Planning Phase 2 Clinical Trial in Interventional Cardiology
Distinguished Scientists and Clinicians join Heptagonist Clinical Advisory Board
RADNOR, Pa.--(BUSINESS WIRE)-- PolyMedix, Inc. (OTC BB: PYMX), a biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has announced plans for a Phase 2 clinical trial of PMX-60056 in interventional cardiology, and the establishment of a focused Heptagonist Clinical Advisory Board (CAB). PMX-60056 is a synthetic small-molecule designed to reverse the anticoagulant activity of heparin and low molecular weight heparins (LMWH).
PolyMedix recently had an End-of-Phase 1 meeting with the United States Food and Drug Administration (FDA), the primary purpose of which was to seek advice from the FDA on the next steps for the clinical development of PMX-60056. Based on comments received, PolyMedix plans to study PMX-60056 in a Phase 2 clinical trial in Percutaneous Coronary Intervention (PCI) patients instead of next conducting a Phase 2 study in Coronary Artery Bypass Grafts (CABG), and anticipates filing a Phase 2 PCI protocol with the FDA in the upcoming weeks. Commencement of this Phase 2 clinical trial, which may occur as early as later this year or early next year, will depend on a variety of factors, including clearance of the protocol by the FDA, Institutional Review Board approvals at clinical study sites, and other regulatory processes, which can vary in duration. PolyMedix is evaluating the possibilities for additional Phase 2 clinical trials, such as reversal of LMWH, as well as a Phase 2 clinical trial in CABG patients in the future.
“We appreciate the FDA’s comments and value their advice, and are happy to have illumination for the path forward with PMX-60056,” commented Nicholas Landekic, President and CEO of PolyMedix. “We are pleased to be moving forward with plans for a Phase 2 study in patients. We look forward to applying what we have learned regarding the activity of PMX-60056 to now studying patients in the interventional cardiology setting, and to the continued development of PMX-60056 for both reversal of heparin and the low molecular weight heparins.”
PolyMedix has organized a dedicated Heptagonist Clinical Advisory Board (CAB) with a group of distinguished scientific and clinical experts. The CAB will actively advise PolyMedix on the future clinical development of PMX-60056.
The Heptagonist Clinical Advisory Board Members include:
Jawed Fareed, Ph.D.: Professor, Departments of Pathology and Pharmacology, Director of the Special Coagulation Laboratory and the Hemostasis and Thrombosis Research Program at Loyola University. Dr. Fareed’s research work on the pathogenesis of thrombotic disorders focuses on the role of plasmatic, vascular, and cellular mediators of thrombogenesis, in particular the study of tissue factor in the mediation of thrombotic efficacy in such arterial diseases as thrombotic stroke and myocardial infarction.
J. Donald Hill, M.D.: Department of Cardiac Surgery at California Pacific Medical Center. Dr. Hill has expertise in adult and pediatric cardiac surgery and general thoracic surgery. He is a member of several societies including the Cardiothoracic Surgery Network, The Society of Thoracic Surgeons and the American Association for Thoracic Surgery. Dr. Hill has pioneered minimally-invasive cardiac surgery procedures and the development of the prosthetic heart, and has also patented several devices in both fields.
Russell D. Hull, M.B.B.S., MSc: Professor of Medicine for the Departments of Medicine and Community Health Sciences, as well as the Director of the Thrombosis Research Unit at the University of Calgary. His research activities involve large-scale, multi-centre clinical trials which have been responsible for improving clinical practice. Dr. Hull is heavily involved in teaching evidence-based medicine internationally and has received a number of awards and distinctions for his research contributions towards innovative and evidence-based methods of improving care for patients with thrombosis.
Blaine A. Kent, M.D., F.R.C.P.C.: Head of Cardiac Anesthesiology at Dalhousie University and the Director of the Perioperative Blood Management Program at the Capital District Health Authority. Dr. Kent was recently promoted to the rank of Associate Professor and sits on numerous committees related to blood management and transfusion. He has been invited to participate in a number of national and international consensus meetings on perioperative blood management, fluid management, and development of massive transfusion protocols and is actively involved in research in many of these areas. Dr. Kent is active in teaching medical students, residents, staff, and other allied health professionals in the areas of coagulation, bleeding in cardiac surgery, transfusion, fluid management, echocardiography, and cardiac anesthesia.
Jerrold H. Levy, M.D., F.A.H.A.: Professor of Anesthesiology and Deputy Chairman for Research in the Department of Anesthesiology at Emory University School of Medicine. He is also Co-Director of Cardiothoracic Anesthesiology, an Attending Physician in the Cardiothoracic Intensive Care Unit at Emory University Hospital, and serves as consultant to the FDA (CBER). His research interests include hemostasis, acute inflammation and anaphylactic reactions, cardiovascular pharmacology, and vascular physiology.
