PolyMedix, Inc. (OTC BB: PYMX), 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.
“We believe bleeding complications associated with LMWHs represent a major unmet medical need for a LMWH reversing agent”
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.
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