Key Developments For Osiris Therapeutics Inc
Osiris Therapeutics Inc (OSIR.O) (Consolidated Issue listed on NASDAQ Global Market)
Osiris Therapeutics, Inc. Achieves $15 Million Payment From NuVasive, Inc.
Osiris Therapeutics, Inc. announced that it has achieved a $15 million payment from NuVasive, Inc. related to the sale of the Osteocel business. Triggering the payment, NuVasive recently reached $35 million in cumulative sales of Osteocel. With this final payment, Osiris has realized the full $85 million value from the sale of its Osteocel business to Nuvasive.
Osiris Therapeutics, Inc. Announces Change In CFO-Form 8-K
Osiris Therapeutics, Inc. announced in its Form 8-K that, On September 8, 2009, Richard W. Hunt, who has served as Chief Financial Officer (CFO) of the Company since July 2008, resigned to pursue new professional opportunities, effective immediately. Upon Mr. Hunt's departure, Philip R. Jacoby, Jr., the Company's Vice President of Finance, Corporate Secretary and Chief Accounting Officer since April 2005, will assume the additional role of CFO.
Osiris Therapeutics, Inc. Announces Preliminary Results For Prochymal Phase III GvHD Trials
Osiris Therapeutics, Inc. announced preliminary results for two phase III trials evaluating Prochymal for the treatment of acute graft versus host disease (GvHD). Prochymal showed significant improvements in response rates in difficult-to-treat liver and gastrointestinal GvHD, however neither trial reached its primary endpoint. Protocol 265 was designed to evaluate Prochymal as a first-line agent for the treatment of acute GvHD in combination with steroid therapy. The majority of patients in this trial were suffering from skin GvHD, which responded significantly better to steroids than had been previously reported in controlled trials. This high response rate to standard of care diminished the potential for Prochymal to demonstrate an effect. Based upon the results of the steroid-refractory GvHD trial, Osiris plans to file an amendment with the FDA to the current expanded access program, broadening the entry criteria to include patients with severe GvHD of the liver.
Osiris Therapeutics, Inc. Creates Biosurgery Division
Osiris Therapeutics, Inc. announced the creation of a new Biosurgery Division focused on developing and marketing high-end biological products for use in surgical procedures. The Company intends to build on its first generation implantable product, Osteocel, which it launched in July of 2005.
Osiris Therapeutics, Inc. Achieves Payment For Progress Developing Stem Cell Therapy for Type 1 Diabetes
Osiris Therapeutics, Inc. announced that that it has achieved a $750,000 payment from the Juvenile Diabetes Research Foundation (JDRF) for progress made on a Phase II clinical trial evaluating Prochymal, an adult mesenchymal stem cell (MSC) therapy, as a treatment for patients recently diagnosed with type 1 diabetes. The payment was triggered after one-half of the patients in the 60-participant study were enrolled. The trial is also being expanded to include pediatric patients, opening enrollment to patients between 12 and 35 years of age. Osiris and the JDRF entered into a partnership in 2007 for the development of Prochymal as a therapy for newly diagnosed type 1 diabetes mellitus. In type 1 diabetes, the patient`s own immune system attacks and destroys insulin-producing islet cells in the pancreas, resulting in the loss of blood-sugar control. Currently, there are no approved treatments for altering the rate of destruction of these critical islet cells, called beta cells. Preclinical studies first conducted by researchers at Genzyme found that MSCs may have the ability to delay the progression of type 1 diabetes by preserving beta cell function. In clinical trials, Prochymal has already shown promise for treating GvHD, a severe immune-mediated disease. Prochymal is currently in Phase III trials for acute and steroid-refractory GvHD, indications that have been granted Fast Track status by the FDA.
