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Encouraging Clinical Data Reported From Aastrom's First EU Compassionate Use Cardiac...
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Encouraging Clinical Data Reported From Aastrom's First EU Compassionate Use
Cardiac Patients
ANN ARBOR, Mich., April 17, 2008 (PRIME NEWSWIRE) -- Aastrom Biosciences, Inc.
(Nasdaq:ASTM), a leading regenerative medicine company, today announced
encouraging data from the first two compassionate use patients treated with the
Company's autologous stem cell therapy for dilated cardiomyopathy (DCM), a type
of severe chronic heart failure. Hans Michael Klein, M.D., Professor of Cardiac
Surgery at the Dusseldorf University Hospital in Dusseldorf, Germany performed
the first human application of Aastrom's Cardiac Repair Cell (CRC) product
through direct injection into the heart muscle during open heart surgery in two
patients late in 2007. Due to the promising results from these first patients
using the CRC treatment, Dr. Klein's clinical activity is ongoing and additional
patients are being evaluated for this treatment.
"I have had the opportunity to treat over 70 severe heart failure patients with
cell therapy during my career. Until now, the most severe patients had little
chance for long-term treatment success. CRCs have the potential to become the
new standard of care for patients suffering from DCM," said Dr. Klein. "These
patients have a very low quality of life and fewer than 40% survive five years.
The improvements we observe in their heart function allow us to measure their
progress. We have noted this parallels the substantial improvement in the
patient's symptoms and their heart failure stage. These first two cases have
been very positive, so I am eager to continue this clinical activity with
Aastrom's CRC product."
Dr. Klein's first patient, a 74 year old male diagnosed with ischemic dilated
cardiomyopathy who also suffered from extensive three-vessel coronary heart
disease, renal insufficiency and unstable angina pectoris (chest pain), was
treated with CRCs in November 2007. This patient met the clinical criteria for
the most advanced stage of heart failure (class IV) under the New York Heart
Association classification guidelines, with severe shortness of breath even
without physical activity and when lying in bed. Prior to the CRC treatment his
left ventricular ejection fraction was 10% (the percentage of blood pumped out
of the heart with each contraction), below the normal range of 60-75% for a
typical healthy person. After the CRC treatment and upon discharge from the
hospital in January 2008, this patient's ejection fraction had improved to
25-30% and clinical improvement of his heart failure stage had been noted.
The second patient, a 69 year old female diagnosed with severe DCM, also
suffered from extensive three-vessel coronary heart disease and had experienced
multiple previous heart attacks. This patient had previously undergone coronary
artery bypass grafting, several interventional treatments by catheter and had no
other treatment options when she was admitted to the hospital. Prior to the CRC
treatment her ejection fraction was 25-30%, and upon discharge from the hospital
in February 2008 her ejection fraction had improved to 45%.
"Our CRC product is distinguished from other cardiac cell therapies because it
is an autologous, mixed cell product that contains large doses of stem and
progenitor cells that may be ideal for patients with end-stage cardiac
diseases," said Elmar R. Burchardt, MD, PhD, Aastrom's Vice President, Medical
Affairs. "Dr. Klein's clinical experiences using our CRCs are extremely
important as we develop our U.S. clinical program. We will continue to target
the most severe patients suffering from DCM who, other than heart transplant,
have no treatment options."
Aastrom's proprietary CRCs received an Orphan Drug Designation from the U.S.
Food and Drug Administration (FDA) for use in the treatment of DCM in January
2007. In the U.S., Orphan Drug Designation provides a variety of incentives,
including seven years of market exclusivity following FDA approval.
Aastrom is on track for submission of a U.S. Investigational New Drug (IND)
application for a cardiac regeneration clinical trial using CRCs during 2008.
The Company's ultimate target market for CRCs in the U.S. is 1.8 million
no-option heart failure patients, which includes patients suffering from DCM.
About Aastrom Biosciences, Inc.
Aastrom is a leader in the development of autologous cell products for the
repair or regeneration of human tissue. The Company's proprietary Tissue Repair
Cell (TRC) technology involves the use of a patient's own cells to manufacture
products to treat a range of chronic diseases and serious injuries affecting
vascular, bone, cardiac and neural tissues. Aastrom's TRC-based products contain
increased numbers of stem and early progenitor cells, produced from a small
amount of bone marrow collected from the patient. The TRC technology platform
has positioned Aastrom to advance multiple products into clinical development.
Currently, the Company has a vascular regeneration product in clinical
development for the treatment of critical limb ischemia (called the RESTORE-CLI
trial), a bone regeneration product in Phase III development for the treatment
of osteonecrosis of the femoral head (called the ON-CORE trial), a cardiac
regeneration product in clinical development for dilated cardiomyopathy and a
preclinical research program targeting unmet needs in neural health. Aastrom
product candidates to treat osteonecrosis of the femoral head and dilated
cardiomyopathy have been designated for orphan drug status by the FDA. For more
information, visit Aastrom's website at www.aastrom.com. (astmc)
The Aastrom Biosciences, Inc. logo is available at
http://www.primenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including without limitation,
statements concerning clinical trial plans and expectations, clinical activity
timing, intended product development and commercialization objectives, adequacy
of existing capital to support operations for a specified time, future capital
needs, and potential advantages and application of Tissue Repair Cell (TRC)
Technology, all of which involve certain risks and uncertainties. These
statements are often, but are not always, made through the use of words or
phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we
believe," "we intend," and similar words or phrases, or future or conditional
verbs such as "will," "would," "should," "potential," "could," "may," or similar
expressions. Actual results may differ significantly from the expectations
contained in the forward-looking statements. Among the factors that may result
in differences are the inherent uncertainties associated with clinical trial and
product development activities, regulatory approval requirements, competitive
developments, and the availability of resources and the allocation of resources
among different potential uses. These and other significant factors are
discussed in greater detail in Aastrom's Annual Report on Form 10-K and other
filings with the Securities and Exchange Commission.
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CONTACT: Aastrom Biosciences, Inc.
Investor Relations Department
Kris M. Maly
(734) 930-5777
Cameron & Associates
(Investors)
Kevin McGrath
(212) 245-4577
Berry & Company
(Media)
Stephen Zoegall
(212) 253-8881
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