SAN DIEGO, March 23, 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, arterial disease and heart failure, today announced its plans to develop vepoloxamer (MST-188) for the treatment of patients with chronic heart failure. Encouraged by recently reported nonclinical results and input from experts in the field, the Company expects to begin dosing in a Phase 2 study of vepoloxamer in patients with chronic heart failure in the third quarter of this year.
Wilson S. Colucci M.D., Professor of Medicine and Physiology and Chief of Cardiovascular Medicine at Boston University School of Medicine said: "The results from studies in experimental heart failure are encouraging and support clinical testing in patients with chronic heart failure. If shown to translate to patients with clinical heart failure, vepoloxamer may offer a way of directly improving LV contractile function by restoring cardiomyocyte membrane integrity and increasing their survival. Such a novel mechanism offers great potential for our patients."
Brian M. Culley, Chief Executive Officer of the Company, said: "While we are still in the planning process, we expect the Phase 2 study will be a randomized, double-blind, two-arm, placebo-controlled study of the safety and efficacy of a single administration of vepoloxamer in patients with chronic heart failure, including its effect on markers of cardiac injury (troponin) and wall stress (NT-proBNP), as well as clinical outcomes. We anticipate that the study will be conducted on an outpatient basis and enroll approximately 150 patients at sites in and outside of the U.S. Of note, we recently filed new patent applications claiming the use of vepoloxamer in this and other clinical settings of heart failure and will continue to identify ways to create additional value and protect the sizeable market opportunity of our vepoloxamer pipeline."
The Company previously reported results from two randomized, placebo-controlled nonclinical studies of vepoloxamer in a model of chronic, stable heart failure produced by intracoronary microembolizations. In the first study, as reported last year, a single, two-hour administration of vepoloxamer resulted in robust improvements in key parameters of heart function, including left ventricular (LV) end-systolic volume, ejection fraction, stroke volume and cardiac output, which persisted for one to two weeks. In the second study, vepoloxamer was administered at the start of the study and a repeat treatment was administered three weeks after the first. The study concluded after a total of six weeks. As the Company reported earlier this month, the second study not only reproduced the treatment effect of the first study, but also showed that retreatment with vepoloxamer at three weeks after the initial administration improved upon the effects observed after the first administration. The effects observed after the second administration persisted for at least three weeks, until 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 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.
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.
About Vepoloxamer
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 also developing AIR001, a sodium nitrite solution for inhalation via nebulizer, for the treatment of heart failure with preserved ejection fraction (HFpEF).
Vepoloxamer is being tested in a pivotal Phase 3 study called EPIC for the treatment of vaso-occlusive crisis in patients with 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 plans to initiate a Phase 2 study of vepoloxamer in chronic heart failure in the third quarter of this year. AIR001 is 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 of vepoloxamer as a treatment for heart failure patients, anticipated timing of commencement of a Phase 2 study of vepoloxamer in heart failure, and the Company's ability to protect its intellectual property rights, including through obtaining patents covering its product candidates and their uses. 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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SOURCE Mast Therapeutics, Inc.
Mast Therapeutics, Ioana C. Hone (ir@mastthera.com), 858-552-0866 Ext. 303
