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. About PMX-60056 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.
About PolyMedix, Inc.PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs for the treatment of serious infectious diseases and acute cardiovascular disorders. PolyMedix uses a rational drug design approach to create non-peptide, small-molecule drug candidates. PolyMedix’s lead antibiotic compound, PMX-30063, is currently in a Phase 2 clinical trial for treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph, including MRSA. PMX-30063 is a small-molecule that mimics the mechanism of action of human host defense proteins, a mechanism that is distinct from currently approved antibiotic drugs and is intended to make bacterial resistance unlikely to develop. PolyMedix’s lead heptagonist compound, PMX-60056, is in a Phase 2 clinical trial in patients undergoing PCI procedures. PMX-60056 is designed to reverse the anticoagulant activity of both heparin and low molecular weight heparins (LMWH). PolyMedix believes that PMX-60056 could potentially be a safer and easier to use anticoagulant reversing agent, with broader activity, than the currently approved therapy for reversing heparin and LMWH. In addition to its small molecule therapeutics, PolyMedix has polymeric formulations with the same mechanism of action as PMX-30063, PolyCides ®. PolyCides are intended for use in antimicrobial biomaterials applications as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit our website at www.polymedix.com. This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development, and the fact that PolyMedix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.