Osiris Therapeutics, Inc. (NASDAQ:OSIR)
today announced that it has achieved $2 million in milestone payments
from the Juvenile Diabetes Research Foundation (JDRF) for progress made
on a Phase II clinical trial evaluating Prochymal,
a mesenchymal stem cell (MSC) therapy, for patients recently diagnosed
with type 1 diabetes. The payments were triggered when Osiris
accomplished certain clinical and regulatory milestones including
initiating patient treatments.
“Due to the long-term effects of type 1
diabetes, there is a critical need to develop more effective therapies,”
said Jay S. Skyler, M.D., Professor of Medicine and Associate Director
of the Diabetes Research Institute at the University of Miami. “Our
ultimate goal with this research is to develop a treatment that we could
give a patient at the onset to safely halt progression of the disease
and preserve enough islet cell function to avoid the need for insulin
administration all together.”
Type 1 diabetes is a disorder where a patient’s
own immune system attacks and destroys insulin-producing islet cells in
the pancreas, resulting in the loss of control of blood sugar.
Currently, there are no approved treatments for preventing the
progression of the disease. Preclinical studies suggest MSCs have the
ability to delay the progression of type 1 diabetes. In human clinical
trials Prochymal has already show great promise for treating Graft vs.
Host disease (GvHD) and Crohn’s disease, both
severe immune-mediated diseases. Prochymal is currently in Phase III
trials for both disease and has been given Fast Track status by the Food
and Drug Administration.
“Because Prochymal has been shown to home to
sites of inflammation and inhibit immune system attack in other disease
states, we are very excited about evaluating its potential to alter the
course of this debilitating condition,” said
Kashif Latif, M.D., Medical Director of the AM Diabetes and
Endocrinology Center and Assistant Professor of Medicine at the
University of Tennessee in Memphis. “Our
treatment of the first patient in this landmark trial is an important
step towards examining the long-term therapeutic benefit of Prochymal
for the improvement of pancreatic insulin production.”
For more information about the trial and how to participate, please
visit the Osiris website at www.Osiris.com.
About the Phase II Type 1 Diabetes Trial
The Phase II trial is evaluating the safety and efficacy of Prochymal in
preserving insulin production in patients 18-30 years old recently
diagnosed with type 1 diabetes. The design is a double-blind,
placebo-controlled, multicenter trial with a target enrollment of 60
patients.
