>>> PolyMedix Initiates Phase 1B Clinical Study With PMX-60056 To Reverse Low Molecular Weight Heparin PMX-60056 is the first ever agent taken into clinical trials for LMWH reversal
PolyMedix, Inc..Press Release Source: PolyMedix, Inc. On Thursday March 18, 2010, 11:13 am EDT
RADNOR, Pa.--(BUSINESS WIRE)--PolyMedix, Inc. (OTC BB: PYMX - News), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B clinical study to evaluate the safety and efficacy of PMX-60056 in reversing the anticoagulant activity of low molecule weight heparin (LMWH). In a previously conducted Phase 1B, PMX-60056 demonstrated safety and efficacy in reversing heparin in healthy subjects. PMX-60056, one of PolyMedix’s lead compounds, is designed as a small synthetic molecule to reverse heparin-induced anticoagulation.
The Phase 1B double-blind, crossover study will be conducted at a single site in the United States. Up to six healthy subjects will be randomized into two cohorts. All subjects will receive tinzaparin, an FDA approved LMWH, followed by two ten-minute infusions of either PMX-60056 or placebo. With the crossover design, on the second treatment day, each subject will receive the alternate treatment, therefore, those that received PMX-60056 will receive placebo and vice versa. Thus, each subject will serve as their own control. The objective of the study is primarily to assess the safety of using PMX-60056 in subjects that have received LMWH, and will also measure the ability of PMX-60056 to neutralize LMWH and normalize blood clotting time. The results from this Phase 1B study are expected at the end of the 2nd quarter 2010.
LMWHs are widely used to prevent the formation of blood clots in patients with deep vein thrombosis, receiving cancer treatment drugs, or after hip replacement surgeries and heart attacks. Despite the benefits of LMWHs, up to 20% of patients may experience bleeding complications during therapy. With no FDA approved product available to reverse the anticoagulant activity of LMWHs, many of these patients may require life-saving surgery or blood transfusions to treat their bleeding complications.
“We believe bleeding complications associated with LMWHs represent a major unmet medical need for a LMWH reversing agent,” commented Nicholas Landekic, President & C.E.O. of PolyMedix. “There is no approved reversing agent for LMWH. We believe that PMX-60056 is unique in being the first and only LMWH reversing agent in development. This study will help us determine if PMX-60056 has the potential to offer important benefits and improvements in treating these patients at risk of bleeding complications, and may be the first drug developed for this important use.”
LMWHs, like heparin, contain pentasaccharide, a chemical sequence that is essential for their anticoagulation activity. The pentasaccharide in LMWH and heparin binds with antithrombin, which then turns off the normal blood clotting process. PMX-60056 reverses the anticoagulation activity by binding to the pentasaccharide sequence on both heparin and LMWH and disrupting the interaction with antithrombin. As a result, normal blood clotting ability is restored.
In October 2009, PolyMedix successfully completed a similarly designed study in healthy subjects that had received heparin and PMX-60056. The results demonstrated that a single dose of PMX-60056 was well tolerated, and completely and rapidly reversed heparin and normalized blood clotting time in this study.
About PMX-60056
PolyMedix’s heptagonist compound, PMX-60056, is a synthetic, small molecule that reverses the anticoagulant activity of both heparin and low molecular weight heparins (LMWHs). 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 reversing agent available to reverse the anticoagulant activity of LMWHs. Heparin is an i.v. anticoagulant used to prevent clots from forming during certain cardiothoracic and orthopedic surgical procedures. After these procedures, the anticoagulant activity of heparin must be reversed in order to restore normal clot formation. Protamine is presently the only agent available for this use. Protamine has many limitations, and there is a major need for a safer and easier to use heparin reversing agent. PMX-60056 pre-clinical and clinical data suggest many potential safety and other advantages over protamine, as well as a unique opportunity as the first reversing agent for LMWHs.
About PolyMedix, Inc.
PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs and biomaterials for the treatment of acute cardiovascular disorders and infectious diseases. PolyMedix’s compounds are based on biomimetics: non-peptide small molecule drug candidates and polymers that mimic the activity of proteins. PMX-60056, PolyMedix’s heptagonist compound, is being developed to reverse the activity of both heparin and low molecular weight heparins. PolyMedix plans to develop an antagonist drug that is safer and easier to use than currently approved therapy. PMX-30063, PolyMedix’s antibiotic compound is a small molecule that mimics human host-defense proteins and has a completely different mechanism of action distinct from those of current antibiotic drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. PolyMedix’s goal is to develop this compound as a rapidly acting antibiotic for serious systemic and local infections. Both PMX-60056 heptagonist and PMX-30063 antibiotic are currently undergoing clinical testing. PolyMedix also plans to continue the development of polymeric formulations as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit PolyMedix on its website at http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.polymedix.com%2F&esheet=6219579&lan=en_US&anchor=www.polymedix.com&index=1&md5=81c916f3255f93579d6b5bdc42f7eca9.
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