Athersys and Angiotech announce authorization of Phase I intramyocardial stem cell U.S. clinical trial in acute myocardial infarction



    CLEVELAND, OH and VANCOUVER, Dec. 20 /CNW/ - Athersys, Inc. (Nasdaq:  
ATHX) and Angiotech Pharmaceuticals, Inc. (NASDAQ:   ANPI, 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:   ANPI, TSX: ANP),
please visit our website at 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
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"believes," "may," "could", "plans," "will," "estimate," "continue,"
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Litigation Reform Act of 1995 and constitute "forward-looking information"
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are made pursuant to the "safe harbor" provisions of applicable securities
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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..





For further information:

For further information: Angiotech Contacts: Jodi Regts, Senior Manager,
Investor Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-7930, jregts@angio.com; Deirdre Neary, Manager, Investor
Relations, Angiotech Pharmaceuticals, Inc., (604) 222-7056, dneary@angio.com;
Athersys, Inc. Contacts: William (B.J.) Lehmann, J.D., President and Chief
Operating Officer, Athersys, Inc., (216) 431-9900, bjlehmann@athersys.com;
Lisa M. Wilson, In-Site Communications, (917) 543-9932,
insiteco@ix.netcom.com

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