To determine the effect of a combination treatment with vepoloxamer and tissue plasminogen activator on infarct volume and functional outcome in a rat model of embolic stroke

ABSTRACT Stroke is one of leading causes of death and disability worldwide with higher prevalence in the aged population and in patients with comorbid conditions such as diabetes mellitus DM Tissue plasminogen activator tPA the only Food and Drug Administration FDA approved treatment is limited in its use to andlt of stroke patients No new treatments have been approved for stroke therapy in twenty years Therefore there is a compelling need to develop new and broader utility therapies for acute ischemic stroke Mast Therapeutics MT is currently testing vepoloxamer a proprietary amphipathic copolymer with rheological and membrane protective properties in clinical trials in man Henry Ford Hospital HFH has conducted preliminary studies using vepoloxamer which demonstrated that vepoloxamer reduces infarct volume and improve neurological function in a rat embolic model of middle cerebral artery occlusion MCAO In this Phase SBIR application MT and HFH will collaborate in a study evaluating the combined use of tPA and vepoloxamer in the rat embolic model of MCAO The specific objective of the study is to determine the feasibility of using vepoloxamer as an adjuvant agent to thrombolytic therapy for acute ischemic stroke The expected outcome of the Phase SBIR is intended to provide rationale for further pursuing a Phase study that will establish the combinationandapos s therapeutic window and investigate the effects of the combination treatment in ischemic stroke in female aged and diabetic animals and in another species i e rabbit embolic stroke model according to the Stroke Therapy Academy Industry Roundtable STAIR recommendations Altogether the Phase and studies are intended to provide compelling performance data supporting the development of vepoloxamer as new drug modality for use in stroke PROJECT NARRATIVE The proposed project is consistent with the National Institute of Health s mission to NIH s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health lengthen life and reduce the burdens of illness and disability The grant seeks to improve the therapeutic alternatives available for the treatment of acute ischemic stroke