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Mast Therapeutics Provides Enrollment Update On Phase 3

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mlkrborn   Monday, 01/13/14 04:47:48 PM
Re: mlkrborn post# 11119
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Mast Therapeutics Provides Enrollment Update On Phase 3 "EPIC" Study Of MST-188
- Enrollment on-track at 6 months with 40 U.S. sites open in 2013 - First ex-U.S. sites to open Q1 2014 - Enrollment completion remains on target for YE 2015

SAN DIEGO, Jan. 8, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX) today provided an update on the status of EPIC, its pivotal phase 3 study of MST-188 in sickle cell disease. Consistent with prior guidance, the Company announced that 40 clinical sites were opened in the U.S. by year-end 2013. In addition, clinical sites are expected to open in at least three countries outside the U.S. in the first quarter of 2014, leading to a total of approximately 30 ex-U.S. sites open by the end of 2014. Overall study enrollment is consistent with internal projections and the Company affirmed prior guidance that it expects to complete full enrollment for the trial by the end of 2015.

"We are pleased to see early enrollment for EPIC proceeding in line with our projections," said Brian M. Culley, Chief Executive Officer of Mast Therapeutics. "With enrollment on track and over $44 million on our balance sheet to begin 2014, we continue to see MST-188 as well-positioned to become the first drug to treat an ongoing vaso-occlusive crisis in patients with sickle cell disease. Considering the limited number of comprehensive sickle cell centers with the infrastructure to conduct a clinical study, we believe our ability to rapidly establish EPIC at 40 sites reflects strong interest in the study among physicians who treat these patients."

Based in part on physician enthusiasm for the study and the identification of otherwise eligible adult patient candidates, Mast has decided to amend the study's entry criteria to expand the genotype and age range. In parallel, the Company will add a limited number of adult centers to the 40 pediatric-focused sites that already are open to generate additional safety and efficacy data on MST-188 in the adult population. This decision was made following a determination by disease experts and the EPIC steering committee that expansion will not compromise the ability to enroll a sufficiently homogenous patient population and conduct a successful study. Given that most of the study investigators will be pediatric hematologists, the Company expects the majority of enrolled subjects will be children and young adults.

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 early 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 www.masttherapeutics.com. (Twitter: @MastThera)

Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.

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