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Attention Business Editors
Angiotech Pharmaceuticals and partner Athersys announce positive results from phase I study of MultiStem(R) in heart attack patients
VANCOUVER, July 28 /CNW/ - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI,
TSX: ANP) ("Angiotech") and partner Athersys, Inc. (NASDAQ: ATHX) announced
positive 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
study results, which represent at least 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.
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 (PCI), 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 and
Henry Ford Health System.
Highlights of the Study:
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- Administration of MultiStem was found to be well tolerated at all
dose levels
- No clinically significant changes in vital signs, allergic reactions,
or infusion-related toxicities were associated with MultiStem
administration
- Each dose group showed improvement in mean left ventricular ejection
fraction (LVEF), a measure of heart function, compared to baseline
and relative to the registry group
- Patients in the 50 million dose group had a statistically significant
absolute improvement in mean 4-month LVEF relative to baseline (9.8
percentage points, representing a 23.4% improvement over baseline,
p less than 0.02)
- Among patients with more severe heart attacks - as measured by
baseline LVEFs less than or equal to 45% - the 50 and 100 million
dose groups each demonstrated better than a 25% improvement in mean
LVEF at 4 months post treatment over baseline
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"Myocardial infarction remains one of the leading causes of death and
disability in the United States," said William Hunter, M.D., President and CEO
of Angiotech. "We believe these positive Phase 1 results validate the value of
our partnership with Athersys, and we are looking forward to working with
Athersys to formulate the next clinical development steps for this important
product candidate."
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, plans to
present additional data and results and further discuss the study on September
22, 2010 in Washington, D.C. at the Symposium "Strategies for Cardiovascular
Repair: Stem Cell Therapy and Beyond," at the Transvascular Cardiovascular
Therapeutics Conference.
"These phase I results suggest that MultiStem is well tolerated when
administered to the damaged region of the heart following a heart attack,"
said Dr. Penn. "MultiStem's safety profile, together with trends suggesting
meaningful improvement in functional measures, illustrates the potential of
this therapy in this area and supports further clinical study of MultiStem for
the treatment of heart disease."
Safety
During the first 24 hours following MultiStem administration, patients
were assessed for infusion-related toxicity and other acute adverse events.
Subsequently, patients were evaluated for cardiac adverse events. The primary
endpoints for the study were the assessment of acute adverse events during the
first 24 hours following administration, post-acute adverse events up to 30
days, and catheter-related events.
The administration of MultiStem was found to be well tolerated at all
dose levels evaluated. There were no dose limiting toxicities associated with
the administration of MultiStem. Immediately following dosing, there were no
clinically significant changes to vital signs or evidence of allergic reaction
associated with MultiStem administration. Over the 30-day post-acute
observation period, no infusional toxicities or clinically significant cardiac
adverse events deemed to be definitely related to MultiStem occurred.
MultiStem had a favorable safety profile over the four-month period
following treatment. There was no dose dependent effect of MultiStem on
adverse events (AEs) and generally AEs were mild to moderate in nature.
Overall, there were several observed AEs characterized as potentially related
to MultiStem or catheter delivery. These were generally mild to moderate in
nature and were not dose dependent.
Heart Function
While the primary objective of this phase I study is to evaluate the
safety of MultiStem administered to AMI patients, echocardiogram data are
being collected and evaluated for evidence of efficacy signals to facilitate
planning for subsequent clinical studies, noting importantly that the study
was not powered for efficacy endpoints. Specifically, following a heart
attack, patients were screened by left ventriculogram and/or echocardiogram,
analyzed at the clinical site, to determine if their LVEFs met inclusion
criteria (30 to 45). Prior to MultiStem administration (and between 2-5 days
following PCI for registry patients), an additional echocardiogram was
performed, which served as the baseline for subsequent analysis. Additional
echocardiogram data were collected at prescribed time points according to the
protocol. Echocardiogram data collected for each patient were blinded, and
evaluated at a central facility.
The preliminary echocardiogram data demonstrated that each group had
improvement in mean LVEF at four months compared to mean baseline LVEF.
Patients receiving 20, 50, or 100 million MultiStem cells demonstrated
absolute improvements in mean LVEF at 4 months of 5.2, 9.8 and 1.5 percentage
points, respectively, compared to an absolute improvement of 1.1 percentage
points in the registry group. Although the study was not powered for efficacy
endpoints, patients in the medium dose group exhibited a statistically
significant improvement in LVEF over mean baseline for that group, 9.8
percentage points (p less than 0.02), representing a 23.4% improvement over
baseline. The improvement in mean LVEF for each group compared to the registry
group, though meaningful, was not statistically significant.
Notably, several patients in the high dose group exhibited substantially
higher baseline LVEFs than their initial screening LVEFs, which created a
higher baseline mean for that patient group. Including only patients whose
baseline LVEFs are less than or equal to 45, the absolute improvements in mean
LVEF were 3.9, 13.5 and 10.9 percentage points for the 20, 50, or 100 million
dose groups, respectively, compared to an absolute improvement of 0.9
percentage points in the registry group. Among these patients (i.e., LVEFs
less than or equal to 45), those in both the medium and high dose groups
exhibited a substantial increases in LVEF, representing more than 25%
improvements relative to baseline LVEF for those patient groups. Additional
analysis of the echocardiogram data is ongoing, and we will evaluate possible
effects on other measures of heart function.
"These preliminary phase I MultiStem results are consistent with the
results obtained in preclinical studies and compare favorably to the results
from other cell therapy treatments for AMI. This suggests that MultiStem could
have a meaningful impact on improving heart function following heart attack,"
stated Dr. Warren Sherman, co-principal investigator and Director of Stem Cell
Research and Regenerative Medicine, Center for Interventional Vascular Therapy
at Columbia University Medical Center in New York.
Further Evaluation and Development
Athersys and Angiotech will continue to evaluate the phase I results and
intend to begin 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.
Conference Call
Athersys, Inc. will host a conference call today at 4:30 PM (Eastern
Time) to review the top-line data results of the phase I clinical trial of
MultiStem, its cell therapy treatment for individuals following AMI (or heart
attack).
Investors and other interested parties are invited to listen to the
conference call by dialing 800-273-1254 in the U.S. and Canada, 973-638-3440
from abroad, or via a live Internet broadcast on Athersys' website at
www.athersys.com, under the Investor Relations section.
A replay will be available for on-demand listening shortly after the
completion of the call until 11:59 PM (Eastern Time) on August 11, 2010, at
the aforementioned URL, or by dialing 800-642-1687 in the U.S. and Canada, or
706-645-9291 from abroad, and entering access code 90560271.
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Forward Looking Statements
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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 first 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.
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/For further information: Rick Smith, Investor Relations and Corporate
Communications, Angiotech Pharmaceuticals, Inc., (604) 221-6933, ir@angio.com/
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