Orbsen’s approach to ORBCEL™ development has been to combine internal testing with rigorous independent validation of the technology. Within the European Union Framework 7 (EU FP7) funded REDDSTAR and MERLIN programs, the ORBCEL™ product was tested head-to-head against the traditional plastic adherent (PA) cells in eight different pre-clinical animal models across eight different research centers. Orbsen’s product demonstrated an equivalent or better therapeutic response in models of five diabetic complications (nephropathy, neuropathy, retinopathy, cardiomyopathy and wound healing); acute respiratory distress syndrome (ARDS); rheumatoid arthritis and inflammatory liver disease. This validation approach has led to rapid progression of ORBCEL™ from a discovery and pre-clinical phase to four EU FP7 funded clinical programs within just three years. ORBCEL™ will have completed four early phase clinical studies and will be ready for Phase 3 pivotal testing within several years.
Intellectual Property: Orbsen’s initial patent application was filed in 2012 and was granted by the EPO in 2015, providing 17 years of commercial protection to 2032. Our intellectual property covers Orbsen’s cellular therapy compositions, efficient processes for their extraction, purification, manufacturing scale-up and the broad range of applications for which they are being developed in key markets including the United States, Canada, Europe, Australia, Japan, Russia, India and China.
Focused Pipeline: Orbsen is developing a range of products derived from the Company’s proprietary ORBCEL™ technology platforms with pre-clinical and early-stage trials in its core therapeutic areas: Diabetic vascular complications where ORBCEL™ products are being developed for both local and systemic application; and acute inflammatory and autoimmune diseases with an underlying inflammatory and immunologic etiology, which may be addressed by intravenous delivery of cell therapy for immunomodulation.