Osiris Recieves FDA Fast Track status and Clearance to Start Phase III trials for Crohn’s Disease Stem Cell Therapy

Osiris Therapeutics, Inc. has announced that PROCHYMAL™ has received Fast Track designation from the U.S. Food and Drug Administration, expediting the development of the stem cell treatment for Crohn’s Disease that does not respond to standard therapies.

Additionally, Osiris has received clearance to conduct a Phase III clinical trial using PROCHYMAL to treat this resistant form of Crohn’s Disease.

Osiris says that the Phase III program was developed in consultation with FDA, and if successful, will be the last phase of testing before the company seeks full approval for Crohn’s Disease.

Osiris recently reported positive clinical trial results evaluating PROCHYMAL for treatment resistant Crohn’s Disease and Graft versus Host Disease, or GVHD.

According to the Company, Crohn’s Disease is the second indication for which it has obtained Fast Track status and has advanced into Phase III trials.

Osiris claims that it was the first company to receive Fast Track status for a ready to use stem cell treatment, when in 2005, FDA granted PROCHYMAL Fast Track status for the treatment of GVHD. Since receiving Fast Track, Osiris has advanced the product through Phase II testing and is currently enrolling patients in a Phase III trial for resistant GVHD.

“PROCHYMAL’s unique mechanism of action may represent a new class of anti-inflammatory agent,” said Jane Onken, M.D., Director of the Inflammatory Bowel Disease Clinic and Associate Professor of Medicine at the Duke University School of Medicine.

“Laboratory data indicate that the stem cells in PROCHYMAL respond according to the level of inflammation present. When there are higher concentrations of inflammatory signals, the cells produce a stronger anti-inflammatory effect. When there is no inflammation, the anti-inflammatory effect is turned off."

"It is our hope that this proportional response will lead to a treatment that avoids many of the dangerous side effects associated with systemic immunosuppressive therapy and provide us with a safer alternative for treating patients with serious inflammatory diseases,” he continued.

“We are very pleased with the tremendous progress that the entire PROCHYMAL team has made over the past two years,” said C. Randal Mills, Ph.D., President and CEO.

“Moving the program into Phase III and receiving Fast Track status are key components in our plan to expand the market applicability of this exciting stem cell technology as quickly as possible. Our vision is to leverage the unique properties of stem cells and create a new treatment paradigm, applicable to a broad spectrum of inflammatory disease.”