Athersys and Angiotech announce authorization of Phase I intramyocardial stem cell U.S. clinical trial in acute myocardial infar
20 Dezember 2007 - 1:00PM
PR Newswire (US)
CLEVELAND, OH and VANCOUVER, Dec. 20 /PRNewswire-FirstCall/ --
Athersys, Inc. (NASDAQ:ATHX) and Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX: ANP), announced today that Athersys has
received authorization from the U.S. Food and Drug Administration
(FDA) to begin a Phase I clinical trial evaluating the safety of
MultiStem(R) in the treatment of acute myocardial infarction (AMI).
The companies believe that this represents the first clinical study
of a scalable, allogeneic cell product injected directly into and
around the zone of myocardial injury from an intra-coronary
approach. This approach is designed to provide the clinician with a
readily usable, "off-the-shelf" cell therapy that combines the
benefits of efficient, localized delivery and enhanced cell
retention in the area of greatest need. 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. "Stem cell therapy offers
the promise of restoring the functionality of damaged heart tissue,
helping patients return to a more normal lifestyle following
serious heart attacks. We believe that the MultiStem(R) technology
has demonstrated significant promise in the preclinical setting and
has the potential to be an effective "off-the-shelf" cell therapy
product for the interventional cardiologist," commented Dr. Jeff
Walker, Senior VP, Research and Development for Angiotech.
"Building on the success of TAXUS(R) in revolutionizing stenting,
we are committed to and excited about the co-development of
MultiStem(R)," commented Dr. William Hunter, President and CEO of
Angiotech. "2008 brings a wealth of opportunity for Angiotech, with
the potential regulatory approvals of our 5-FU CVC in the U.S. and
our Vascular Wrap(TM) product in Europe, and with MultiStem(R), the
next generation of therapeutics in interventional cardiology,
entering the clinic." The Phase I study will be an open label,
multi-center dose escalation trial evaluating the safety and
maximum tolerated dose of single dose administration of allogeneic
MultiStem(R) following an AMI. Following standard treatment,
enrolled patients will receive MultiStem(R) delivered via a
microinfusion catheter, and these patients will be evaluated and
compared to patients receiving standard-of-care only. Athersys and
Angiotech have both evaluated the safety profile of MultiStem(R),
as well as this product candidate's potential to improve heart
function in multiple animal models, including well-validated
preclinical models of AMI. Based on the Athersys preclinical work,
the companies believe that MultiStem(R) can be administered safely
and that it may provide substantial functional benefit to patients
suffering severe heart attacks. About MultiStem(R) MultiStem cells
are proprietary adult stem cells derived from bone marrow, which
have the demonstrated ability to form a wide range of cell types.
MultiStem may work through several mechanisms, but a primary
mechanism appears to be the production of multiple therapeutic
molecules produced in response to inflammation and tissue damage.
Athersys believes that MultiStem represents a unique
"off-the-shelf" stem cell product based on its apparent ability to
be used without tissue matching or immunosuppression and its
capacity for large scale production. Based on research conducted by
Athersys and its manufacturing partner, Lonza, the company believes
that material from a single qualified donor may be used to produce
hundreds of thousands or even millions of clinical doses. About
Angiotech Angiotech Pharmaceuticals, Inc. is a global specialty
pharmaceutical and medical device company with over 1,500 dedicated
employees. 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:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. About Athersys, Inc. Athersys is a
biopharmaceutical company engaged in the discovery and development
of therapeutic product candidates designed to extend and enhance
the quality of human life. The company's lead product candidate,
ATHX-105, is an oral, selective 5HT2c receptor agonist in Phase I
clinical trials for the treatment of obesity. The company is
developing other 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). Athersys 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/oncology support, ischemic stroke and other
indications. 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," "could", "plans," "will," "estimate," "continue,"
"anticipates," "intends," "expects" and similar expressions,
constitute "forward-looking statements" within the meaning of the
U.S. 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 2007 and beyond, our strategies or future actions, our targets,
our estimation of potential market size, expectations for our
financial condition and the results of, or outlook for, our
operations, research development and further product and drug
development. Such forward-looking statements also 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. Such 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, both
nationally and in the regions in which we operate; technological
changes that impact our existing products or our ability to develop
and commercialize future products; competition; changes in business
strategy or development plans; the ability to attract and retain
qualified personnel; existing governmental regulations and changes
in, or the failure to comply with, governmental regulations;
adverse results or unexpected delays in drug discovery and clinical
development processes; 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; dependence upon, and
relationships with strategic alliance partners to develop and
commercialize products and services based on our work; our ability
to obtain rights to technology from licensors; liability for patent
claims and other claims asserted against us; the requirement for
substantial funding to conduct research and development and to
expand commercialization activities or consummate acquisitions; the
size of the market and the potential market for our products in
specific disease areas, other factors referenced in our annual
information form and other filings with the applicable Canadian
securities regulatory authorities or the Securities and Exchange
Commission; and any other factors that may affect performance. In
addition, our business is subject to certain operating risks that
may cause the actual results expressed or implied by the
forward-looking statements in this report to differ materially from
our actual results. These operating risks include: our ability to
successfully complete preclinical and clinical development of our
products; the ability to obtain and enforce timely patent and other
intellectual property protection for our technology and products;
decisions, and the timing of decisions, made by health regulatory
agencies regarding approval of our technology and products; the
ability to complete and maintain corporate alliances relating to
the development and commercialization of our technology and
products; market acceptance of our technology and products; the
competitive environment and impact of technological change; the
continued availability of capital to finance our activities; our
ability to integrate into our business the operations of AMI; and,
our ability to achieve the operational and other synergies and the
other commercial or financial benefits expected as a result of the
acquisition of AMI. Given these uncertainties, assumptions and risk
factors, readers are cautioned not to place undue reliance on such
forward-looking statements. 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 report to reflect future results, events or developments.
TAXUS(R) is a registered trademark of Boston Scientific
Corporation. Vascular Wrap(TM) is a trademark of Angiotech
Pharmaceuticals, Inc. MultiStem(R) is a registered trademark of
Athersys, Inc.. CONTACT: Angiotech Contacts: Jodi Regts, Senior
Manager, Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-7930, ; Deirdre Neary, Manager,
Investor Relations, Angiotech Pharmaceuticals, Inc., (604)
222-7056, ; Athersys, Inc. Contacts: William (B.J.) Lehmann, J.D.,
President and Chief Operating Officer, Athersys, Inc., (216)
431-9900, ; Lisa M. Wilson, In-Site Communications, (917) 543-9932,
DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: Angiotech
Contacts: Jodi Regts, Senior Manager, Investor Relations and
Corporate Communications, Angiotech Pharmaceuticals, Inc., (604)
221-7930, ; Deirdre Neary, Manager, Investor Relations, Angiotech
Pharmaceuticals, Inc., (604) 222-7056, ; Athersys, Inc. Contacts:
William (B.J.) Lehmann, J.D., President and Chief Operating
Officer, Athersys, Inc., (216) 431-9900, ; Lisa M. Wilson, In-Site
Communications, (917) 543-9932,
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