August 19, 2011 — NeoStem Inc., an international biopharmaceutical company, reported progress toward commencement of a Phase II clinical trial for AMR-001 for the treatment of acute myocardial infarction. The stem cell product is from Amorcyte Inc., a NeoStem subsidiary.
The company is confident trials will commence ahead of schedule thanks to the product’s positive movement through the U.S. Food and Drug Administration (FDA) drug development process.
AMR-001 is an autologous stem cell treatment designed to prevent major adverse cardiac events following acute myocardial infarction (AMI). Andrew Pecora, M.D., chief scientific officer for Amorcyte, said, "We believe that there are data from several published clinical trials, including ours, demonstrating the potential effectiveness of a cell-based therapy for preserving cardiac function and preventing the adverse clinical events that usually follow a large myocardial infarction. Our clinical trial of AMR-001 yielded significant results, forming the basis for the Phase II trial. AMR-001 is a homogeneous, purified and enriched cell population for which investigators have established a biologically active, or threshold, dose."
The Phase II trial has been designed to provide a clear picture of the potential to improve perfusion, preserve cardiac function and improve clinical outcomes. It is expected to include 150 patients in a placebo-controlled, double blind study. This design replicates that of the Phase I trial, but with substantially greater statistical power. A composite of cardiac measures, including clinically meaningful endpoints, will support the primary endpoint of perfusion. "Though the plan was to enroll the first patient early in 2012, we are now confident that we will begin the Phase II program ahead of schedule," said Pecora.
Progenitor cell therapy (PCT) capabilities in quality cell manufacturing are a key advantage in the development of AMR-001 as well as future cell-based therapeutics candidates the company may pursue.
For more information: www.neostem.com