SAN DIEGO, March 2, 2015 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today announced preliminary findings from a randomized, placebo-controlled, nonclinical study of vepoloxamer (MST-188) in a model of chronic, stable heart failure produced by intracoronary microembolizations. The primary objective of this study was to examine the effects of repeat intravenous administration of vepoloxamer on left ventricular (LV) systolic and diastolic function.
Consistent with results of a previously reported study, in this study, a single, two-hour administration of vepoloxamer resulted in robust improvements that persisted for 1 - 2 weeks in key parameters of heart function, including LV end-systolic volume, ejection fraction, stroke volume, and cardiac output. Notably, LV ejection fraction was improved by approximately 20% for up to two weeks, returning to baseline values by three weeks post-administration. Diastolic function also was improved. Following a second administration (three weeks after the first), similar improvements in LV systolic and diastolic function were again observed. The effects observed after the second administration persisted for at least three weeks post-administration to the end of the six-week study. Notably, after the second administration, LV ejection fraction had not returned to baseline values by the end of the six-week study, but was still improved by approximately 20% above baseline. Vepoloxamer had no statistically significant effect on heart rate or blood pressure compared to control.
Dr. Hani N. Sabbah, Professor of Medicine & Director of Cardiovascular Research at Henry Ford Health System, said: "The membrane-sealing activity of vepoloxamer may be helping restore damaged cardiac cell membrane integrity, thus minimizing calcium overload injury, preserving cardiomyocytes, and directly improving LV contractile function. These results support clinical testing of pulsed therapy with vepoloxamer in patients with chronic heart failure as well as acute administration in acute heart failure. Therapy with vepoloxamer may be particularly useful in treating heart failure patients after discharge from the hospital following an acute heart failure exacerbation event."
Dr. R. Martin Emanuele, the Company's Senior Vice President, Development, said: "Because vepoloxamer is administered by intravenous injection, we initially believed the clinical utility would be limited to acute heart failure. However, these new findings are supportive of use in chronic heart failure and, in particular, during the period following hospital discharge, which is considered a 'high vulnerability' period for chronic heart failure patients as it is associated with high re-hospitalization and mortality rates, or in patients with continued myocardial injury as evidenced by biomarker testing. In addition, the dose that was used in these nonclinical studies is approximately one-third of the dose that is administered in our ongoing Phase 3 study in sickle cell crisis. Accordingly, we believe this dose will translate well to future clinical studies conducted in heart failure patients."
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 individuals 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.
Vepoloxamer is the unique non-proprietary (generic) name for purified poloxamer 188. The Company sought a unique name to clearly identify its purified poloxamer 188 as different from non-purified poloxamers. In support of its application for vepoloxamer to the United States Adopted Names (USAN) Council, 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 drug products containing vepoloxamer.
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 into EPIC, a pivotal Phase 3 study of vepoloxamer in sickle cell disease, and into 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 heart failure this year. 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 vepoloxamer as a treatment for heart failure patients and anticipated timing of 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 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; 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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