SAN DIEGO, Dec. 9, 2014 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today provided details of its plan to develop vepoloxamer (MST-188), its lead product candidate, in heart failure.
Consistent with prior guidance, earlier this year, Mast Therapeutics submitted an Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA), together with the protocol for a Phase 2 clinical study in patients hospitalized for acute decompensated heart failure. FDA has completed its 30-day safety review and informed the Company that it may proceed with its proposed clinical study. The Company is finalizing the study protocol and expects to begin recruiting patients in the Phase 2 study in the first half of 2015.
Brian M. Culley, Chief Executive Officer, said: "Since we first announced data from our nonclinical proof-of-concept study in the first quarter, vepoloxamer data has been presented at meetings of the European Society of Cardiology, the Heart Failure Society of America and the American Heart Association. Interest from the leading medical conferences and thought leaders in this field reflects the potentially novel way that vepoloxamer may improve heart failure. We believe its membrane-sealing activity helps restore damaged cardiac cell membranes, thus minimizing calcium overload injury, preserving cardiomyocytes and directly improving heart contractility and function. In contrast to most approved drugs, which have not been shown to improve long-term outcomes, by salvaging cardiac tissue, vepoloxamer may have the potential to reduce the high rates of near-term hospital readmission and mortality associated with heart failure hospitalization."
Mr. Culley continued: "Our planned study will evaluate the safety and efficacy of multiple doses of vepoloxamer in patients hospitalized for acute decompensated heart failure, including its effect on markers of cardiac injury (troponin) and wall stress (NT-proBNP), as well as clinical outcomes. As demonstrated by our rapid progress in this area of significant unmet medical need, we continue to identify new ways to create additional value from our vepoloxamer franchise."
About Heart Failure
Heart failure is a chronic, progressive condition in which heart muscle is unable to pump sufficient blood to meet the body's needs. It is estimated that more than 20 million worldwide, including five to six million in the U.S., suffer from heart failure, which is the most common diagnosis for hospital admission in the U.S. for patients over age 65. The American Heart Association estimates that total medical costs of heart failure in the U.S. will increase from approximately $21 billion in 2012 to approximately $53 billion in 2030, with the majority (80%) of such costs related to hospitalization.
In March 2014, the Company announced that the United States Adopted Names (USAN) Council assigned "vepoloxamer" as the unique non-proprietary (generic) name for the active pharmaceutical ingredient (API) in MST-188. The Company sought a unique name for its API to clearly identify it as different from non-purified poloxamers. In support of its application, the Company submitted proprietary data showing that drug products containing non-purified poloxamers may have serious toxicity consequences and should not be substituted for or confused with MST-188.
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 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 enrolling subjects in EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and in a Phase 2 study to evaluate whether vepoloxamer improves the effectiveness of recombinant tissue plasminogen activator therapy in patients with acute limb ischemia. The Company also is planning to initiate a Phase 2 study of vepoloxamer in patients with acute decompensated heart failure in the first half of 2015. 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 of the Company's product candidates, including vepoloxamer in heart failure, and anticipated timing of achievement of development milestones, including commencement of a Phase 2 study of vepoloxamer in heart failure. 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; 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 a planned clinical study of a product candidate; 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 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 vepoloxamer or AIR001 and prevent competitors from duplicating or developing equivalent versions of its product candidates; 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, Inc.
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