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SOURCE Mast Therapeutics, Inc.
- 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.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements that are based on the Company's current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to progress with and completion and potential success of the EPIC study, prospects for MST-188 in sickle cell disease, and the Company's development plans for MST-188 in heart failure and acute limb ischemia, including the timing of initiation of any clinical studies. Among the factors that could cause or contribute to material differences between the Company's actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: the uncertainty of outcomes in ongoing and future studies of MST-188 and the risk that MST-188 may not demonstrate adequate safety, efficacy or tolerability in one or more such studies, including EPIC; delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a "clinical hold," and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; the potential for institutional review boards or the FDA or other regulatory agencies to require additional nonclinical or clinical studies prior to initiation of any planned phase 2 clinical study of MST-188; the potential that, even if clinical studies of MST-188 in one indication are successful, clinical studies in another indication may not be successful; the risk that, even if clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the Company's reliance on contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties to assist in the conduct of important aspects of development of MST-188, including clinical studies, and regulatory activities for MST-188, and that such third parties may fail to perform as expected; the Company's ability to obtain additional funding on a timely basis or on acceptable terms, or at all; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, partner MST-188 at inopportune times or pursue less expensive but higher-risk and/or lower return development paths if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops MST-188 in one or more indications, it may not realize commercial success with its products and may never generate revenue sufficient to achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights relating to the MAST platform and MST-188 and prevent competitors from duplicating or developing equivalent versions of its product candidates, including MST-188; and other risks and uncertainties more fully described in the Company's press releases and periodic filings with the Securities and Exchange Commission. The Company's public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
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