An International Multi-center Phase III Clinical Trial of Recombinant Human Neuregulin-1 is going to Launch
After obtaining agreement from the FDA, Zensun is preparing to launch an international multi-center phase III clinical trial in the near future. The study will enroll patients in about 150 hospitals in 10 countries, including the US, China, and several European countries. The trial is designed to be a randomized, parallel, placebo-controlled, double-blind, international multi-center registration study to evaluate the efficacy of Recombinant Human Neuregulin-1 in Chronic Heart Failure (CHF) subjects for improvements in a composite primary endpoint consisting of cardiovascular mortality and recurrent HF hospitalization. It is anticipated that the trial will be completed within about 2 years. Data from previous studies by Zensun …
Therapy for Chronic Heart Failure
Recombinant human neuregulin-1(NEUCARDIN; rhNRG-1)
Neucardin™ is a portion of a protein known as Neuregulin-1 which is found in the heart.
Neucardin™ is currently in Phase III clinical trials in China and has completed Phase II clinical trials in China, Australia and the United States. And it has been authorized to perform Phase III clinical trials in the US by FDA at the end of 2013.
Zensun is developing a novel treatment for Chronic Heart Failure (CHF), a syndrome where the heart is unable to supply sufficient blood flow to meet the needs of the body. CHF affects 5 million people in the United States. There are no treatments for CHF other than heart transplantation...
US Clinical trial of rhNRG-1 is enrolling heart failure patients with NYHA Classification II and III.