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Mast Therapeutics Provides Enrollment Update On Phase 3 "EPIC" Study Of MST-188
Date:1/8/2014

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 commit
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