Prochymal(TM) Demonstrates Lasting Benefit in Heart Attack Patients;
Osiris Receives FDA Clearance to Start Phase II Trial
One Year Results of Phase I Trial Continue to Demonstrate Safety and
Persistent Cardiac Improvement
COLUMBIA, Md.--(BUSINESS WIRE)--Feb. 26, 2008--Osiris
Therapeutics, Inc. (NASDAQ:OSIR) today announced that interim results
at the one year time point for the Company's Phase I trial evaluating
Prochymal(TM) for the treatment of heart attack patients continued to
demonstrate a strong safety profile and statistically significant
improvement in heart function. Based upon the positive results from
this 53-patient, double-blind, placebo-controlled trial, the Company
has received approval from the Food and Drug Administration (FDA) to
initiate a Phase II trial.
"This early stage trial exceeded our expectations for both safety
and efficacy," said C. Randal Mills, Ph.D., President and Chief
Executive Officer of Osiris. "These data support our pre-clinical
results and suggest that in acute myocardial infarction, early
treatment with Prochymal can alter the course of disease. Based on
this encouraging data, we look forward to promptly advancing Prochymal
in this exciting, multi-billion dollar market."
Prochymal for Heart Attack Patients: An Interim Analysis at One
Year
The trial collected one-year magnetic resonance imaging (MRI) data
on left ventricular ejection fraction (LVEF), which reflects the
fraction of blood pumped out of a ventricle with each heart beat. This
is a commonly used measurement of overall heart function and typically
declines after injury to the heart, as often occurs in heart attack
patients. Patients with significantly compromised LVEF progress to
heart failure.
Key results include:
-- The Prochymal treatment group achieved a statistically
significant 5.2 point increase in LVEF over baseline (P =
0.021). The placebo group experienced a 1.8 point improvement
in LVEF over baseline, which was not statistically
significant.
-- Patients with more severe myocardial infarction, defined as a
baseline LVEF of 45 or less, demonstrated even greater
effects. The Prochymal-treatment group showed a 6.5 point
improvement one-year post-treatment, compared to a 1.9 point
increase in the placebo group.
-- Prochymal treated patients continued to experience fewer
adverse events, at a rate of 6.1 per patient, compared to 8.0
per placebo-group patient.
-- No serious adverse events were attributed to Prochymal.
"First and foremost, the safety data generated in this trial were
outstanding and add to the growing body of evidence demonstrating that
Prochymal can be used to treat patients in the acute setting," said
Joshua Hare, M.D., lead investigator for the Prochymal cardiac study.
Dr. Hare is the Louis Lemberg Professor of Medicine at the Miller
School of Medicine, University of Miami; Chief of the Cardiovascular
Division; and Director of the School's Interdisciplinary Stem Cell
Institute. "The data further suggest that the greater the cardiac
damage, the greater the potential benefit from Prochymal. We are very
excited about advancing Prochymal into Phase II, and the prospect of
ushering in a new era in the treatment of myocardial infarction."
The one year interim analysis was performed as part of the full
two year follow-up period to the trial, and as a result, contains only
limited data. A more comprehensive data set will be available at the
two year time-point, which marks the conclusion of the trial.
Prochymal, a patented formulation of adult stem cells, is
currently in Phase III clinical trials for the treatment of Graft vs.
Host Disease and Crohn's Disease and is in a Phase II trial for type 1
diabetes. Osiris was recently awarded a $224.7 million contract for
the development and stockpile of Prochymal by the Defense Department
for the treatment of acute radiation syndrome. The Company recently
regained exclusive world-wide rights to cardiovascular indications for
the product and as a result, discontinued using the cardiac specific
brand name Provacel.
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 and for the protection of pancreatic
islet cells in patients with type 1 diabetes. 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)
Osiris Receives FDA Clearance to Start Phase II Trial
One Year Results of Phase I Trial Continue to Demonstrate Safety and
Persistent Cardiac Improvement
COLUMBIA, Md.--(BUSINESS WIRE)--Feb. 26, 2008--Osiris
Therapeutics, Inc. (NASDAQ:OSIR) today announced that interim results
at the one year time point for the Company's Phase I trial evaluating
Prochymal(TM) for the treatment of heart attack patients continued to
demonstrate a strong safety profile and statistically significant
improvement in heart function. Based upon the positive results from
this 53-patient, double-blind, placebo-controlled trial, the Company
has received approval from the Food and Drug Administration (FDA) to
initiate a Phase II trial.
"This early stage trial exceeded our expectations for both safety
and efficacy," said C. Randal Mills, Ph.D., President and Chief
Executive Officer of Osiris. "These data support our pre-clinical
results and suggest that in acute myocardial infarction, early
treatment with Prochymal can alter the course of disease. Based on
this encouraging data, we look forward to promptly advancing Prochymal
in this exciting, multi-billion dollar market."
Prochymal for Heart Attack Patients: An Interim Analysis at One
Year
The trial collected one-year magnetic resonance imaging (MRI) data
on left ventricular ejection fraction (LVEF), which reflects the
fraction of blood pumped out of a ventricle with each heart beat. This
is a commonly used measurement of overall heart function and typically
declines after injury to the heart, as often occurs in heart attack
patients. Patients with significantly compromised LVEF progress to
heart failure.
Key results include:
-- The Prochymal treatment group achieved a statistically
significant 5.2 point increase in LVEF over baseline (P =
0.021). The placebo group experienced a 1.8 point improvement
in LVEF over baseline, which was not statistically
significant.
-- Patients with more severe myocardial infarction, defined as a
baseline LVEF of 45 or less, demonstrated even greater
effects. The Prochymal-treatment group showed a 6.5 point
improvement one-year post-treatment, compared to a 1.9 point
increase in the placebo group.
-- Prochymal treated patients continued to experience fewer
adverse events, at a rate of 6.1 per patient, compared to 8.0
per placebo-group patient.
-- No serious adverse events were attributed to Prochymal.
"First and foremost, the safety data generated in this trial were
outstanding and add to the growing body of evidence demonstrating that
Prochymal can be used to treat patients in the acute setting," said
Joshua Hare, M.D., lead investigator for the Prochymal cardiac study.
Dr. Hare is the Louis Lemberg Professor of Medicine at the Miller
School of Medicine, University of Miami; Chief of the Cardiovascular
Division; and Director of the School's Interdisciplinary Stem Cell
Institute. "The data further suggest that the greater the cardiac
damage, the greater the potential benefit from Prochymal. We are very
excited about advancing Prochymal into Phase II, and the prospect of
ushering in a new era in the treatment of myocardial infarction."
The one year interim analysis was performed as part of the full
two year follow-up period to the trial, and as a result, contains only
limited data. A more comprehensive data set will be available at the
two year time-point, which marks the conclusion of the trial.
Prochymal, a patented formulation of adult stem cells, is
currently in Phase III clinical trials for the treatment of Graft vs.
Host Disease and Crohn's Disease and is in a Phase II trial for type 1
diabetes. Osiris was recently awarded a $224.7 million contract for
the development and stockpile of Prochymal by the Defense Department
for the treatment of acute radiation syndrome. The Company recently
regained exclusive world-wide rights to cardiovascular indications for
the product and as a result, discontinued using the cardiac specific
brand name Provacel.
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 and for the protection of pancreatic
islet cells in patients with type 1 diabetes. 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)