Angiotech Pharmaceuticals and partner Athersys announces completion of patient enrollment in phase I study of Multistem(R) in ac
17 Februar 2010 - 3:00PM
PR Newswire (US)
VANCOUVER, Feb. 17 /PRNewswire-FirstCall/ -- Athersys, Inc. and
Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP) announced
that Athersys has completed patient enrollment for its phase I
clinical trial of MultiStem(R), its allogeneic stem cell therapy
product, administered to individuals following acute myocardial
infarction (AMI), more commonly referred to as a heart attack. Top
line results of the trial are expected to be announced midyear,
upon completion of the four-month patient follow-up visits and
analysis of results. Angiotech and Athersys entered into an
agreement in May 2006 to co-develop and commercialize MultiStem(R),
Athersys' non-embryonic stem cell platform technology, for use in
the indications of AMI and peripheral vascular disease. Upon
completion of the Phase I trial, Angiotech will assume lead
responsibility for further clinical development. Angiotech also
owns marketing and commercial rights with respect to this product
candidate. "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 the data reported
to date and the completion of Phase I enrollment in this program
affirms 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."
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. Following standard treatment, enrolled patients receive
MultiStem delivered via a catheter that enables rapid and efficient
delivery of MultiStem into the damaged region of the heart. The
study is being conducted at multiple cardiovascular treatment
centers in the United States, including the Cleveland Clinic,
Columbia University Medical Center and Henry Ford Health System,
and includes patients in three treatment cohorts or dose groups, as
well as a non-treated registry group. In preclinical studies
conducted by Athersys and independent cardiovascular research
teams, administration of MultiStem following an ischemic injury to
the heart has been associated with a number of benefits, including
an increase in ejection fraction, or volume of blood pumped from
the heart, a reduction of inflammation in the region of ischemic
injury and increased angiogenesis, each believed to help augment
recovery and healing. Forward Looking Statements
-------------------------- Statements contained in this press
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"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 2009 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 regulations and
changes in, or the failure to comply with, governmental
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, 2008 filed with the SEC on
Form 10-K, as amended, and our quarterly reports for the first,
second and third quarters of 2009 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 , please visit our
website at http://www.angiotech.com/. About MultiStem(R) MultiStem
is a patented and proprietary cell therapy product consisting of a
special class of stem cells that are obtained from the bone marrow
or other tissue sources of healthy, consenting adult donors, and
which have the demonstrated ability to produce a range of factors,
as well as form multiple cell types. MultiStem appears to promote
tissue repair and healing in multiple ways, such as through the
production of multiple therapeutic factors produced in response to
signals of inflammation and tissue damage. Athersys believes that
MultiStem represents a unique "off-the-shelf" stem cell product
based on work that demonstrates the ability to deliver multiple
mechanisms of therapeutic benefit, administration of the product
without tissue matching or immunosuppression, and its capacity for
large-scale production. Athersys has forged strategic partnerships
with Pfizer to develop MultiStem for inflammatory bowel disease
(IBD) and with Angiotech to develop MultiStem in AMI and other
cardiovascular indications. In 2008, Athersys received the Frost
& Sullivan North American Product Innovation of the Year Award
for MultiStem, which cited the product as having best-in-class
potential among stem cell and regenerative medicine technologies.
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, as well as
world-renowned research institutions in the United States and
Europe to further develop its platform and products. DATASOURCE:
Angiotech Pharmaceuticals, Inc. CONTACT: Sharrifah Al-Salem,
Investor Relations and CorporateCommunications, Angiotech
Pharmaceuticals, Inc., (415) 293-4414,Sharrifah.Al-Salem@FD.com
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