Additional Relevant Details "This is a significant step in the development of another drug candidate utilizing our CTP technology," commented Phillip Frost, MD, Chairman and Chief Executive Officer of OPKO. "Later this year, we expect to initiate a second Phase 2a trial for Factor VIIa-CTP in a subcutaneous formulation that, if successful, could provide prophylactic therapy to prevent bleeding episodes and thereby change the treatment paradigm for patients with hemophilia."
Currently, Factor VIIa therapy is available only as an intravenous (IV) formulation which, due to Factor VIIa's short half-life, requires multiple infusions to treat a bleeding episode in hemophilia A or B patients with inhibitors. In addition, frequent infusions are onerous when used as prophylactic therapy, especially for children. Pre-clinical studies of intravenous and subcutaneous formulations of our product in hemophilic animal models demonstrated its duration of action and significantly increased survival.