SAN DIEGO, May 26, 2015 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company leveraging its molecular adhesion and sealant technology (MAST) platform to develop novel therapies for sickle cell disease, heart failure, and arterial disease, today reported that it has initiated an open-label, multicenter Phase 3 extension study of vepoloxamer (MST-188) in sickle cell disease, referred to as "EPIC-E." The study will enroll patients who have completed the Company's Phase 3 EPIC study and are hospitalized for a subsequent vaso-occlusive crisis.
"We continue to be excited about the potential for vepoloxamer, which is years ahead of other investigational treatments for sickle cell disease," stated Brian M. Culley, Chief Executive Officer. "We have initiated EPIC-E consistent with our prior guidance and plan to make this extension study available at almost all of our more than 70 EPIC sites."
"We believe data from EPIC-E will enhance the quality of a New Drug Application for vepoloxamer in this rare disease, as well as contribute to enthusiasm for the EPIC study," stated Dr. Edwin L. Parsley, Chief Medical Officer. "In particular, for patients who may be hesitant to participate in EPIC because they may be randomly assigned to receive the placebo control, EPIC-E can provide the certainty of receiving vepoloxamer for subsequent crises. EPIC-E also will give study investigators experience administering vepoloxamer to sickle cell patients in an unblinded manner, which we expect will provide valuable feedback for us," continued Dr. Parsley.
About the EPIC-E Study
EPIC-E is an open-label, multicenter Phase 3 extension study in sickle cell disease that will assess the safety and tolerability of repeat administration of vepoloxamer to sickle cell patients who have completed the EPIC study and subsequently are hospitalized for a vaso-occlusive crisis. Secondary objectives are to assess the rate of re-hospitalization for recurrence of vaso-occlusive crisis and the occurrence of acute chest syndrome, a severe and sometimes fatal complication of sickle cell disease. The study is expected to remain open for approximately one year.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging its MAST platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes. The Company is also developing AIR001, a sodium nitrite solution for inhalation via nebulizer, for the treatment of heart failure with preserved ejection fraction (HFpEF).
Vepoloxamer is an investigational drug that, in addition to EPIC and EPIC-E, is being tested in a Phase 2 study to evaluate whether it improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also plans to initiate a Phase 2 study of vepoloxamer in chronic heart failure in the third quarter of this year. AIR001 is an investigational drug being tested in multiple institution-sponsored Phase 2a studies in patients with HFpEF. 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 prospects for successful development and commercialization of the Company's product candidates, including vepoloxamer in sickle cell disease, heart failure and stroke, and anticipated timing of achievement of development milestones, including commencement and completion of clinical and nonclinical 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 the Company's product candidates and the risk that its product candidates, including vepoloxamer, 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 additional nonclinical or clinical studies to be required prior to initiation of a planned clinical study; 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 potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; 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 its product candidates, including clinical studies, manufacturing, and regulatory activities for its product candidates, 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 its product candidates 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 a product candidate in one or more indications, it may not realize commercial success and may never achieve profitability; the risk that the Company is not able to adequately protect its intellectual property rights and prevent competitors from duplicating or developing equivalent versions of its product candidates or that the use or manufacture of its products or product candidates infringe the proprietary rights of others; 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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SOURCE Mast Therapeutics
Mast Therapeutics, Ioana C. Hone, ir@mastthera.com, 858-552-0866 Ext. 303
