The primary endpoint of the trial will be the measurement of
C-peptide produced after glucose stimulation. This test is frequently
used in diabetic patients to assess the pancreas’
ability to produce insulin. Patients will be followed for safety and
efficacy for a total of 2 years.
About Juvenile Diabetes Research Foundation
JDRF is the leading charitable funder and advocate of type 1 (juvenile)
diabetes research worldwide. The mission of JDRF is to find a cure for
diabetes and its complications through the support of research. Type 1
diabetes is a disease which strikes suddenly and requires multiple
injections of insulin daily or a continuous infusion of insulin through
a pump. Insulin, however, is not a cure for diabetes, nor does it
prevent its eventual and devastating complications which may include
kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with type 1 diabetes,
JDRF has awarded more than $1.16 billion to diabetes research, including
more than $137 million in FY2007. In FY2007, the Foundation funded 700
centers, grants and fellowships in 20 countries.
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 for regenerating bone in orthopedic
indications. Prochymal 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 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 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 including 47 U.S. patents each having one or
more foreign counterparts. Osiris, Prochymal, Chondrogen and Osteocel
are registered trademarks of Osiris Therapeutics, Inc.
