VANCOUVER, Sept. 23 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) ("Angiotech") and
partner Athersys, Inc. (NASDAQ: ATHX) announced updated results
from its phase I clinical trial of MultiStem(R), its allogeneic
cell therapy product, administered to individuals following acute
myocardial infarction (AMI), more commonly referred to as a heart
attack. The updated study results were presented at the
Transcatheter Cardiovascular Therapeutics (TCT) Conference held in
Washington, D.C. Dr. Marc Penn, M.D., Ph.D., co-principal
investigator of this study and Director of Cardiovascular Cell
Therapy at the Cleveland Clinic, and Director of the Skirball
Laboratory for Cardiovascular Cellular Therapeutics presented the
results at the Symposium "Strategies for Cardiovascular Repair:
Stem Cell Therapy and Beyond." The study results, based on four
months of post-treatment patient data, demonstrate that MultiStem
was well tolerated at all dose levels and also suggest improvement
in heart function in treated patients.
New data presented by Dr. Penn included additional information
about the nature and incidence of adverse events (AEs) over the
first four months of the trial, demonstrating that the AEs were
generally mild-to-moderate in nature, there was no dose dependent
effect of MultiStem on AEs, and overall, MultiStem had a favorable
safety profile. Further, Dr. Penn shared the results from
additional analysis of echocardiogram data collected over the first
four months of the study, which suggests that MultiStem
administration may also provide improvements in other measures of
heart function. Patients receiving MultiStem, for instance,
demonstrated a meaningful improvement in mean wall motion score at
four months compared to baseline, though this improvement was not
statistically significant. Interestingly, among those patients with
more severe heart attacks (i.e. left ventricular ejection fraction
(LVEF), a measure of heart function, (less than or equal to) 45),
the mean wall motion score for treated patients improved over the
four-month period, while for registry patients it worsened over
this time.
"We are continuing to see strong findings from this phase I
study that suggest that MultiStem is well tolerated and that
administration following a heart attack could provide a meaningful
improvement in functional heart measures," said Dr. Penn. "These
data are the first from a human trial that match the magnitude of
effect seen in the preclinical studies, and support further
evaluation of MultiStem as a safe and effective treatment following
heart attack."
The phase I clinical trial is an open label, multi-center dose
escalation trial evaluating the safety and maximum tolerated dose
of a single administration of allogeneic MultiStem cells following
an AMI. Enrolled patients received MultiStem delivered via a
catheter into the damaged region of the heart 2-5 days following
percutaneous coronary intervention, a standard treatment for heart
attack. The study includes patients in three treatment cohorts or
dose groups (20 million, 50 million and 100 million cells per
patient) and a registry group where patients received only standard
of care. Nineteen treated and six registry subjects participated in
the study. The trial is being conducted at cardiovascular treatment
centers in the United States,
including the Cleveland Clinic, Columbia
University Medical Center, Henry Ford Health System,
MetroHealth System, Cardiology PC, The Care Group, and Hamot
Medical Center.
In his presentation, Dr. Penn also highlighted initial findings
from the phase I clinical trial, which were announced by Athersys
in July. Based on four months of post-treatment patient data, the
findings showed that administration of MultiStem was well tolerated
at all dose levels and there were no clinically significant changes
in vital signs, allergic reactions or infusion-related toxicities.
Each of the trial's three dose groups demonstrated improvement in
mean LVEF when compared to baseline. Further, patients in the
MultiStem 50 million cell dose group showed a statistically
significant improvement in mean four-month LVEF relative to
baseline with a 23.4% improvement (p(less than)0.02). Additionally,
in those patients with more severe heart attacks and LVEFs less
than or equal to only 45%, the MultiStem 50 and 100 million cell
dose groups each demonstrated a greater than 25% improvement in
mean LVEF when compared to baseline.
"We believe the additional data from this phase I study further
supports the safety profile of MultiStem as potential treatment to
improve cardiac function after AMI," said William Hunter, M.D., President and CEO of
Angiotech. "We look forward to working with our partner, Athersys,
to further develop this exciting technology."
Athersys and Angiotech continue to evaluate the phase I results
with study investigators and have begun planning for a subsequent
clinical study, which they currently anticipate will be initiated
in 2011. Further guidance about subsequent clinical development,
such as trial design and timing, will be provided after evaluation
and planning are completed and discussion with the FDA has
occurred.
