Aastrom Announces Positive 12-Month Safety and Efficacy Data From IMPACT-DCM Phase 2 Clinical Trial for Ixmyelocel-T in Treat...
September 19 2011 - 8:00AM
Results presented today at 15th Annual Heart
Failure Society of America Scientific Meeting
Aastrom also announces results of six-month
interim analysis of DCM patients treated with ixmyelocel-T via
catheter administration.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of
patient-specific, expanded multicellular therapies for the
treatment of severe, chronic cardiovascular diseases, today
announced that 12-month follow up data from the IMPACT-DCM clinical
trial for ixmyelocel-T showed that treatment was well-tolerated and
that efficacy observations were consistent with improved function
of impaired myocardium in patients with dilated cardiomyopathy
(DCM) including ischemic cardiomyopathy (ICM) and idiopathic
dilated cardiomyopathy (IDC). Results were reported today by Amit
N. Patel, MD, MS, associate professor of surgery at the University
of Utah School of Medicine and national principal investigator for
Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial, in a poster
presentation at the 15th Annual Heart Failure Society of America
Scientific Meeting in Boston.
In the study, 40 patients diagnosed with ICM or IDC were
randomized 3 to 1 to either a single administration of ixmyelocel-T
or standard of care and were followed for 12 months. In the
ixmyelocel-T treatment group, bone marrow cells were cultured using
Aastrom's proprietary technology to expand the number of
mesenchymal cells, monocytes and macrophages while retaining many
of the mononuclear cells. This combination has been associated with
biological activity that promotes tissue remodeling,
immunomodulation, and promotion of angiogenesis.
Twenty-one of the 25 (84%) ixmyelocel-T patients completed the
12-month visit. Seven of 15 (47%) of the control patients completed
the 12-month visit, while an additional 5 of 15 (33%) of the
control patients enrolled into the extension phase of the study and
received ixmyelocel-T treatment. Results showed no difference in
adverse events in treatment and control group patients after the
initial post-operative period. ICM patients treated with
ixmyelocel-T showed improved outcomes compared to control. Efficacy
observations related to structural and functional end points
including major adverse cardiovascular events (MACE), New York
Heart Association (NYHA) functional classification, 6-minute walk
distance, and septal wall thickening, were consistent with improved
function of impaired myocardium.
"This study provides proof of principle that ixmyelocel-T can be
delivered to the impaired myocardium despite the serious disease
these patients have," said Dr. Patel, adding, "Cellular therapy
could represent a viable treatment option for DCM patients who
currently have no good options available."
Dr. Patel will present the poster, entitled: "Safety and
Efficacy of Ixmyelocel-T, an Expanded Patient-Specific Mixed Cell
Product, in Dilated Cardiomyopathy (IMPACT-DCM)," beginning at 5:45
P.M today. The poster will be on display from 9:30 A.M. to 7:00
P.M. (EDT).
In addition to the 12-month data from the IMPACT-DCM trial
involving surgical administration of ixmyelocel-T, Aastrom also
today announced positive results from a six-month interim analysis
of DCM patients treated with ixmyelocel-T via catheter
administration. In this analysis, functional improvements in
efficacy parameters were consistent with those seen in the
IMPACT-DCM trial results. In addition, the adverse event profile
suggests that catheter administration of ixmyelocel-T is safe and
appears to cause fewer adverse events compared to surgical
administration of ixmyelocel-T.
"The positive results from our 12-month analysis and evidence of
positive trends in our six-month analysis of patients with DCM are
encouraging and support our plans to complete clinical development
and pursue regulatory review of ixmyelocel-T for the treatment of
severe chronic cardiovascular conditions," said Tim Mayleben,
president and CEO of Aastrom. "Aastrom is currently conducting
Phase 2 trials of ixmyelocel-T in patients with DCM and preparing
to launch a pivotal Phase 3 clinical trial in the treatment of
critical limb ischemia."
About Aastrom Biosciences
Aastrom Biosciences is developing patient-specific, expanded
multicellular therapies for use in the treatment of severe, chronic
cardiovascular diseases. The company's proprietary cell-processing
technology enables the manufacture of ixmyelocel-T, a
patient-specific multicellular therapy expanded from a patient's
own bone marrow and delivered directly to damaged tissues. Aastrom
has advanced ixmyelocel-T into late-stage clinical development,
including a planned Phase 3 clinical program to study patients with
critical limb ischemia and two Phase 2 clinical trials in patients
with dilated cardiomyopathy. For more information, please visit
Aastrom's website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
This document contains forward-looking statements, including,
without limitation, statements concerning clinical trial plans and
progress, objectives and expectations, clinical activity timing,
intended product development, the performance and contribution of
certain individuals and expected timing of collecting and analyzing
treatment data, 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 or Transition Report on Form 10-K or
10-K/T, Quarterly Reports on Form 10-Q and other filings with the
Securities and Exchange Commission. These forward-looking
statements reflect management's current views and Aastrom does not
undertake to update any of these forward-looking statements to
reflect a change in its views or events or circumstances that occur
after the date of this release except as required by law.
CONTACT: Media contact
Bill Berry
Berry & Company
bberry@berrypr.com
(212) 253-8881
Investor contact
Danielle Spangler
The Trout Group
dspangler@troutgroup.com
(646) 378-2924
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