Amorcyte Presents Results of Stem Cell Study at ACC on Improved Blood Circulation After Severe Heart Attack

First Stem Cell Trial to Show Dose-related Significant Improvement in Perfusion

Orlando, Fla, March 30, 2009 –Amorcyte, Inc. (Amorcyte) today announced data from its Phase I clinical trial of AMR-001, the company’s lead product for the treatment of damaged heart muscle following acute myocardial infarction (AMI), that showed a significant relationship between cell dose and biologic effect. 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 findings were presented at the American College of Cardiology (ACC) Annual Scientific Session.

The 31 patients in the Phase I trial were randomly assigned to an autologous stem cell harvest group (cells were harvested from the patient’s own bone marrow) or control group five days after an ST elevation myocardial infarction (STEMI) characterized by a prolonged period of hypoperfusion (blocked blood supply).  CD34+ cells were then isolated from the bone marrow, and enriched to increase potency using the company’s patented technology into five, 10 and 15 million cell doses.  The cells were infused via the infarct-related artery seven to 11 days following the STEMI – the optimal time frame to attempt to prevent adverse ventricular remodeling.  Caused by the progressive decline in heart muscle function following an AMI, ventricular remodeling can lead to permanent heart damage and increase the risk of recurrent heart attack, other adverse cardiac events and death. 

The study results showed that patients receiving 10 to 15 million cells (n=9) experienced 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).  Further, 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% versus +1%); end systolic volume (-5.7mL versus -0.1mL); and infarct size, tissue death due to loss of adequate blood supply, (-10% versus -3%) at six month follow-up.  No study-related significant adverse events were reported.

“We are very encouraged that our latest findings continue to show the potential for a patient’s own stem cells to reduce serious long-term complications from a heart attack,” said Arshed Quyyumi, M.D., FRCP, FACC, Professor of Medicine, Cardiology, at Emory University School of Medicine and the trial’s principal investigator.  “This study has potentially set an important dosing threshold that offers greater protection against future down-stream adverse events, with no impact on the safety profile.  Importantly, the treatment regimen is such that there is no change to our standard treatment practices.  We look forward to beginning a Phase II trial.” 

Of the 1 million heart attacks in the U.S. each year, nearly 20% are severe enough to cause ventricular remodeling. Amorcyte’s patented technologies and cGMP (current good manufacturing practices) manufacturing processes address the therapeutic and commercial challenges to post-MI stem cell treatment. Unlike other approaches, Amorcyte’s technology has established cell product identity, purity, dose and potency, along with sterility and product shelf-life. 

A previously published meta-analysis1 of prior clinical trials, which included a cumulative 698 patients who received intracoronary autologous cell therapy after AMI, showed a significant improvement in ejection fraction, end systolic volumes, infarct size, reduction in subsequent MI’s, and trends towards reduced deaths, admissions for heart failure and need for repeat vascularization. Strikingly, this analysis found a significant association between injected cell volume and improvement in ejection fraction that is suggestive of a dose effect.  This summation of prior studies supports Amorcyte’s subsequent prospective findings.

“Having successfully confirmed a dose effect, Amorcyte looks forward to proceeding with a larger prospective randomized trial and furthering our clinical program with AMR-001,” said Andrew Pecora, M.D., Chairman of the Board of Amorcyte. “These strong Phase I results, combined with proprietary innovative technologies that address the challenges of commercializing stem cell products, position us to bring to market a stem cell therapy with the potential to address a serious unmet patient need.”  

About Cardiovascular Disease
It is estimated that each year there are approximately 1.1 million instances of acute myocardial infarction (AMI).  160,000 AMIs are severe enough to cause ventricular remodeling leading to further tissue damage over time and downstream adverse events including premature death, recurrent myocardial infarction, congestive heart failure, significant arrhythmias and acute coronary syndrome.  Amorcyte’s therapy aims to limit ventricular remodeling.

About Amorcyte, Inc.
Amorcyte is a privately held biotechnology company developing cell therapy products to treat cardiovascular disease.  Its lead product AMR-001, for the prevention of major adverse cardiac events following acute myocardial infarction (AMI), has completed Phase I clinical trials demonstrating feasibility, safety and biologic activity at a threshold dose.  This is the first stem cell trial in AMI ever conducted that has prospectively established a significant relationship between dose and effect.  Amorcyte has partnered with Progenitor Cell Therapy, a leading provider of clinical, manufacturing and other services for the cell therapy industry, to provide Amorcyte with a pharmaceutical grade cGMP manufactured product that can be distributed commercially.  Amorcyte was founded by Andrew Pecora, M.D., Chairman of Hackensack University Cancer Center, with initial investment by Novitas Capital and Colt Ventures.  Additional information about Amorcyte can be found at: www.amorcyte.com.

1 Lipinski M et al J Am Coll Cardiol 2007: 50: 1761

 

Eric Goldman

Rx Communications Group

egoldman@rxir.com

917-322-2563
 

Posted: March 2009

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