What is Stem Cell: [StemCells] Phase II MSC COPD

Osiris Therapeutics Initiates Phase II Clinical Trial Evaluating
Prochymal(TM) for Chronic Obstructive Pulmonary Disease
?? First-in-Class Stem Cell Therapy Now Being Evaluated to Treat
Fourth Leading Cause of Death
By BusinessWire
COLUMBIA, Md., BUSINESS WIRE -- Osiris Therapeutics, Inc.
(NASDAQ:OSIR) today announced the treatment of the first patients in
a new Phase II clinical trial evaluating Prochymal, a mesenchymal
stem cell (MSC) therapy, for moderate to severe Chronic Obstructive
Pulmonary Disease (COPD). This trial marks the sixth indication for
which Prochymal has been advanced into Phase II or later-stage
clinical trials.

COPD, a form of lung disease characterized by limitation or
obstruction of airflow in the airway, encompasses both emphysema and
chronic bronchitis. COPD is the fourth leading cause of death in the
U.S. with an estimated 12 million Americans diagnosed with the
disease. COPD has no known cure, thus current therapeutic
intervention is aimed at providing relief of symptoms. Preclinical
and clinical data suggest that Prochymal's unique mechanism of action
may provide a first-in-class treatment option with the ability to
reverse the underlying disease.

"Our COPD program serves as another example of how quickly and
efficiently we can now work towards developing this first-in-class
stem cell therapy," said C. Randal Mills, Ph.D., President and Chief
Executive Officer of Osiris Therapeutics. "With the early testing
completed, the clinical development and regulatory pathways are
significantly streamlined for future indications. This supports our
strategy to seek initial approval for the world's first stem cell
drug in relatively small underserved diseases, such as GvHD and
resistant Crohn's disease, and promptly expand the technology to
include blockbuster markets for which the technology also holds great
promise."

"Studies that we and others have conducted provide convincing
evidence that MSCs have the potential to be effective in addressing
selected lung diseases, including COPD," said Daniel Weiss, M.D.,
Ph.D., Associate Professor of Medicine at the University of Vermont
College of Medicine and an expert in research using stem cells to
treat lung diseases. "These mesenchymal stem cells are particularly
suited for treating pulmonary disease due to their inherent
trafficking pathway through the lungs when delivered intravenously
and their ability to remain in the lungs when inflammatory molecules
are present. With their demonstrated ability to both reduce
inflammation and reverse tissue damage, we have reason for optimism
about Prochymal's use in this devastating disease."

A recent Osiris study evaluating Prochymal as a treatment for
myocardial infarction demonstrated a statistically significant
improvement in lung function as compared to placebo. Specifically,
patients treated with Prochymal showed a 17 point improvement in FEV
(1) % predicted, a measure of pulmonary function, versus only a 6
point improvement in patients treated with placebo (p less than
0.05). Prochymal has also demonstrated clinical benefit in trials
evaluating patients with inflammatory conditions including graft-
versus-host disease (GvHD) and Crohn's disease, both of which are in
Phase III programs and have Food and Drug Administration (FDA) Fast
Track status.

"This landmark study is very exciting for the entire field and we are
honored to have been able to enroll and treat the first patients,"
said Charles Fogarty, M.D., Medical Director of Spartanburg Medical
Research. "We look forward to the results of this trial, which may
have long-term implications for improvements in disease progression
and remodeling of the lung."

About the Phase II Chronic Obstructive Pulmonary Disease Trial

The Phase II trial will evaluate the safety and efficacy of Prochymal
in conjunction with standard of care for improving pulmonary function
in patients with moderate to severe COPD. The clinical trial is a
double-blind, placebo-controlled study conducted at multiple sites
with a target enrollment of 60 patients. Patients will be randomized
to either Prochymal or placebo at a 1:1 ratio. Pulmonary function
tests, exercise capability, and quality of life are some of the
measurements being used to detect potential improvements in subjects
treated with Prochymal. In addition, exacerbations and
hospitalizations due to COPD will be monitored for both safety and
efficacy. Patients will be evaluated over the course of two years
following initial Prochymal or placebo infusion.

