Nov. 13, 2013
Mast Therapeutics, Inc.
(NYSE MKT: MSTX) today 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."
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in
, California. The Company is leveraging the MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop MST-188, its lead product candidate, for serious or life-threatening diseases with significant unmet needs. MST-188 is a cytoprotective, hemorheologic, anti-inflammatory and anti-thrombotic agent that has potential utility in diseases or conditions characterized by microcirculatory insufficiency (endothelial dysfunction and/or impaired blood flow).
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. More information can be found on the Company's web site at
Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.