Aastrom to Initiate Phase II Clinical Trial Using Cardiac Repair
Cells Derived From Patient's Own Bone Marrow for Treatment of Severe
Chronic Heart Failure
FDA Authorizes IND Application for Aastrom's First Cardiac
Regeneration Clinical Trial
ANN ARBOR, Mich., June 17, 2008 (PRIME NEWSWIRE) -- Aastrom
Biosciences, Inc. (Nasdaq:ASTM)
company, today announced plans to initiate a 40 patient U.S. Phase II
clinical trial to study the use of Cardiac Repair Cells (CRCs), a
mixture of stem and progenitor cells derived from a patient's own
bone marrow, for the treatment of dilated cardiomyopathy (DCM), a
severe form of chronic heart failure. Aastrom is now authorized under
U.S. Food & Drug Administration (FDA) regulations to initiate its
first Investigational New Drug (IND) clinical trial for cardiac
regeneration. CRCs, manufactured using Aastrom's Tissue Repair Cell
(TRC) technology, previously received Orphan Drug Designation from
the FDA for the treatment of DCM.
"This landmark trial is the first in the world to target both
ischemic and non-ischemic DCM patients. It is also the first trial in
the U.S. to evaluate the surgical delivery of autologous cells
directly into the source of the problem, the heart muscle, for the
treatment of congestive heart failure due to DCM," stated David A.
Bull, M.D., Professor of Surgery and Chief of Cardiothoracic Surgery
at the University of Utah School of Medicine. "Aastrom's unique
technology is able to produce a mixed cell population that we believe
may be efficacious for treating these end-stage patients and is our
primary motivation for participating in the trial."
The randomized, controlled, prospective, open-label, Phase II study
will seek 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 of less than or equal
to 25% (60-75% is typical for a healthy person) and meet certain
other eligibility criteria. All patients in each group will receive
standard medical care and 75% of the patients will be treated with
CRCs through direct injection into the heart muscle during open heart
surgery. While the primary objective of this study is to assess the
safety of CRCs in patients with DCM, efficacy measures including left
ventricular ejection fraction and other cardiac function parameters
as well as heart failure stage will be monitored. Patients will be
followed for 12 months post treatment.
"Aastrom's trial is targeting critically ill patients with heart
failure. These patients, with enlarged, weakened hearts, are at the
end-stage of their disease and currently have no treatment options
other than a heart transplant," said Mariell Jessup M.D., Professor
of Medicine and Medical Director of Heart Failure and
Transplantation, at the University of Pennsylvania Health
System. "Without a new therapeutic approach the majority of these
patients will continue to decline and less than 40% will survive five
years."
There are currently 5.5 million people in the U.S. suffering from
chronic heart failure. A subset of these patients has DCM, a chronic
cardiac disease where expansion of the patient's heart reduces the
pump function to a point that the normal circulation of blood cannot
be maintained. Patients with DCM typically present with symptoms of
congestive heart failure, including severe limitations in their
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 on the stage of the disease but is
characterized by numerous health problems and a very high mortality
rate.
"After initial positive patient experience in the EU, we are pleased
to be advancing our promising CRC program into the clinic in the
U.S.," said George Dunbar, President and Chief Executive Officer of
Aastrom. "The IND approval for a Phase II trial to treat patients
suffering from DCM supports our decision to focus our efforts and
resources primarily on cardiac regeneration. As we move our cardiac
development program forward, we will stop enrolling patients in our
ON-CORE clinical trial for bone regeneration until we identify a
partner to work with us to complete that effort. Patients who have
already been treated in the ON-CORE trial will be followed by their
physicians for the full 24 month follow-up period. Our RESTORE-CLI
clinical trial targeting critical limb ischemia will continue as
planned."
About Orphan Drug Designation
The Orphan Drug Designation is granted to development-
such as Aastrom's CRCs, that offer potential therapeutic value in the
treatment of rare diseases and conditions. The Company may be
entitled to several benefits prior to approval, including an
expedited FDA review, the reduction or even elimination of filing
fees, and the availability of possible tax credits, and will be
entitled to seven years of marketing exclusivity once the product
receives FDA approval.
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 cardiovascular, bone
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 cardiovascular
regeneration product in Phase II development for the treatment of
dilated cardiomyopathy (DCM) (called the IMPACT-DCM trial) and
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), and a
preclinical research program targeting unmet needs in neural health.
Aastrom product candidates to treat DCM and osteonecrosis of the
femoral head have been designated for orphan drug status by the FDA.
For more information, visit Aastrom's website at www.aastrom.
(astmc)
The Aastrom Biosciences, Inc. logo is available at
http://www.primenew
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,
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.
CONTACT: Aastrom Biosciences, Inc.
Investor Relations Department
Kris M. Maly
(734) 930-5777
Berry & Company
Media
Stephen Zoegall
(212) 253-8881
Cameron & Associates
Investors
Kevin McGrath
(212) 245-4577
http://www.primenew
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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