PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has initiated a Phase 2 clinical trial, following conclusion of a review by the United States Food and Drug Administration (FDA) of a protocol submitted by PolyMedix, to assess the safety and efficacy of its heptagonist, PMX-60056, in reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures. PMX-60056 is a synthetic, small-molecule designed to reverse the anticoagulation activity of heparin and low molecular weight heparins (LMWH).
“In this study, we plan to assess safety and efficacy in reversing heparin using therapeutically appropriate doses of PMX-60056 in patients undergoing PCI.”
"We are excited to move forward with this Phase 2 clinical trial with PMX-60056 in patients," commented Dr. Bozena Korczak, Senior Vice President of Clinical Development and Chief Development Officer of PolyMedix. "In this study, we plan to assess safety and efficacy in reversing heparin using therapeutically appropriate doses of PMX-60056 in patients undergoing PCI."
This 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. Protamine may have potential drawbacks, including bleeding complications and allergic reactions.
"The need for a safer alternative for managing anticoagulation reversal is well understood within the medical community," commented Nicholas Landekic, President and CEO of PolyMedix. "To date, we have successfully completed four clinical trials, including three Phase 1B/2 studies with efficacy assessments where PMX-60056 safely reversed both heparin and LMWH. We are proud to be developing this unique anticoagulant reversing agent to address these important unmet medical needs."
PolyMedix is exploring and evaluating the opportunities for continued clinical development of PMX-60056 for reversal of LMWHs, including potential discussions with regulatory agencies. LMWHs are prescribed to patients in need of long-term anticoagulation outside the hospital. There is currently no drug approved to reverse LMWHs.
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