Osiris Therapeutics, Inc. (NASDAQ:OSIR)

Osiris Therapeutics, Inc. is a stem cell therapeutic company, which is focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas.

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Osiris Therapeutics, Inc. began operations on December 23, 1992 and was a Delaware corporation until, with approval of stockholders; it reincorporated as a Maryland corporation on May 31, 2010. The Company is a stem cell therapeutic company, which is focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic and cardiovascular areas. It is a fully integrated company, having developed capabilities in research, development, manufacturing, marketing and distribution of stem cell products. Its biologic drug candidates utilize mesenchymal stem cells, or MSCs. The Company currently has eight clinical trials ongoing, including four Phase III clinical trials. It is conducting Phase III trials for Prochymal, its biologic drug candidate, for: the treatment of steroid refractory acute GvHD; first line treatment of acute GvHD; biologics refractory Crohn's disease; and acute radiation syndrome, which is under the Animal Rule. Prochymal is the company's biologic drug candidate that is being used to treat medical conditions in a number of indications. Prochymal is being evaluated in Phase III clinical trials for three indications, including first line and steroid refractory acute graft versus host disease (GvHD) and Crohn's disease, and is the only stem cell therapeutic currently designated by the FDA as both an Orphan Drug and Fast Track product. Prochymal is also being developed for the repair of heart tissue following a heart attack and for the protection of pancreatic islet cells in patients with type 1 diabetes, for the treatment of Chronic Obstructive Pulmonary Disease (COPD) and for the repair of gastrointestinal injury resulting from radiation exposure. The company has received Fast Track Status from the FDA for each of these pivotal Phase III trials for Prochymal. It has initiated Phase II clinical trials for Prochymal for both type 1 diabetes and acute myocardial infarction. Its two biologic drug candidates, Prochymal and Chondrogen, utilize human mesenchymal stem cells, also referred to as MSCs. MSCs can selectively differentiate, based on the tissue environment, into various tissue lineages such as bone, muscle, fat, tendon, ligament, cartilage and bone marrow stroma. Its biologic drug candidate is being evaluated in clinical trials for a number of indications including acute GvHD, Crohn's disease, acute myocardial infarction, type 1 diabetes and gastrointestinal injury resulting from radiation exposure (animal rule). Prochymal is currently designated by the FDA as both an Orphan Drug and Fast Track product; and Chondrogen is its biologic drug candidate for knee repair. Chondrogen, a preparation of adult MSCs formulated for direct injection into the knee, regenerated meniscus and prevented osteoarthritis in animal models. As described further below, it completed a Phase 1/2 clinical trial for Chondrogen, designed to evaluate the safety and preliminary efficacy in patients following surgery to remove torn meniscus. The current standard of care for significant injuries to the meniscus is partial meniscectomy surgery, in which the damaged portion of the meniscus is permanently removed. As noted in a 1999 article in the journal Sports Medicine, patients after meniscectomy are 10 to 15 times more likely to develop osteoarthritis, a highly debilitating orthopedic condition. The company has developed an intellectual property portfolio to protect its technology in the United States and a number of foreign countries, including 50 U.S. and 156 foreign patents owned or licensed.