BirchBioMed is the clinical development and commercialization vehicle for two low-cost, late-stage technologies with both short-term and long-term revenue positions. FS2,our proprietary and patented lead drug candidate,marks a significant medical breakthrough in the treatment of scars and autoimmune diseases and has the potential to impact millions of patients worldwide.
First identified as a drug candidate for clinical trials by world-renowned investigators at UBC, FS2 demonstrated during pre-clinical trials that it is the first drug to successfully target scarring on the molecular level. That means it essentially stops scarring that results from the body over-repairing after an injury, surgery or disease, and it does so at the inception of both external and internal scarring. What is significant about this result is that, to date, there has been no therapeutic agent approved by the FDA, Health Canada, or any other international regulatory agency to target the molecular aspects of scarring. Nevertheless, there are a plethora of costly cosmetic treatments on the market today that show little – if any — efficacy in the treatment of scarring. Meanwhile, the medical alternatives are costly, painful and focused on healing wounds, not on preventing and eliminating scars.
During research into the anti-scarring capabilities of FS2, our investigators discovered during pre-clinical investigation that FS2 in conjunction with cell therapy reverses a number of autoimmune diseases in animal models. The combined cell therapy, which uses a single dose of allogeneic cells injected into the patient, and oral drug administration, is called “AI-001”. To date, AI-001 has demonstrated proof-of-principal in animal models for treatment (complete remission) of Type-1 Diabetes, Psoriasis and Alopecia (disfiguring and psychologically damaging hair loss). Moreover, by using cell therapy in combination with oral administration of FS2, we will be able to strategically engage in phase II trials for orphan scarring diseases and one of any number of other autoimmune diseases for which it has pre-clinical efficacy data (Type 1 Diabetes, Alopecia, Psoriasis).