(NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today reported positive results from additional statistical analyses that further support the previously announced highly positive top-line efficacy results from a 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).
Additional analysis determined hazard ratios for the primary endpoint of progression-free survival (PFS) by both investigators at study sites and by a blinded radiology review performed at an independent central laboratory. The hazard ratio for investigator-read scans is 0.37 (95% confidence interval, range of 0.212 to 0.643) (p=0.0004), reflecting a 63% reduction in the risk of disease progression; and the hazard ratio for central lab scans is 0.59 (95% confidence interval, range of 0.36 to 0.96) (p=0.034), reflecting a 41% reduction in the risk of disease progression. Hazard ratios – the likelihood that the study endpoint (in this case tumor progression) will be reached during a given period – are an important measure of the reliability and uniformity of the absolute data for PFS, as presented below. Hazard ratios where the upper limit is less than 1 indicate that there is a significant difference between the two study groups.
CytRx also reported that a Kaplan-Meier analysis of the trial results, which describes the time it takes for tumors to progress in individual patients, showed significant improvement in subjects treated with aldoxorubicin versus subjects treated with doxorubicin. CytRx expects to present full study results for this clinical trial at the American Society for Clinical Oncology (ASCO) Meeting in June, 2014 in Chicago, Illinois.
CytRx President and CEO Steven A. Kriegsman commented, “Because of the tremendous potential for aldoxorubicin to treat soft tissue sarcomas and other common cancers, it is important that we present the initial trial analyses in a timely manner. We are very pleased that additional statistical analyses strongly support the earlier top-line results, which reinforces our confidence in the ability of our linker technology to target the release of doxorubicin directly at the site of cancer.”