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AMR–001: First stem cell product to demonstrate in a clinical trial a dose–related improvement in cardiac perfusion
AMR–001 is Amorcyte’s lead product for the treatment of damaged heart muscle following AMI. An autologous bone marrow derived, CD34
positive selected stem cell product, AMR–001 limits the damage of heart muscle that develops following AMI and, thus, has the
potential to limit ventricular remodeling. Furthermore, treatment with AMR–001 fits seamlessly into physicians’ standard treatment
practices. Administered in the catheterization laboratory as an out–patient procedure, AMR–001 is a simple addition to the standard of care.
In a recently completed Phase I study of 31 patients, AMR–001 showed a dose–related significant improvement in perfusion. Presented
at the 2009 American College of Cardiology Annual Scientific Session, the Phase I study results demonstrated that patients receiving
10 and 15 million cells (n=9) showed significant improvement in resting perfusion rates at six months as compared to patients receiving
5 million cells (n=6) and control (n=15), as measured by the SPECT total severity score, (–256 versus +13, p=0.01). The data also showed
that patients receiving 10 or more million cells showed a trend towards improvement in ejection fraction, the percentage of blood pumped
out of a ventricle with each heartbeat, (+4.5% versus +0.69%); end systolic volume (–5.7mL versus +3.5mL); and infarct size, tissue death
due to loss of adequate blood supply, (–7.4% versus –5.3%) at six month follow–up. No study–related significant adverse
events were reported.
Amorcyte expects to commence a larger prospective randomized Phase II trial with AMR–001 in 2009
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