Advertisement
Mast Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has designated MST-188 for the treatment of acute limb ischemia as an orphan drug.
 
Brian M. Culley, chief executive officer, said: "This designation represents further progress in our development of MST-188 as an adjunct therapy for life-threatening conditions treated with existing thrombolytic agents, such as tPA. As we previously reported, we are on track to initiate a Phase 2, clinical proof-of-concept study in acute limb ischemia in early 2014. If this study demonstrates that MST-188 improves the 'clot busting' activity of tPA in acute limb ischemia, we believe it would provide the data to design a registrational phase 3 study in that orphan disease, as well as generate data to support development in indications with even larger market opportunities, such as stroke."
 
The company is enrolling subjects in EPIC, a pivotal Phase 3 study of MST-188 in sickle cell disease, a genetic blood disorder in which sickled cells cause blood flow problems, which can lead to severe pain, irreversible organ damage and early death. The company plans to initiate a Phase 2 clinical study of MST-188 in acute limb ischemia, a complication of peripheral arterial disease, in early 2014.
 
Date: November 13, 2013
Advertisement
Advertisement