PolyMedix Initiates Phase 1B/2 Dose-Response Clinical Trial to Reverse the Anticoagulant Activity of Enoxaparin with PMX-60056
PolyMedix, Inc. (OTCBB:PYMX.OB - News), 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(R)), 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.
About PMX-60056
PMX-60056 is a synthetic, small-molecule designed to modulate coagulation and mitigate bleeding in certain interventional cardiology procedures, such as Percutaneous Coronary Intervention (PCI), and emergency situations. PMX-60056 reverses heparin and its derivative, low molecular weight heparin (LMWH), the most common anticoagulants used in the hospital setting. Because bleeding is a side effect that can occur from use of these drugs, the reversal of anticoagulation is expected to reduce the incidence of bleeding complications. PMX-60056 is currently in a Phase 2 clinical trial to assess the safety and efficacy of reversing heparin in patients undergoing Percutaneous Coronary Intervention (PCI) procedures. Prior to initiating the Phase 2 clinical trial, PolyMedix completed three successful Phase 1B/2 trials --- a single dose trial to reverse heparin, a single dose trial to reverse LMWH, and a dose-ranging trial to reverse heparin. In all of these trials, PMX-60056 safely and rapidly reversed the anticoagulant activity of heparin and LMWH.
About PolyMedix, Inc.
PolyMedix is a clinical stage biotechnology company developing first-in-class, small-molecule drugs for the treatment of serious acute care conditions. PolyMedix has a pipeline of novel cardiovascular and infectious disease product candidates, all of which were internally developed using proprietary computational drug design technologies. The lead compound in PolyMedix's cardiovascular program is PMX-60056, which is designed to modulate coagulation and mitigate bleeding in certain interventional cardiology procedures, such as Percutaneous Coronary Intervention (PCI), and emergency situations. PMX-60056 has met safety and efficacy endpoints in four clinical trials conducted to date demonstrating clinical proof of concept. PMX-60056 is currently in a Phase 2 clinical trial in patients undergoing PCI. The lead compound in PolyMedix's infectious disease program is PMX-30063, a new class of antibiotic -- a defensin-mimetic - designed to mimic first-line human innate immunity, or host defense proteins. This innovative approach utilizes the same mechanism of action that evolved in nature which higher life forms use to protect themselves from bacteria. Having the same mechanism of action as the host defense proteins, PMX-30063 is designed to directly address one of the most significant issues in infectious disease today - drug resistance, which is believed to be much less likely to develop with PMX-30063. PMX-30063 is currently in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph aureus bacteria, including methicillin-resistant Staph aureus (MRSA). PolyMedix is also leveraging its antimicrobial expertise with the PolyCides(R), antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces. For more information, please visit our website at www.polymedix.com.
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