PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, announced today that data from its Phase 1B/2 dose ranging clinical study with PMX-60056 was presented at the American Society of Hematology (ASH) 52 nd Annual Meeting. At the same meeting, pre-clinical data on other heptagonist compounds were also presented. PMX-60056 is a synthetic, small-molecule designed to reverse the anticoagulant activity of both heparin and low molecule weight heparin (LMWH). In a poster presentation titled, Reversal of Heparin by Novel Synthetic Antagonist PMX-60056 Exhibits A Linear Dose Response Relationship, Dr. Eric McAllister, Vice President of Clinical Development at PolyMedix, reported clinical results demonstrating that, using measurements routinely available during cardiac surgery, clinicians can accurately predict a single reversing dose of PMX-60056 that will safely and effectively neutralize the anticoagulation effects of heparin. The study examined the dose-response, efficacy, and safety of PMX-60056 in reversing higher doses of heparin, including a dose routinely used in cardiac surgery, and also established that subsequent repeat anticoagulation with heparin was not inhibited by PMX-60056. At the same meeting, Dr. Richard Scott, Vice President of Research at PolyMedix, presented two additional pre-clinical studies as oral and poster presentations. These presentations were: Optimized Fully-Synthetic Salicylamide Heparin Antagonists Have Greater Efficacy Versus LMWHs and Display Improved Hemodynamic Responses as Compared to Protamine, and Arylamides: Discovery of a Novel Class of Fully Synthetic Small Molecule Heparin and LMWH Antagonists. These presentations covered data for certain pre-clinical Salicylamide and Arylamide heptagonist compounds. Compounds from both classes were shown to neutralize fondaparinux and have limited hemodynamic responses. Posters presented are available on the PolyMedix website at: http://www.polymedix.com/presentations.php. 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 there is 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. 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 Phase 2 clinical trials. 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 plans to develop this compound for serious systemic Staphylococcal infections, including methicillin resistant Staphylococcus aureus (MRSA). PolyMedix’s lead heptagonist compound, PMX-60056, has completed Phase 1 testing and is being developed 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.