Interim Results From Aastrom's IMPACT-DCM Cardiac Trial Presented at The American Heart Association Meeting
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- Published on Monday, 16 November 2009 02:00
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National PI Presents Encouraging Progress in U.S. Cardiac Clinical Trial
ANN ARBOR, MI, USA | November 16, 2009 | Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of autologous cell products for the treatment of severe, chronic cardiovascular diseases, announced today that Amit N. Patel, M.D., M.S., Associate Professor of Surgery at the University of Utah School of Medicine and the National Principal Investigator of the Company's U.S. Phase II IMPACT-DCM clinical trial provided an oral presentation on Sunday evening at the American Heart Association (AHA) Scientific Sessions 2009. Dr. Patel presented encouraging interim data suggesting that the majority of patients treated to date with Cardiac Repair Cells (CRCs) have shown improvements in their heart failure classification, while patients in the control group, who did not receive CRCs, did not have a similarly improved outcome.
Dr. Patel presented New York Heart Association (NYHA) Functional Classification data from Aastrom's IMPACT-DCM trial for "treatment patients" (patients treated with CRCs) and "control patients". All of the patients included in this IMPACT-DCM interim subset were classified with NYHA Class III heart failure when they entered the trial. Interim findings presented by Dr. Patel are as follows:
* Of the 7 treatment patients who have completed the 1-month follow-up visit, 1 patient had improved to NYHA Class I and 3 patients had improved to Class II. In contrast, at the 1-month follow-up visit, the NYHA Class did not improve in 3 of the 5 control patients.
* Of the 6 treatment patients who have completed the 3-month follow-up visit, 1 patient improved to NYHA Class I and 2 patients improved to Class II. In contrast, at the 3-month follow-up visit, the NYHA Class did not improve in 4 of the 5 control patients.
* Of the 5 treatment patients who have completed the 6-month follow-up visit, 2 patients improved to NYHA Class I, 2 patients improved to Class II and 1 patient deteriorated to NYHA Class IV. In contrast, at the 6-month follow-up visit, the NYHA Class did not improve in 3 of the 5 control patients, including 1 patient who deteriorated to NYHA Class IV.
"The IMPACT-DCM patients continue to demonstrate encouraging early results," said Dr. Patel. "DCM is a devastating disease that generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Remarkably, in the IMPACT-DCM trial, we see improvements across the ischemic patients as well as the non-ischemic patients suffering from DCM."
"We are pleased with the early clinical data that are being reported in our Phase II cardiac regeneration study. We continue to see positive trends that indicate clinically meaningful improvement in these patients. We had enrolled 29 patients into the trial by November 6th and patient enrollment continues at a steady pace. Aastrom looks forward to analyzing and presenting interim data as the trial progresses, and once all 40 patients have completed their 6-month follow-up visit," said Elmar R. Burchardt, M.D., Ph.D., Vice President, Medical Affairs of Aastrom.
About New York Heart Association (NYHA) Functional Classification
The NYHA classification is a widely accepted and important clinical endpoint to describe the extent of heart failure and places patients in one of four categories based on how much they are limited during physical activity. The limitations and symptoms take into account normal breathing and varying degrees of shortness of breath and/or angina pain.
* Patients categorized in Class I typically have no symptoms and no limitation in ordinary physical activity (e.g. shortness of breath when walking, climbing stairs, etc.).
* Patients categorized in Class II typically have mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
* Patients categorized in Class III typically have marked limitation in activity due to symptoms, even during mild activity (e.g. walking short distances) and are comfortable only at rest.
* Patients categorized in Class IV (the most serious class) are typically bedbound, have severe limitations and experience symptoms even while at rest.
About Dilated Cardiomyopathy (DCM)
Many of the 5.5 million people in the U.S. suffering from severe heart failure have DCM, a condition where expansion of the patient's heart reduces pump function, making it impossible to maintain normal blood circulation. Patients with DCM typically have symptoms of congestive heart failure, including severe limitations in physical activity and shortness of breath. DCM generally occurs in patients who have ischemic heart failure due to multiple heart attacks, though it can also be found in patients with non-ischemic heart failure caused by hypertension, viral infection or alcoholism. Patient prognosis depends upon the stage of the disease but is typically characterized by numerous health problems and a very high mortality rate.
About Aastrom's U.S. Phase II IMPACT-DCM Clinical Trial
Aastrom's open-label Phase II study seeks to enroll 20 patients with ischemic DCM and 20 patients with non-ischemic DCM at five clinical sites in the U.S. Participants must have a left ventricular ejection fraction (LVEF) of less than or equal to 30% (60-75% is typical for a healthy person) and meet certain other eligibility criteria. The study protocol states that patients in each group will receive standard medical care and approximately 75% of patients will be treated with CRCs through direct injection into the heart muscle during minimally invasive open heart surgery. While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including LVEF, heart failure stage and other measures of cardiac function will be monitored. The Company intends to follow patients in the study for 12 months post treatment.
IMPACT-DCM is the first clinical trial in the U.S. to evaluate the surgical delivery of autologous cells directly into the human heart muscle for the treatment of congestive heart failure associated with DCM in both ischemic and non-ischemic patients. Patients randomized into the treatment group of the IMPACT-DCM trial are treated with Aastrom's CRCs, an autologous, mixed-cell product containing expanded populations of stem and early progenitor cells produced from a small sample of the patient's own bone marrow.
About Aastrom Biosciences, Inc.
Aastrom is a leader in regenerative medicine developing autologous cell products for the treatment of severe, chronic cardiovascular diseases. The Company's proprietary Tissue Repair Cell (TRC) technology expands the numbers of stem and early progenitor cells from a small amount of bone marrow collected from the patient. Bone marrow provides a rich source of diverse cell populations, is easily accessible and allows Aastrom to produce a personalized treatment for site-specific delivery to the patient's diseased tissues. Aastrom has treated more than 350 patients in various clinical trials over 10 years without any product safety issues. The Company is currently conducting a Phase II cardiac regeneration clinical trial (the IMPACT-DCM trial) in patients with dilated cardiomyopathy (DCM -- severe chronic heart failure) and a Phase IIb vascular regeneration clinical trial (the RESTORE-CLI trial) in patients with critical limb ischemia (CLI -- the most severe form of peripheral arterial disease). Aastrom has also recently announced that the Company will initiate its U.S. Phase II clinical trial to evaluate the catheter delivery of CRCs for the treatment of DCM.
SOURCE: Aastrom Biosciences, Inc.