Athersys, Inc. (NASDAQ:ATHX and Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPI (NASDAQ:TSX: ANP ANP>), have announced 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 (NASDAQ:TSX:
(NASDAQ:ANP), visit http://www.angiotech.com or call 604/221-7930.
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.
For mor information, call 216/431-9900 or visit
http://www.athersys.com.
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