PolyMedix Initiates Phase 1B/2 Dose-Response Clinical Trial to Reverse the Anticoagulant Activity of Enoxaparin with PMX-60056
RADNOR, Pa., Sept. 27, 2011 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and life-threatening infectious diseases, has initiated a Phase 1B/2 clinical study to evaluate the safety and efficacy of PMX-60056 in reversing the anticoagulant activity of enoxaparin (Lovenox®), a low molecular weight heparin (LMWH). PMX-60056 is a small-molecule designed to modulate coagulation and mitigate bleeding in certain interventional cardiology procedures and emergency situations. PMX-60056 is also currently in a Phase 2 clinical trial in patients undergoing Percutaneous Coronary Intervention (PCI).
"We are excited to expand the development of PMX-60056 to reverse the most widely used low molecular weight heparin both in the United States and worldwide," said Nicholas Landekic, President and CEO of PolyMedix. "In previously conducted clinical studies, PMX-60056 met the safety and efficacy endpoints in reversing the anticoagulant activity of both unfractionated heparin and the low molecular weight heparin, tinzaparin. We are proud to be developing this novel therapy for coagulation management which is designed to address important unmet medical needs by making interventional cardiology procedures safer."
The open-label, dose-response, Phase 1B/2 study will be conducted at a single site in the United States and enroll up to 18 healthy male and female subjects. All subjects will receive either a subcutaneous injection or intravenous bolus of enoxaparin to determine the anti-Xa dose response to enoxaparin. After the first enoxaparin dose and subsequent wash out period, subjects will receive the same dose and delivery of enoxaparin a second time followed by a single administration of PMX-60056 to reverse a set amount of the anticoagulant effect of enoxaparin. The primary objective of the study is to assess the safety of using PMX-60056 in subjects that have received enoxaparin. PolyMedix also intends to identify the dose-response correlation for PMX-60056 to reverse the anticoagulant activity of enoxaparin, which is expected to guide the dosing of PMX-60056 in potential future clinical trials for reversal of enoxaparin. Results from the trial are expected by the end of this year.
LMWHs are commonly used in non-surgical procedures to prevent blood clots from forming. While anticoagulant therapy has proven pharmacological benefits, the medical challenge is to maintain adequate blood supply by balancing the prevention of blood clot formation while minimizing the risk of bleeding. PolyMedix believes that PMX-60056 offers the potential to advance the management of coagulation in certain surgical and non-surgical procedures and reduce the incidence of bleeding complications. |