Jeffrey A. Morgan, M.D.: Cardiothoracic surgeon, Associate Director of Mechanical Circulatory Support (LVAD program) and Heart Transplantation and Director of Cardiac Surgery Research at Henry Ford Hospital. Dr. Morgan has expertise in coronary artery bypass grafting, aortic valve replacement, mitral valve repair/replacement, aortic aneurysm repair, and the surgical treatment of heart failure with cardiac transplantation and left ventricular assist devices (LVADs).
Lilia Talarico, M.D.: Former Medical Officer of the Food and Drug Administration (FDA), former Director of FDA Division of Gastrointestinal and Coagulation Drug products, and former Associate Director of FDA Oncology Division. Prior to joining FDA, Dr. Talarico served as Associate Professor of Medicine and Director of the coagulation laboratory at Boston University Medical Center. She is board certified in internal medicine, hematology and oncology.
Jeffrey Weitz, M.D., F.R.C.P.C., F.A.C.P.: Professor of Medicine and Biochemistry and Biomedical Sciences at McMaster University and Executive Director of the Thrombosis and Atherosclerosis Research Institute. Board certified in internal medicine, hematology and medical oncology, Dr. Weitz now directs a research laboratory that focuses on the biochemistry of blood coagulation and fibrinolysis as it applies to venous and arterial thrombosis.
Jeremy R. Wood, M.D.: Associate Professor of Surgery at Dalhousie University. Dr. Wood has expertise in general surgery, cardiovascular surgery and thoracic surgery. Dr. Wood is a member of several medical societies and has conducted lectures and seminars on hemostasis, aortic dissections, thoracic aortic emergencies, and aneurysms.
“We are honored that these influential thought leaders have agreed to work with us and join our Heptagonist Clinical Advisory Board,” commented Dr. Eric McAllister, Vice President of Clinical Development and Chief Medical Officer at PolyMedix. “We expect their scientific and medical input will be instrumental in guiding the future clinical and regulatory development of our heptagonist, PMX-60056.”
PolyMedix expects to further expand its outside advisory relationships through the organization of a focused Antibiotic Clinical Advisory Board, as well as a Scientific Advisory Board, in the near future.
PolyMedix’s heptagonist compound, PMX-60056, is a synthetic, small-molecule designed to reverse the anticoagulant activity of both heparin and low molecular weight heparins (LMWHs). Heparin is an intravenous anticoagulant used to prevent clots from forming during certain cardiothoracic and orthopedic surgical procedures. After these procedures, the anticoagulant activity of heparin is reversed in order to prevent post-operative bleeding. Protamine is presently the only agent available for this use. Protamine has many limitations, and we believe there is a major need for alternative heparin reversing agents which may be safer or easier to use. LMWHs are used in approximately 12 million patients annually for chronic treatment of thrombosis. Up to 20% of patients may experience bleeding complications. There is presently no FDA approved agent available to reverse the anticoagulant activity of LMWHs. PolyMedix believes PMX-60056 pre-clinical and clinical data suggest potential safety and other advantages over protamine, as well as an opportunity to be the first reversing agent for LMWHs.
About PolyMedix, Inc.
PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs for the treatment of serious infectious diseases and acute cardiovascular disorders. PolyMedix uses a rational drug design approach to create non-peptide small molecule drug candidates. PolyMedix’s lead antibiotic compound, PMX-30063, is currently in Phase 2 clinical trials. PMX-30063 is a small molecule that mimics the mechanism of action of human host defense proteins, a mechanism that is distinct from currently approved antibiotic drugs and is intended to make bacterial resistance unlikely to develop. PolyMedix plans to develop this compound for serious systemic Staphylococcal infections, including methicillin resistant Staphylococcus aureus (MRSA). PolyMedix’s lead heptagonist compound, PMX-60056, has completed Phase 1 testing and is being developed to reverse the anticoagulant activity of both heparin and low molecular weight heparins (LMWH). PolyMedix believes that PMX-60056 could potentially be a safer and easier to use anticoagulant reversing agent, with broader activity, than the currently approved therapy for reversing heparin and LMWH. In addition to its small molecule therapeutics, PolyMedix has polymeric formulations with the same mechanism of action as PMX-30063, PolyCides™, which are intended for use in antimicrobial biomaterials applications s additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit our website at www.polymedix.com.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements, PolyMedix’s compounds may not successfully complete clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
Lisa Caperelli, 484-598-2406
Director, Investor Relations & Corporate Communications
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INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Infectious Diseases Pharmaceutical