Platform Technology
Ensign has obtained an exclusive license to the ProGel technology platform from the University of Nebraska Medical Center. The unique drug formulation provides sustained and localized delivery of therapeutic agents at sites of tissue and organ pathology. The platform is a macromolecular prodrug that possesses unique thermoresponsive properties. The polymeric prodrugs are water-soluble at a reduced temperature (e.g., 4 °C) and at elevated temperature (e.g., 37 °C) the solution undergoes a thermo-responsive phase-transition to form a hydrogel. This newly discovered property facilitates the delivery of the solution-phase ProGel via injection. At body temperature the ProGel transitions into a hydrogel that undergoes gradual dissolution, releasing the prodrug at sites of local pathology. The free prodrug is then taken up by resident cells followed by intracellular processing that leads to a regulated and sustained release of the active drug moiety providing sustained therapeutic benefit.
The primary therapeurtic indication for the the ProGel technology is for management of osteoarthritis (OA) pain. We have shown that the HPMA copolymer-based dexamethasone prodrug ProGel-Dex provides sustained amelioration of joint pain in multiple animal models of osteoarthritis, including the monoiodoacetate (MIA)-induced and the surgical destabilization of the medial meniscus (DMM) OA models. Based on these favorable results, the development and translation of ProGel-Dex for clinical management of OA pain is the current focus of Ensign product development. The platform delivery technology is optimally designed for clinical use in a specrum of musculoskeletal disorders associated with pain and inflammation, including chronic low back pain associated with spinal facet and disc arthropathy, tendonitis, bursitis and certain forms of inflammatory arthritis. Importantly, the ProGel formulation is a platform technology that can also be used to deliver other drug classes (e.g., statins, antioxidants, opioids, chemotherapeutics, hormones, etc.). The promising clinical application of these new prodrug classes may be used to accelerate fracture repair or stimulate periodontal bone regeneration, as an adjunct therapy for cancer treatment, as a long-term hormone therapy for high risk pregnancy, and as a long-term non-addictive opioid treatment for post-operative pain management. Clearly, there is a rich pipeline of products that can be developed based on the ProGel technology.