ISS&ISE Reports Have Been Submitted to the FDA
Zensun has achieved a major corporate milestone for Neucardin clinical development by submitting the Integrated Summary of Safety (ISS) and Integrated Summary of Effectiveness (ISE) to the FDA on Dec. 18, 2017 as planned.
These ISS and ISE reports were prepared in response to FDA’s Advice/Information Request prior to initiating additional clinical studies with Neucardin. The mission is a huge undertaking due to legacy studies (Phases 1 through 3) conducted in China, Australia and US over 10 years of development.
Efficacy analyses (ISE) suggest chronic HF subjects with less severe chronic HF may benefit most from Neucardin therapy. Based upon available safety information, Zensun believes the overall safety profile of Neucardin is adequate to support future clinical studies with Neucardin in these subjects with recommendations.
According to Dr. Lei Zhang, VP of global Clinical Development & Operations at Zensun USA, Inc., who led the team for this submission since its inception, more than 150 people around the world with multi-disciplinaries have been involved in the ISS & ISE project over the period of 2 years. The collaboration with Parexel International (a global CRO) has led to a fruitful execution for this ISS & ISE submission.
Zensun is currently engaging plans for the Phase 3 multi-center global clinical study to be conducted under the IND.