PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced that clinical data with PMX-60056 were presented at the American Heart Association’s Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB) Meeting in Chicago on April 28, 2011. PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulation activity of heparin and low molecular weight heparins (LMWH).
In a poster presentation, Dr. Eric McAllister, Vice President of Cardiovascular Clinical Development at PolyMedix, reported an analysis of data from two separate Phase 1B/2 clinical studies with PMX-60056 to reverse two different anticoagulants, heparin and LMWH (tinzaparin). PolyMedix designed PMX-60056 to interact with a specific chemical group on the heparin and LMWH molecules called pentasaccharide. Observational data suggests that both heparin and tinzaparin appear to bind on a one-to-one molecular basis with PMX-60056. These data suggest that dosing may be simplified for future clinical studies.
“Based on this preliminary analysis, it appears that each molecule of PMX-60056 binds with exactly one heparin or LMWH molecule,” commented Dr. McAllister. “Not only should this make it easier to predict the correct dose for each patient, but it also supports our observation that PMX-60056 binds irreversibly to heparin and LMWH, and that only an excess of unbound PMX-60056 appears to contribute to any transient hypotension. These data will be helpful to identify precise dosing requirements as we design future clinical studies with PMX-60056.”
PMX-60056 is currently in a Phase 2 clinical trial to assess the safety and efficacy of reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures.
PolyMedix’s heptagonist compound, PMX-60056, is a synthetic, small-molecule designed to reverse the anticoagulant activity of both heparin and low molecular weight heparins (LMWHs). Heparin is an intravenous anticoagulant used to prevent clots from forming during certain cardiothoracic and orthopedic surgical procedures. After these procedures, the anticoagulant activity of heparin is reversed in order to prevent post-operative bleeding. Protamine is presently the only agent available for this use. Protamine has many limitations, and we believe represents a major need for alternative heparin reversing agents which may be safer or easier to use. LMWHs are used in approximately 12 million patients annually for chronic treatment of thrombosis. Up to 20% of patients may experience bleeding complications. There is presently no FDA approved agent available to reverse the anticoagulant activity of LMWHs, and many of these patients may require life-saving surgery or blood transfusions to treat their bleeding complications. PolyMedix believes PMX-60056 pre-clinical and clinical data suggest potential safety and other advantages over protamine, as well as an opportunity to be the first reversing agent for LMWHs.