Osiris Therapeutics, Inc. (BALTIMORE, Md.), a leading adult stem cell therapeutic company focused on developing and marketing products to treat medical conditions in the inflammatory, orthopaedic, and cardiovascular areas, announced that underwriters sold 3.5 million shares of its common stock at a price of $11.00 per share, achieving the lower end of the targeted share price for its initial public offering and raising $38.5 million. Subsequent to the IPO, Osiris announced that Earl R. Fender joined the company in the new role of Vice President and General Manager for Orthopedics. Most recently, Mr. Fender served for more than 10 years with DePuy Spine, Inc., a Johnson & Johnson company, holding positions as Vice President, Sales; US President; and finally as Worldwide President. Additionally, Lode Debrabandere, PhD, joined the Company in the new role of Vice President and General Manager for Inflammatory Diseases. Prior to joining Osiris, Dr. Debrabandere served for more than 4 years with Bristol-Myers Squibb as Vice President of Strategic Marketing for Neuroscience and Infectious Diseases.
The 14-year-old company has developed technologies for harvesting and expanding adult stem cells from the bone marrow of normal healthy adult volunteer donors. These Mesenchymal Stem Cells (MSCs) can engraft and selectively differentiate, based on the tissue environment, to such lineages as muscle, bone, cartilage, marrow stroma, tendon, and fat. As a result of their cellular origin and phenotype, these cells do not provoke an immune response, allowing for the development of products derived from unrelated human donors. Upon a 10,000-fold expansion, several thousand treatments can be produced from MSCs isolated from a single donor.
Osiris currently markets and sells OsteocelR (a viable bone matrix product containing stem cells), the first biologic product to provide all three bone growth properties: osteoconduction, osteoinduction, and osteogenesis, allowing orthopaedic surgeons to provide their patients with bone growth conditions without the discomfort and complications of autograft harvesting.
Osiris has three product candidates in clinical trials. The most advanced investigational therapy, Prochymalâ„¢, is entering phase III clinical trials and is the only stem cell therapeutic currently designated by the US FDA as both an Orphan Drug and a Fast Track product. The company's pipeline of internally developed biologic drug candidates under evaluation also includes Chondrogenâ„¢, for regenerating cartilage in the knee, and Provacelâ„¢, for repairing heart tissue following a heart attack.
Osiris has recently completed patient enrollment in a phase II trial using Prochymal to explore whether it reduces the symptoms of moderate-to-severe Crohn's disease. The objective of this study is to evaluate two dose levels of Prochymal in patients who have not responded to standard therapy and who have not received infliximab (Remicade®) within the 90 days prior to Prochymal treatment. Prochymal also is undergoing a phase III study for the treatment of steroid-refractory acute graft-versus-host-disease (GVHD), a life-threatening disease afflicting patients who have received a bone marrow transplant.
Osiris has completed enrollment in a phase I/II animal study for its second product candidate, Chondrogen, an injection of stem cells formulated to repair damaged tissue in the knee joint and prevent the progression of arthritis in patients undergoing meniscectomy. The objective of this study is to evaluate Chondrogen for meniscal regeneration following partial meniscectomy in patients requiring removal of at least 50% of the injured portion of the medial meniscus to treat meniscal tears and/or degeneration. In MSC-treated animals, surgically removed meniscal tissue was regenerated, the cartilage surface was protected, and lessened joint damage was observed in comparison with control animals. These benefits persisted in animal models at least through 1 year.
Finally, Osiris has completed enrollment in a phase I clinical trial of Provacel, a formulation of stem cells for the treatment of damaged myocardium following acute myocardial infarction.
— A. Techman
E-mail any comments to .