Second heparin-reversal study follows successful pilot efficacy study
RADNOR, Pa.--(BUSINESS WIRE)-- PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has initiated a Phase 1B/2 dose-ranging clinical study with its anticoagulant reversing agent, PMX-60056. The study is intended to demonstrate the safety and efficacy of PMX-60056 in reversing varying heparin levels, including the highest levels commonly used in surgical settings. Results from this Phase 1B/2 study are expected by the end of the second quarter of 2010.
“We are very excited to be continuing the development of PMX-60056 with this fourth clinical study,” commented Nicholas Landekic, President and C.E.O. of PolyMedix. “This study will allow us to observe the effects of PMX-60056 with higher doses of heparin than used in the first pilot efficacy study. In addition, we hope to specifically quantify the doses of PMX-60056 needed to reverse the heparin levels commonly used in cardiothoracic surgery. We are very proud to have discovered this unique anticoagulant reversing agent, and to be the only company developing this type of drug.”
The Phase 1B/2 open label, dose escalation study will enroll up to sixteen healthy subjects into two cohorts. The amount of heparin and PMX-60056 will vary between the two cohorts. Initially, subjects will receive heparin followed by a 10-minute infusion of PMX-60056. Following successful administration and observation of the subjects, a second dose of heparin and PMX-60056 will be administered. This second administration of both heparin and PMX-60056 is intended to evaluate if subjects can, if necessary, be anticoagulated again following heparin reversal with PMX-60056.
In October 2009 PolyMedix successfully completed a Phase 1B proof of concept clinical study with PMX-60056 in healthy subjects. The study results showed that a single dose of PMX-60056 completely reversed the anticoagulant effects of heparin and normalized blood clotting with no serious adverse events reported. On March 18, 2010 PolyMedix announced the initiation of a pilot efficacy clinical study with PMX-60056 to evaluate safety and efficacy in the reversal of the Low Molecular Weight Heparin (LMWH) tinzaparin. This study is ongoing with results also expected by the end of the second quarter of 2010.
PolyMedix’s heptagonist compound, PMX-60056, is a synthetic, small molecule that reverses the anticoagulant activity of both heparin and low molecular weight heparins (LMWHs). Heparin is an i.v. anticoagulant used to prevent clots from forming during certain cardiothoracic and orthopedic surgical procedures. After these procedures, the anticoagulant activity of heparin must be reversed in order to restore normal clot formation. Protamine is presently the only agent available for this use. Protamine has many limitations, and there is a major need for a safer and easier to use heparin reversing agent. 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. PMX-60056 pre-clinical and clinical data suggest many potential safety and other advantages over protamine, as well as a unique opportunity as the first reversing agent for LMWHs.
About PolyMedix, Inc.
PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs and biomaterials for the treatment of acute cardiovascular disorders and infectious diseases. PolyMedix’s compounds are based on biomimetics: non-peptide small molecule drug candidates and polymers that mimic the activity of proteins. PMX-60056, PolyMedix’s heptagonist compound, is being developed to reverse the activity of both heparin and low molecular weight heparins. PolyMedix plans to develop an antagonist drug that is safer and easier to use than currently approved therapy. PMX-30063, PolyMedix’s antibiotic compound is a small molecule that mimics human host-defense proteins and has a completely different mechanism of action distinct from those of current antibiotic drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. PolyMedix’s goal is to develop this compound as a rapidly acting antibiotic for serious systemic and local infections. Both PMX-60056 heptagonist and PMX-30063 antibiotic are currently undergoing clinical testing. PolyMedix also plans to continue the development of polymeric formulations as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit PolyMedix on its 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 enter or 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
KEYWORDS: United States North America Pennsylvania
INDUSTRY KEYWORDS: Health Biotechnology Cardiology Clinical Trials Infectious Diseases Pharmaceutical General Health