PolyMedix Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, today announced it has commenced a phase II clinical trial to assess the safety and efficacy of its anticoagulant PMX -60056 to reverse post-operative bleeding (heparin) in patients undergoing Percutaneous Coronary Intervention (PCI) procedures.
The clinical study follows conclusion of a review by the United States Food and Drug Administration (FDA) of a protocol submitted by PolyMedix to evaluate PMX-60056 by intravenous infusion. The study is expected to be available at the end of the year, and the company said the results are intended to support further development of PMX-60056.
The anticoagulant heparin is often used to prevent life-threatening blood clots which may occur after surgery. Patients in need of heparin reversal are currently administered the only agent approved to reverse the action of heparin, protamine. However, protamine can have side effects, including bleeding complications and allergic reactions.
“The need for a safer alternative for managing anticoagulation reversal is well understood within the medical community,” Nicholas Landekic, president and CEO of PolyMedix stated in the press release. “To date, we have successfully completed four clinical trials, including three phase IB/II 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.”
For more information visit www.polymedix.com