drug-related deaths.
“The data from this now completed study are certainly a promising advance and show that aldoxorubicin was clinically active and generally well tolerated in patients who are particularly difficult to treat given the advanced stage of their disease,” said Sant P. Chawla, M.D., F.R.A.C.P., principal investigator of the trial and renowned sarcoma expert. “There remains a high unmet need for patients with soft tissue sarcoma, especially since many relapse or stop responding to currently available treatments. I am also particularly encouraged by the long progression-free periods experienced by two patients in this study.”
“We are excited to see that the final data showed substantial improvement in median PFS over the previously-reported data, as well as impressive median overall survival. Importantly, the data from the Phase 1b/2 trial came after the administration of only 8 cycles of aldoxorubicin – for future clinical development, we are permitted to dose until progression, which could substantially extend the lives of sarcoma patients. We are actively enrolling patients in our pivotal global Phase 3 clinical trial in second-line STS and we look forward to keeping you updated on our progress,” said Steven A. Kriegsman, CytRx President and Chief Executive Officer. “We would like to thank Dr. Chawla for his tireless work with aldoxorubicin as a novel treatment candidate for sarcoma.”