JDRF Partners with Osiris on a Phase II Trial to Evaluate an Immunomodulatory Cell Therapy Product For Type 1 Diabetes
New York, NY – October 25, 2007 – The Juvenile Diabetes Research Foundation announced today a partnership with Osiris Therapeutics, Inc. (NASDAQ:OSIR) to support a Phase II clinical trial using Prochymal, an immunomodulatory cell therapy product, to preserve and regenerate insulin-producing cells in patients newly diagnosed with type 1 diabetes .
JDRF, the world’s largest charitable funder of diabetes research, said that it would fund Osiris’ proof-of-concept trial of Prochymal™, a formulation of immunomodulatory adult bone marrow-derived mesenchymal stem cells, in type 1 diabetes.. Prochymal™ is currently being evaluated by Osiris in Phase III trials for Graft-vs-Host Disease (GVHD) and Crohn’s Disease.
Maryland-based Osiris Therapeutics is a leading cell-based therapeutic company, whose focus has been on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas.
“The proposed research from Osiris presents a novel approach for the development of a immunomodulatory cellular therapy, and supports the goals of our program to halt or reverse the autoimmune attack that causes type 1 diabetes,” said Teodora Staeva-Vieira, Ph.D., Director of the Autoimmunity Program at JDRF.
JDRF is partnering with Osiris through its innovative Industry Discovery and Development Partnership (IDDP) program. Through the IDDP program, JDRF partners with pharmaceutical, biotech, and medical device businesses with the goal to accelerate the development and commercialization of drugs, treatments, technologies, and other therapeutics leading to a cure, reversal, or prevention of type 1 diabetes and its complications. Currently, JDRF has funded applied diabetes projects at 22 companies, including Osiris.
“Prochymal has shown promise as a therapy for severe immune mediated conditions including Crohn’s Disease and GHVD,” said C. Randal Mills, Ph.D., President and CEO of Osiris Therapeutics. “Now that the product has advanced to the final stages of clinical trials, it is appropriate to evaluate related conditions such as type 1 diabetes. We are excited to partner with JDRF to conduct this groundbreaking proof-of-concept trial in new onset type 1 diabetes.”
Diabetes is a chronic, debilitating disease affecting every organ system. There are two major types of diabetes: type 1 and type 2. Type 1 diabetes is an autoimmune disease in which the pancreas stops producing insulin, a hormone that enables people to turn food into energy. Type 1 diabetes usually strikes in childhood, adolescence, or young adulthood, but lasts a lifetime. People with type 1 diabetes must take multiple injections of insulin daily or continuous infusion of insulin through a pump just to survive. Taking insulin does not cure any type of diabetes nor prevent the possibility of its eventual and devastating effects: kidney failure, blindness, nerve damage, amputation, heart attack, and stroke.
About JDRF
JDRF was founded in 1970 by the parents of children with type 1 diabetes -- a disease that strikes children, adolescents, and adults suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1.16 billion to diabetes research worldwide. More than 85 percent of JDRF's expenditures directly support research and research-related education. JDRF's mission is constant: to find a cure for type 1 diabetes and its complications through the support of research. For more information please visit www.jdrf.org
About Osiris Therapeutics, Inc.
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 in Phase III clinical trials for both Graft versus Host Disease and Crohn's disease and is the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product. Osiris has also partnered with Genzyme Corporation to develop Prochymal(TM) as a medical countermeasure to nuclear terrorism and other radiological emergencies. The Company's pipeline of internally developed biologic drug candidates under evaluation also includes Chondrogen(TM) for arthritis in the knee, and Provacel(TM), for repairing heart tissue following a heart attack. 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 211 foreign patents owned or licensed. More information can be found on the company's website, www.Osiris.com.
Contacts:
Osiris Therapeutics, Inc.
Stacey Holifield/Andrew Law
Media Relations
(781) 684-0770
Osiris@schwartz-pr.com
Juvenile Diabetes Research Foundation
Brenda Cheung
Media Relations
(212) 479-7626
bcheung@jdrf.org