February 10, 2011 – A Phase 2 clinical trial has been initiated to test the safety and efficacy of drug to reverse heparin in patients undergoing percutaneous coronary intervention (PCI). The trial will assess PolyMedix’s heptagonist, PMX-60056, a synthetic small-molecule designed to reverse the anticoagulation activity of heparin and low molecular weight heparins (LMWH).
The multi-center, open-label Phase 2 clinical study is intended to enroll up to 40 patients undergoing PCI in the United States. All patients will receive PMX-60056 by intravenous infusion, in a dose calculated to reduce the post-procedure ACT (activated clotting time) to less than 30 seconds above the baseline level. The primary endpoint of the study is to evaluate the safety and efficacy of PMX-60056 in reversing heparin in a surgical setting. Data collected from this study are intended to support further development of PMX-60056 in larger and more diverse patient populations. The study is expected to be completed by the end of this year.
The anticoagulant heparin is often used in acute surgical applications to prevent life-threatening blood clots. After surgery, patients in need of heparin reversal are administered protamine, which is currently the only agent approved to reverse the action of heparin. However, protamine may have potential drawbacks, including bleeding complications and allergic reactions. Up to 20 percent of patients may experience bleeding complications with protamine.
LMWHs are prescribed to patients in need of long-term anticoagulation outside the hospital. There is currently no drug approved in the United States to reverse LMWHs.
For more information: www.polymedix.com