USA and China-based Zensun Science & Technology has revealed positive results of four completed Phase II clinical trials including three double-blind, placebo-controlled studies conducted in China and Australia and interim results from the US Phase II trial for Zensun's innovative "first-in-class" anti-heart failure drug, Neucardin, which has just been licensed to the USA’s SciClone Pharmaceuticals (Nasdaq: SCLN) for Greater China (The Pharma Letter May 20).
The data demonstrates that Neucardin reduced all-cause mortality, improved heart function, reduced heart volumes, improved exercise capacity and quality of life on top of current standard of care in patients with chronic heart failure (CHF). Based on these clinical trial data, Zensun has filed a New Drug Application in China to obtain accelerated market approval, and is planning a Phase III clinical program in the USA.
"Current treatments for chronic heart failure have improved mortality; however, they have reached their potential and novel therapeutic approaches are required if outcomes in these patients are to improve," said Inder Anand, a steering committee member for the US clinical trial, and Professor of Medicine at the University of Minnesota and Director of the Heart Failure Program at the Minneapolis VA Medical Center. "Neucardin has truly novel mechanisms of action on the failing heart. It targets diseased heart tissue directly via two alternate pathways; one that promotes heart muscle's structural integrity and the other improves the pumping efficiency of the heart," he added.
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