Forward Looking Statements
--------------------------
Statements contained in this press release that are not based on
historical fact, including without limitation statements containing
the words "believes," "may," "plans," "will," "estimates,"
"continues," "anticipates," "intends," "expects" and similar
expressions, constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995 and
constitute "forward-looking information" within the meaning of
applicable Canadian securities laws. All such statements are made
pursuant to the "safe harbor" provisions of applicable securities
legislation. Forward- looking statements may involve, but are not
limited to, comments with respect to our objectives and priorities
for the remainder of 2010 and beyond, our strategies or future
actions, our targets, expectations for our financial condition and
the results of, or outlook for, our operations, research and
development and product and drug development. Such forward-looking
statements involve known and unknown risks, uncertainties and other
factors that may cause the actual results, events or developments
to be materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Many such known risks, uncertainties and other factors
are taken into account as part of our assumptions underlying these
forward-looking statements and include, among others, the
following: general economic and business conditions in the United States, Canada and the other regions in which we
operate; market demand; technological changes that could impact our
existing products or our ability to develop and commercialize
future products; competition; existing governmental legislation and
regulations and changes in, or the failure to comply with,
governmental legislation and regulations; availability of financial
reimbursement coverage from governmental and third-party payers for
products and related treatments; adverse results or unexpected
delays in pre-clinical and clinical product development processes;
adverse findings related to the safety and/or efficacy of our
products or products sold by our partners; decisions, and the
timing of decisions, made by health regulatory agencies regarding
approval of our technology and products; the requirement for
substantial funding to conduct research and development, to expand
manufacturing and commercialization activities; and any other
factors that may affect our performance. In addition, our business
is subject to certain operating risks that may cause any results
expressed or implied by the forward-looking statements in this
press release to differ materially from our actual results. These
operating risks include: our ability to attract and retain
qualified personnel; our ability to successfully complete
pre-clinical and clinical development of our products; changes in
our business strategy or development plans; our failure to obtain
patent protection for discoveries; loss of patent protection
resulting from third-party challenges to our patents;
commercialization limitations imposed by patents owned or
controlled by third parties; our ability to obtain rights to
technology from licensors; liability for patent claims and other
claims asserted against us; our ability to obtain and enforce
timely patent and other intellectual property protection for our
technology and products; the ability to enter into, and to
maintain, corporate alliances relating to the development and
commercialization of our technology and products; market acceptance
of our technology and products; our ability to successfully
manufacture, market and sell our products; the availability of
capital to finance our activities; our ability to restructure and
to service our debt obligations; and any other factors referenced
in our other filings with the applicable Canadian securities
regulatory authorities or the Securities and Exchange Commission
("SEC"). For a more thorough discussion of the risks associated
with our business, see the "Risk Factors" section in our annual
report for the year ended December 31,
2009 filed with the SEC on Form 10-K, as amended, and our
quarterly report for the second quarter of 2010 filed with the SEC
on Form 10-Q.
Given these uncertainties, assumptions and risk factors,
investors are cautioned not to place undue reliance on such
forward-looking statements. Except as required by law, we disclaim
any obligation to update any such factors or to publicly announce
the result of any revisions to any of the forward-looking
statements contained in this press release to reflect future
results, events or developments.
(C)2010 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty
pharmaceutical and medical device company. Angiotech discovers,
develops and markets innovative treatment solutions for diseases or
complications associated with medical device implants, surgical
interventions and acute injury. To find out more about Angiotech
(NASDAQ: ANPI, TSX: ANP), please visit our website at
www.angiotech.com.
About Athersys
Athersys is a clinical stage biopharmaceutical company engaged
in the discovery and development of therapeutic product candidates
designed to extend and enhance the quality of human life. The
Company is developing MultiStem(R), a patented, adult-derived
"off-the-shelf" stem cell product platform for multiple disease
indications, including damage caused by myocardial infarction, bone
marrow transplantation and oncology treatment support, ischemic
stroke, and inflammatory bowel disease. The Company is also
developing a portfolio of other therapeutic programs, including
orally active pharmaceutical product candidates for the treatment
of metabolic and central nervous system disorders, utilizing
proprietary technologies, including Random Activation of Gene
Expression (RAGE(R)). Athersys has forged several key strategic
alliances and collaborations with leading pharmaceutical and
biotechnology companies, including Pfizer, Angiotech and
Bristol-Myers Squibb, as well as world-renowned research
institutions in the United States
and Europe to further develop its
platform and products.
SOURCE Angiotech Pharmaceuticals, Inc.
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