- Repeat administration of vepoloxamer in animals with severe heart failure elicited progressively sustained improvement in left ventricle systolic function evident for at least 6 weeks
- Results support development of vepoloxamer for the treatment of acute and chronic heart failure
SAN DIEGO, Nov. 9, 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 stroke, today announced that data from a nonclinical study of vepoloxamer, its lead product candidate, will be presented at the American Heart Association's (AHA) Scientific Sessions 2015. The poster will be presented by Dr. Hani N. Sabbah, Professor of Medicine and Director of Cardiovascular Research at Henry Ford Health System, at 2:00 p.m. ET today. The AHA conference is being held at the Orange County Convention Center in Orlando, Florida, November 7 through November 11, 2015.
The study evaluated the effects of repeat intravenous 2-hour administrations of vepoloxamer on left ventricle (LV) function in an animal model of microembolization-induced heart failure. Animals were randomized to receive vepoloxamer or placebo (saline) and each received 2 infusions of vepoloxamer or saline control administered 3 weeks apart. The animals were followed for an additional 3 weeks after the second infusion (total follow-up 6 weeks). LV end-diastolic volume (EDV) and end-systolic volume (ESV), LV ejection fraction, and plasma n-terminal-pro brain natriuretic peptide (NT-proBNP) were measured at baseline, at end of first infusion (2 hours), and at 24 hours, 1, 2 and 3 weeks thereafter and then again at 24 hours, 1, 2 and 3 weeks after the second infusion.
Saline infusions had no effect on any of the examined functional measures. Compared to saline, vepoloxamer reduced LV ESV and NT-proBNP and increased LV ejection fraction without affecting LV EDV, heart rate or mean aortic pressure. These benefits were sustained for at least 2 weeks after the first infusion of vepoloxamer and up to 3 additional weeks after the second infusion of vepoloxamer. The results suggest that therapy with repeat intravenous 2-hour infusions of vepoloxamer, pulsed at 3-week intervals, elicits progressively sustained improvement in LV systolic function evident for at least 6 weeks. Furthermore, these results support development of vepoloxamer for the treatment of acute heart failure and potentially for continued therapy post-hospital discharge for chronic heart failure.
Dr. Sabbah said: "The finding that repeat administration of vepoloxamer elicits progressive improvement in LV function in the absence of a hemodynamic effects is important as it suggests vepoloxamer is salvaging damaged myocytes. While additional studies are needed to verify this observation, the results are very promising and suggest significant potential to improve treatment for both acute and chronic HF patients."
Dr. R. Martin Emanuele, the Company's Senior Vice President, Development, said: "We believe the activity of vepoloxamer is very different from existing therapies and may offer a new approach to treating heart failure by directly improving heart function. Also, because of its unique mechanism, vepoloxamer should be additive to existing therapies. We look forward to further demonstrating vepoloxamer's potential in our Phase 2 clinical trial in chronic heart failure patients, which we initiated last month."
Poster Information:
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 (also known as 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 new drug 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 for the treatment of patients with chronic heart failure. AIR001 is an investigational new drug being tested in two 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 may 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 achievement of development milestones, such as commencement and completion of clinical studies or regulatory activities, and of announcement of study data. 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 and the Phase 2 study of vepoloxamer in chronic heart failure; 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 risk that, even if planned 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 potential for additional nonclinical or clinical studies to be required prior to initiation of a planned clinical study; 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 risk that the Company may be required to repay its outstanding debt obligations at a time that could be detrimental to its financial condition, operations and/or business strategy; 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, through patents or otherwise, 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, Inc.
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