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.