PolyMedix Initiates Phase 1B/2 Dose-Ranging Clinical Study With PMX-60056 to Reverse Heparin
April 28, 2010 11:01 UTC
Second heparin-reversal study follows successful pilot efficacy study
RADNOR, Pa.--(BUSINESS WIRE)-- 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/2 dose-ranging clinical study with its anticoagulant reversing agent, PMX-60056. The study is intended to demonstrate the safety and efficacy of PMX-60056 in reversing varying heparin levels, including the highest levels commonly used in surgical settings. Results from this Phase 1B/2 study are expected by the end of the second quarter of 2010.
“We are very excited to be continuing the development of PMX-60056 with this fourth clinical study,” commented Nicholas Landekic, President and C.E.O. of PolyMedix. “This study will allow us to observe the effects of PMX-60056 with higher doses of heparin than used in the first pilot efficacy study. In addition, we hope to specifically quantify the doses of PMX-60056 needed to reverse the heparin levels commonly used in cardiothoracic surgery. We are very proud to have discovered this unique anticoagulant reversing agent, and to be the only company developing this type of drug.”
The Phase 1B/2 open label, dose escalation study will enroll up to sixteen healthy subjects into two cohorts. The amount of heparin and PMX-60056 will vary between the two cohorts. Initially, subjects will receive heparin followed by a 10-minute infusion of PMX-60056. Following successful administration and observation of the subjects, a second dose of heparin and PMX-60056 will be administered. This second administration of both heparin and PMX-60056 is intended to evaluate if subjects can, if necessary, be anticoagulated again following heparin reversal with PMX-60056.
In October 2009 PolyMedix successfully completed a Phase 1B proof of concept clinical study with PMX-60056 in healthy subjects. The study results showed that a single dose of PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting with no serious adverse events reported. On March 18, 2010 PolyMedix announced the initiation of a pilot efficacy clinical study with PMX-60056 to evaluate safety and efficacy in the reversal of the Low Molecular Weight Heparin (LMWH) tinzaparin. This study is ongoing with results also expected by the end of the second quarter of 2010.
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). 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. 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. 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. |
