First-in-Class Stem Cell Therapy Now Being Evaluated to Treat Fourth
Leading Cause of Death
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 FEV1
% predicted, a measure of pulmonary function, versus only a 6 point
improvement in patients treated with placebo (p <
0.05).
