Source: BUSINESS WIRE
Thursday, June 25, 2009
COLUMBIA, Md.--(BUSINESS WIRE)--Osiris Therapeutics, Inc. (NASDAQ:OSIR) today announced six-month
interim data from a Phase II clinical trial evaluating Prochymal, the
Company’s proprietary formulation of adult mesenchymal stem cells, for
the treatment of chronic obstructive pulmonary disease (COPD). Sixty-two
patients were enrolled and are being followed for two years in the
placebo-controlled study. At the six-month time-point, the data revealed
several important findings.
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Important Findings:
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The trial met its primary goal of demonstrating the safety of
Prochymal in patients with compromised pulmonary function at the
six-month evaluation point.
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Prochymal significantly decreased systemic inflammation in patients
when compared to those receiving placebo, as determined by C-reactive
protein (CRP).
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Despite the reduction in inflammation, pulmonary function in patients
receiving Prochymal was not significantly improved compared to those
receiving placebo.
“We are very pleased with the interim outcome of this study and that the
data continues to support the strong safety profile of this therapy,
particularly given the severity of these patients’ pulmonary disease,”
said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics.
“Importantly, we are gratified to obtain clear, objective data that
helps bolster our understanding of the anti-inflammatory effects of
these remarkable cells. Short-term, these anti-inflammatory effects did
not appear to improve pulmonary function in patients with advanced
destructive changes of the lung. Collectively however, these findings
add to our confidence about the safety and effectiveness of the drug.”
Six-Month Interim Data
Prochymal was evaluated in a total of 62 patients, 58% of them male. The
patients ranged in age from 47 to 80 years and suffered from moderate
(n=23) to severe (n=39) COPD. Patients had been suffering with COPD for
an average of 7.8 years. Patients with asthma were excluded from the
trial.
All patients in the trial completed the planned course of four infusions
without any evidence of infusional toxicity. Oxygen saturation levels
were measured throughout each infusion and showed no adverse effects of
the infusion. Adverse event rates were comparable for patients receiving
Prochymal and placebo. There were no signs of adverse immune reaction
after any of the four infusions and no differences in the reported
incidence of infection of any kind.
Prochymal significantly decreased the levels of CRP compared to placebo
in those patients with elevated CRP (>4 mg/L) at the time of study entry
(p<0.05). The difference from placebo was evident at ten days post
initial infusion, and was maintained throughout the treatment and
follow-up period. CRP is a protein found in the blood in response to
inflammation and is often elevated in inflammatory diseases such as GvHD
and Crohn’s disease, and has been found to correlate with clinical
parameters of disease activity. Although there is substantial
preclinical evidence, this study provides the first well-controlled
objective data confirming the systemic anti-inflammatory effects of
Prochymal in humans.
Pulmonary function tests such as FEV1 and DLCO or carbon monoxide
diffusing capacity of the lung were not improved over placebo following
treatment with Prochymal at six months. FEV1 or forced expiratory volume
is the amount of air that can forcibly be blown out of the lungs in the
first second of exhalation. Although not reaching statistical
significance, treatment with Prochymal did produce positive trends in
exploratory functional endpoints such as the six-minute walk test and
certain cardiac related parameters, particularly in patients with less
established COPD.
The trial will continue as planned and patients will be followed for the
balance of the two-year evaluation period.
About the Phase II Chronic Obstructive Pulmonary Disease Trial
The Phase II trial is evaluating the safety of Prochymal in conjunction
with standard of care in patients with moderate to severe COPD. The
clinical trial is a double-blind, placebo-controlled study. A total of
62 patients were randomized to either Prochymal or placebo at a 1:1
ratio. In order to explore potential improvements in pulmonary function,
several evaluations including pulmonary function tests, exercise
capability, and quality of life assessments are being conducted. 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, avoiding the controversy
surrounding embryonic and fetal cell sources. 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. Prochymal is also
being studied in Phase II trials for the treatment of acute myocardial
infarction and type 1 diabetes. Additionally, the Department of Defense
awarded Osiris a contract to develop Prochymal as a treatment for acute
radiation syndrome.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell therapeutic company
focused on developing products to treat serious medical conditions in
the inflammatory, orthopedic and cardiovascular areas. The Company's
pipeline of internally developed biologic drug candidates under
evaluation includes Prochymal for inflammatory, autoimmune, and
cardiovascular indications, as well as Chondrogen for arthritis in the
knee. Osiris is a fully integrated company, with capabilities in
research, development, manufacturing, and distribution of stem cell
products. Osiris has developed an extensive intellectual property
portfolio to protect the company's technology including 49 U.S. patents
each having one or more foreign counterparts. Osiris, Prochymal and
Chondrogen are registered trademarks of Osiris Therapeutics, Inc. More
information can be found on the company's website, www.Osiris.com.
(OSIR-G)
In November 2008, Osiris and Genzyme announced a strategic alliance for
the development and commercialization of Prochymal and Chondrogen. Under
the terms of the agreement, Osiris retains commercialization rights to
Prochymal and Chondrogen in the United States and Canada, with Genzyme
having these rights in all other countries.
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 and the ability to successfully
navigate these 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 Prochymal, Chondrogen and our other MSC and biologic drug
candidates; our cash needs; patents and proprietary rights; the safety
and ability of our potential products to treat disease and the results
of our scientific research; 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. Risks and
uncertainties related to the sale of our Osteocel assets and related
transactions include typical business transactional risks, the risk of
changing relationships with customers, suppliers or employees; and the
risk that we may not be able to fully perform or generate or receive
milestone payments. Risks and uncertainties related to our Collaboration
Agreement with Genzyme for the development and commercialization of
Prochymal and Chondrogen include, among others: typical business
transactional risks; risks related to product development and clinical
trial design, performance and completion; uncertainty of the success of
Prochymal and Chondrogen in clinical trials and their ability to treat
disease; Genzyme’s early termination and opt-out rights; the ability of
Osiris and Genzyme to successfully navigate regulatory requirements and
to manufacture and commercialize products; and the uncertainty as to our
ability to successfully perform under the collaborative arrangement and
earn milestone and royalty payments thereunder. 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 and other
Periodic Reports filed on Form 10-Q, 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.