SAN DIEGO, Feb. 11, 2015 /PRNewswire/ -- Mast Therapeutics, Inc. (NYSE MKT: MSTX), a clinical-stage biopharmaceutical company, today announced that, in a model of embolic stroke with delayed administration of tissue plasminogen activator (tPA), treatment with vepoloxamer (MST-188), both alone and in combination with tPA, was superior to treatment with tPA alone and saline controls. Importantly, treatment with vepoloxamer alone and in combination with tPA did not increase the incidence of hemorrhage.
In the study, tPA or saline control was administered 4 hours after embolic middle cerebral artery occlusion (MCAO). Vepoloxamer in combination with tPA significantly (p<0.05) improved neurological functional outcome and reduced brain tissue loss compared to treatment with tPA alone or saline. Additionally, the combination of vepoloxamer and tPA significantly (p<0.05) reduced fibrin deposition in the microvasculature compared to tPA alone and saline. No significant differences in the incidence of gross hemorrhage were detected among the treatment groups. The study data is being presented during the 2015 International Stroke Conference, currently underway in Nashville.
Brian M. Culley, Chief Executive Officer, said: "These data provide further evidence that vepoloxamer may provide a benefit in diseases where microcirculatory blood flow is impaired. In this study, we sought to demonstrate that vepoloxamer has potential to improve the therapeutic effect of tPA and, importantly, expand the window during which it is effective. We currently are enrolling patients in a Phase 2 study of vepoloxamer in combination with recombinant tPA in patients with acute limb ischemia to assess whether vepoloxamer can accelerate time-to-reperfusion. The results of that trial next year, along with this new data and additional planned studies in stroke models, will help guide our evaluation of the opportunities to develop vepoloxamer in stroke."
The poster entitled "Combination of Vepoloxamer and tPA Extends the Therapeutic Window of Stroke" is being presented by Li Zhang, M.D.1, Michael Chopp, Ph.D.1,2, R. Martin Emanuele, Ph.D.3, et. al. 1Department of Neurology at the Henry Ford Hospital in Detroit, Michigan; 2Department of Physics at Oakland University in Rochester, Michigan; 3Senior Vice President, Development, Mast Therapeutics, Inc.
Stroke is the fourth leading cause of death in the U.S. and over 85% of human strokes are ischemic strokes, meaning they occur when a blood vessel that supplies blood to the brain is blocked by a clot, impairing blood flow to that area. Embolic stroke is a type of ischemic stroke that occurs when a blood clot breaks loose from one place in the blood vessels of the brain, or from some other part of the body, and travels up to the brain blocking or restricting blood flow to the brain. Recombinant tPA is approved for acute ischemic stroke in humans, however, its utilization is limited by its narrow therapeutic window and hemorrhagic complication.
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 heart failure in the second quarter 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 development plans for the Company's product candidates and anticipated development milestones. 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: 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 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; 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 as needed 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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