AFTER the successful completion of clinical studies, the German biotech company Orthogen AG (Dusseldorf) intends to build up a Europe-wide distribution of OrthokineŽ. OrthokineŽ is a medical device for the production of autologous conditioned serum; containing anti-inflammatory cytokine antagonists and growth factors.
Two universities performed randomised double-blind studies demonstrating its high efficacy and safety in the therapy of osteoarthritis of the knee and low back pain. "Due to its beneficial side effect profile, OrthokineŽ therapy represents an efficient alternative to steroids, hyaluronic acids and analgesics like cox-II inhibitors," said Prof. Dr. Peter Wehling, CEO of Orthogen, recently.
After the build up of the Germany-wide sales in the last year, the molecular orthopedics specialist company intends to extend its activities to the EU market. FDA application for the sales in the US market is filed.
Orthogen AG works currently on a novel stem cell technology for the regeneration of cartilage from non-embryonic stem cells.
First clinical results on humans demonstrate feasibility of the method. It is intended to replace time-consuming autologous chondrocyte implantation (ACI) by this new procedure.
A new immune-modulatory therapeutic approach for the treatment of rheumatoid arthritis with so-called exosomes is also under development. Exosomes are highly efficient anti-inflammatory nano-particles.
Clinical studies demonstrated feasibility and safety of the method. Further clinical studies are intended to show long-term-efficacy. This method could become a highly efficient and safe alternative to cytokine antagonists produced with recombinant techniques (e.g. Anti-TNF).
Orthogen AG is a biopharmaceutical group of companies which has worked for twelve years in the field of molecular orthopedics.