Mast Therapeutics Announces International Expansion of Phase III ‘EPIC’ Study

In Press Release by Cameron

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February 25, 2014

Mast Therapeutics, Inc. today announced that, consistent with its prior guidance, it has initiated international enrollment in EPIC, its pivotal phase 3 study of MST-188 in sickle cell disease, with clinical sites now open in multiple foreign jurisdictions with high rates of hospitalization for sickle cell disease.  The Company previously reported that it had met its goal of having 40 U.S. sites open by the end of 2013 and is on-track to opening an additional 30 sites outside of the U.S. by the end of 2014.

“I congratulate our clinical operations team for continuing to execute our EPIC development plan on schedule and consistent with our announced timelines,” said Brain M. Culley, Chief Executive Officer of Mast Therapeutics.  “I have met with many of our investigators, both within and outside the U.S., and they are enthusiastic about the potential for MST-188 to become the first agent that reduces the duration of vaso-occlusive crisis in patients with sickle cell disease.  We look forward to building on this momentum, opening new sites and completing enrollment by the end of 2015.”

About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, 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.  In the first quarter of 2014, the Company plans to initiate a phase 2, clinical proof of concept study in acute limb ischemia that will evaluate whether MST-188 improves the effectiveness of existing thrombolytic agents.  The Company also is evaluating development options in heart failure.  More information can be found on the Company’s web site at  (Twitter:@MastThera)

See the full press release here.