Stem cell drug (AMR-001) to treat damage heart muscle successfully completed Phase I clinical trials
This is the first stem cell trial in acute myocardial infarction (AMI)ever conducted that has prospectively established a significant relationship between dose and effect.
Stem cell drug AMR-001 is the lead product of Amrocyte Inc., a privately held biotechnology company developing cell therapy products to treat cardiovascular disease.
AMR-001, is aimed for the prevention of major adverse cardiac events following acute myocardial infarction , has completed Phase I clinical trials demonstrating feasibility, safety and biologic activity at a threshold dose.
This is the first and only study to prospectively define a dose of a purified and potent autologous stem cell therapy (AMR-001) that resulted in a significant improvement in perfusion, a trend towards improved cardiac function and the potential to reduce subsequent adverse cardiac events following AMI.
The study results showed that patients receiving 10 to 15 million cells experienced significant improvement in resting perfusion rates at six months as compared to patients receiving 5 million cells. No study-related significant adverse events were reported.
Andrew Pecora, M.D., Chairman of the Board of Amorcyte, is highly encouraged with the strong Phase I results, having successfully confirmed a dose effect, Amorcyte is looking forward to proceeding with a larger prospective randomized trial and furthering their clinical program with AMR-001.