Mast Therapeutics Inc. announced that, in line with prior guidance, it has initiated patient enrollment in a sub-study within EPIC, its pivotal Phase 3 study of MST-188 in sickle cell disease, to investigate and quantify the effect of MST-188 on tissue oxygenation, which will be measured utilizing a non-invasive, FDA-approved device. MST-188 has been shown to reduce viscosity and adhesive frictional forces in blood and improve microvascular blood flow. Improvements in the flow of oxygen-carrying blood to tissues and organs can be expected to improve tissue oxygenation, shorten the duration of vaso-occlusive crisis, and limit tissue damage and end-organ dysfunction and failure.
Brian Culley, chief executive officer, said: “Organ failure, which is the leading cause of premature death in adults with sickle cell disease, is thought to be the consequence of a lifetime of repeated vaso-occlusive events and the resulting ischemia. We believe that measuring effects on microvascular blood flow and tissue oxygenation during vaso-occlusive crisis will be useful to understanding MST-188’s potential to improve long-term outcomes for sickle cell patients where multi-decade, survival trials are impractical. MST-188 has already demonstrated an ability to improve microvascular blood flow. Now, this sub-study will demonstrate whether MST-188 also improves tissue oxygenation. Together, these data will provide insight into the potential for MST-188 to reduce end-organ failure and associated premature death in individuals with sickle cell disease.”
The sub-study will enroll patients who are concurrently randomized in the EPIC clinical trial and will be conducted at selected EPIC sites in the United States. The primary objective is to evaluate the effects of MST-188 on tissue oxygenation in subjects with sickle cell disease who are experiencing a vaso-occlusive crisis.
Date: June 16, 2014
Source: Mast Therapeutics
