First Heart Failure Patients Successfully Implanted with Angioblast Systems' "Off-the-Shelf" Adult Stem Cells
NEW YORK--(BUSINESS WIRE)--Oct 12, 2008 - Angioblast Systems Inc. today announced successful initial safety results following commencement of the world's first clinical trial to use allogeneic adult stem cells obtained from an unrelated, universal donor to treat patients with congestive heart failure.
The multi-center Phase 2 trial is examining the safety and effectiveness of three different doses of the company's proprietary allogeneic, "off-the-shelf," universal donor Mesenchymal Precursor Cells (MPCs) injected by catheter into damaged heart muscle of patients with congestive heart failure.
Safety data from the first seven patients enrolled in the trial by Angioblast at medical centers in Arizona, California, and Minnesota were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington D.C.
Dr. Nabil Dib, Director of Cardiovascular Research for Chandler Regional and Mercy Gilbert Medical Centers in Arizona, reported that no adverse events had occurred in any of the first seven patients following the catheter procedure.
The placebo-controlled trial of Angioblast's Revascor(TM) MPC cell therapy will randomize up to 60 patients suffering from congestive heart failure, including those with non-ischemic cardiomyopathy, to either implantation with allogeneic adult stem cells or standard of care in a 3:1 ratio.
Angioblast's Revascor(TM) adult stem cells are delivered to damaged areas of the heart by a minimally invasive cardiac catheterization procedure performed under local anesthesia while the patient is awake. Patients undergoing the procedure are released from the hospital within 24 hours.
Dr. Dib said: "We hope that the stem cells will increase the potential for myocardial repair and restoration of heart function. Angioblast's Revascor(TM) cells are a well characterized, pure population of MPCs. These cells, obtained from a healthy young adult donor, are isolated, expanded and cultured to produce treatments potentially for thousands of patients."
According to company founder, Professor Silviu Itescu, "Heart failure remains a major cause of hospital admissions and patient deaths. Based on studies to date, our Revascor(TM) MPCs have the potential to make a significant impact in patients with heart failure and to address this major clinical need.
"This Phase 2 clinical trial is an important step toward our entry into this vital and growing market," Professor Itescu said.
About Heart Failure
There are currently five million people in the United States living with heart failure, and trends indicate that the incidence of heart failure has not declined in the last 20 years. As the number of people living in the United States with cardiovascular disease continues to rise at a rate of 550,000 new cases annually, the health and economic burden of this disease will greatly impact the population's health status. It is estimated that the healthcare cost to care for heart failure patients is in excess of $29 billion per year.
Heart failure results from the progressive deterioration of the pumping function of the heart, leading to its inability to pump sufficient blood to the body's tissues, organs and limbs. The majority of heart failure patients have underlying cardiovascular disorders that are often the precursors of their condition. The most common of these are atherosclerosis, myocardial infarction, hypertension, cardiomyopathy and arrhythmia.
About Angioblast Systems, Inc.
Angioblast Systems, Inc. is a private New York City-based biotechnology company committed to the development of novel treatments for cardiac, vascular, and eye conditions. Angioblast's lead products are based on commercialization of a unique adult stem cell technology capable of regulating blood vessel growth critical for the treatment of ischemic heart disease and macular degeneration/diabetic eye disease. Angioblast's focus is to progress through clinical trials and regulatory processes necessary to commercialise the technology in as short a timeframe as possible. Angioblast has the worldwide assignment of rights for a series of patents and technologies that have been developed over more than 10 years and which relate to the identification, extraction, culture expansion and enablement of adult Mesenchymal Precursor Cells (MPCs).
Revascor(TM) is a trademark of Angioblast Systems Inc.
NOTE TO MEDIA: Broadcast quality, high-resolution b-roll footage and additional images are available upon request.
MacDougall Biomedical Communications
Cory Tromblee or Jennifer Greenleaf
Michael Schuster, MS, MBA, 212-880-2060
Vice President of Operations
Posted: October 2008