PA Bio Watch
Volume 8 Issue 2
PolyMedix

PolyMedix is a publicly traded biotechnology company focused on developing novel, first of their kind therapeutic drugs to treat infectious diseases and acute cardiovascular disorders. Headquartered in Radnor, PA, PolyMedix was founded in 2002 after obtaining an exclusive license to the computational drug design technology which was created by National Academy of Science members Drs. William DeGrado and Michael Klein at the University of Pennsylvania. This technology was designed to create small molecule compounds that mimic the activity of proteins. With this technology, PolyMedix has developed a robust pipeline of product candidates that meet the company's business model, including, addressing major unmet medical needs, conducting relatively fast and inexpensive clinical trials that demonstrate early clinical proof-of-concept and selecting indications with straightforward clinical endpoints.

To date, PolyMedix has raised over $70 million in capital from the investment community since its inception in 2002. Additionally, PolyMedix has received more than $10 million in support from government funding and research contracts.

The first two lead products in PolyMedix's pipeline are PMX-60056 (heptagonist) and PMX-30063 (novel antibiotic). Both products are entering Phase 2 in 2010.

PMX-60056
PMX-60056, is a synthetic, small molecule designed to restore normal hemostasis (blood clotting) by reversing the anticoagulant activity of unfractionated heparin and Low Molecular Weight Heparins (LMWHs). Currently, the only agent available to reverse heparin is protamine and there is no FDA approved product available to reverse the anticoagulant activity of LMWHs.

Results from a successful Phase 1B pilot efficacy study using PMX-60056 to reverse heparin showed that PMX-60056 completely neutralized heparin and normalized blood clotting time and was well-tolerated with no clinically significant adverse effects. PolyMedix plans to initiate a similar Phase 1B/2 clinical trial in the first quarter of 2010 to evaluate PMX-60056 in reversing LMWHs. In addition, PolyMedix will initiate a Phase 1B/2 dose-ranging study for the reversal of heparin in healthy subjects. Both trials are expected to be completed in the second quarter of 2010. In the third quarter of 2010 PolyMedix plans to conduct a Phase 2 clinical trial in cardiothoracic surgery.

PMX-30063
PolyMedix's antibiotic compound, PMX-30063, is the first of its kind: a small molecule mimetic of human host-defense proteins, imitating one of the oldest and most effective antimicrobial defense systems found in virtually all living creatures. PMX-30063 has unique properties including a mechanism of action that is completely different than current antibiotic drugs, and intended to make bacterial resistance unlikely to develop.

Data from two Phase I clinical studies demonstrate that PMX-30063 is safe and well-tolerated at dose levels which demonstrated antimicrobial activity in the blood of healthy volunteers. PolyMedix plans to complete the third and final segment of the ongoing Phase 1B study with PMX-30063 by the end of the first quarter of 2010, and plans to start a Phase 2 clinical study for the treatment of Staph infections, including MRSA, by the end of the second quarter of this year.

Other Products
PolyMedix has other programs in the pipeline that focus on the development of polymeric formulations of defensin-mimetics as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces.

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