Phase IIB: Percutaneous deliverable biomaterial for treating myocardial infarction

DESCRIPTION provided by applicant Heart failure following a myocardial infarction MI continues to remain a leading killer in the western world In the United States the estimated annual incidence of myocardial infarction MI is new and recurrent episodes There is a critical need to develop new therapies since end stage heart failure is only treated through heart transplantation or left ventricular LV assist devices and current pharmaceutical regimens do not adequately prevent post MI negative LV remodeling As an alternative to total heart transplantation cellular cardiomyoplasty or cell transplantation has been explored for the treatment of MI and heart failure however more recently acellular biomaterials have shown great promise in providing similar functional benefit without the complications associated with cell delivery Biomaterial products have the key advantages of being off the shelf available and relatively inexpensive to manufacture Existing materials have however been limited since none have been specifically designed for the myocardium and none mimic the degraded post MI extracellular matrix ECM they are intended to replace The materials suffer from their inability to be delivered via current catheter technology and or their lack of complex myocardial specific ECM cues which promote repair The material used for the Ventrix product is the first example of a myocardial specific material that can be delivered via catheter to promote repair in the post MI environment This material is liquid at room temperature and forms a porous and fibrous scaffold upon injection into the myocardium We have shown that it promotes cell influx increases areas of surviving cardiomyocytes and preserves LV geometry and cardiac function in a rat MI model and can be delivered through a transendocardial catheter approach in a porcine model In our Phase I and II SBIRs we demonstrated that VentriGelTM increased cardiac muscle improved cardiac function and prevented negative LV remodeling in a porcine MI model We also determined a safe dose confirmed safety of the transendocardial approach and performed extensive toxicology and biocompatibility studies In the new Phase IIB SBIR proposal we will initiate studying VentriGelTM in patients which is a key step in bringing a biomaterial product to market which will be complementary or mostly parallel to the current MI pharmaceutical market In our Phase IIB SBIR we will complete a Phase I clinical trial to test the safety and feasibility of delivering VentriGel via a percutaneou transendocardial approach in patients post ST elevation MI PUBLIC HEALTH RELEVANCE The development of therapies to prevent heart failure following a myocardial infarction is a necessity because of the large patient population This proposal seeks to translate a novel catheter deliverable biomaterial therapy for treating myocardial infarction End of Abstract