About Prochymal

Prochymal is a preparation of mesenchymal stem cells specially
formulated for intravenous infusion. The stem cells are obtained from
the bone marrow of healthy adult donors. Prochymal is currently being
evaluated in three, double-blind, placebo controlled Phase III
studies, including steroid refractory GvHD, acute GvHD, and Crohn's
disease. Prochymal has been granted Fast Track status by FDA for all
three of these indications. Prochymal also obtained Orphan Drug
status by FDA and the European Medicines Agency for GvHD. FDA
established the Fast Track program to accelerate the development of
drugs that show promise for treating life-threatening conditions.
Orphan Drug designation provides incentives to companies that develop
drugs for underserved patient populations. Prochymal is also being
studied in Phase II trials for the treatment of acute myocardial
infarction, type 1 diabetes, and COPD. Additionally, the Department
of Defense recently awarded Osiris a $224.7 million contract to
develop Prochymal for acute radiation syndrome.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is a leading stem cell therapeutic company
focused on developing and marketing products to treat medical
conditions in the inflammatory, orthopedic and cardiovascular areas.
Osiris currently markets and sells Osteocel(R) for regenerating bone
in orthopedic indications. Prochymal(TM) is being evaluated in Phase
III clinical trials for three indications, including acute and
steroid refractory Graft versus Host Disease and also Crohn's
disease, and is the only stem cell therapeutic currently designated
by FDA as both an Orphan Drug and Fast Track product. Osiris also has
partnered with Genzyme Corporation to develop Prochymal(TM) as a
medical countermeasure to nuclear terrorism and other radiological
emergencies. Prochymal is also being developed for the repair of
heart tissue following a heart attack, the protection of pancreatic
islet cells in patients with type 1 diabetes, and the repair of lung
tissue in patients with chronic obstructive pulmonary disease. The
Company's pipeline of internally developed biologic drug candidates
under evaluation also includes Chondrogen(TM) for arthritis in the
knee. Osiris is a fully integrated company, having developed
capabilities in research, development, manufacturing, marketing and
distribution of stem cell products. Osiris has developed an extensive
intellectual property portfolio to protect the company's technology
in the United States and a number of foreign countries including 47
U.S. and 253 foreign patents owned or licensed. More information can
be found on the company's website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

This press release contains forward-looking statements. Forward-
looking statements include statements about our expectations,
beliefs, plans, objectives, intentions, assumptions and other
statements that are not historical facts. Words or phrases such
as "anticipate," "believe," "continue," "ongoing," "estimate," "expect
," "intend," "may," "plan," "potential," "predict," "project" or
similar words or phrases, or the negatives of those words or phrases,
may identify forward-looking statements, but the absence of these
words does not necessarily mean that a statement is not forward-
looking. Examples of forward-looking statements include, but are not
limited to, statements regarding the following: our product
development efforts; our clinical trials and anticipated regulatory
requirements; the success of our product candidates in development;
status of the regulatory process for our biologic drug candidates;
implementation of our corporate strategy; our financial performance;
our product research and development activities and projected
expenditures, including our anticipated timeline and clinical
strategy for MSCs and biologic drug candidates; our cash needs;
patents and proprietary rights; ability of our potential products to
treat disease; our plans for sales and marketing; our plans regarding
our facilities; types of regulatory frameworks we expect will be
applicable to our potential products; and results of our scientific
research. Forward-looking statements are subject to known and unknown
risks and uncertainties and are based on potentially inaccurate
assumptions that could cause actual results to differ materially from
those expected or implied by the forward-looking statements. Our
actual results could differ materially from those anticipated in
forward-looking statements for many reasons, including the factors
described in the section entitled "Risk Factors" in our Annual Report
on Form 10-K filed with the United States Securities and Exchange
Commission. Accordingly, you should not unduly rely on these forward-
looking statements. We undertake no obligation to publicly revise any
forward-looking statement to reflect circumstances or events after
the date of this press release or to reflect the occurrence of
unanticipated events.

Contacts:
Osiris Therapeutics,
Inc. Erica Elchin,
443-545-1834 or Media: Schwartz Communications Stacey Holifield or
Andrew Law,
781-684-0770 Osiris@schwartz-pr.com

Copyright Business Wire 2008. All Rights Reserved

http://dmnnewswire.digitalmedianet.com/articles/viewarticle.jsp?
id=399114

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