PolyMedic, Inc. (OTCBB: PYMX) $85M (MarketCap)

PolyMedix, Inc. (OTCBB: PYMX) is an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases. Today, it announced its successful completion of a second Phase 1B clinical safety and pilot efficacy study with PMX-60056, a small synthetic molecule designed to reverse the anticoagulant activity of both Heparin and Low Molecular Weight Heparin (LMWH). The data from this study show that PMX-60056 met the study safety and efficacy endpoints regarding the reversal of the anticoagulant activity of the LMWH tinzaparin.

Low Molecular Weight Heparins are used in approximately 12 million patients annually for chronic treatment of thrombosis. Up to 20% of patients may experience bleeding complications. With no current FDA approved product available to reverse the anticoagulant activity of LMWHs, many of these patients may require life-saving surgery or blood transfusions to treat their bleeding complications. Herapin 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. There is a major need for alternative heparin reversing agents that are safer and easier to use, due to the existing Promatine that has many limitations. PMX-60056 pre-clinical and clinical data suggest many potential safety and other advantages over promatine, as well as a potentially unique opportunity to be the first reversing agent for LMWHs.

Highlights from the Phase 1B clinical study include:

• PMX-60056 neutralized the anticoagulant activity of LMWH tinzaparin
• PMX-60056 normalized blood clotting time
• PMX-60056 was safely administered in humans with no serious adverse events occurring in the study
  

With the treatment of approximately 12 million patients annually, LMWH products have total annual sales of over $4 billion. This opens up a wide window of profitability for PolyMedix with the successful completion of its PMX-60056 product.

"We believe bleeding complications associated with LMWHs represent a major unmet medical need for a new reversing agent," commented Nicholas Landekic, President & C.E.O. of PolyMedix. "There is no approved reversing agent for LMWH. We believe that PMX-60056 is unique in being the first and only reversing agent in development designed to reverse the anticoagulant activity of both unfractionated heparin and LMWH. This study has shown that PMX-60056 has the potential to offer important benefits and improvements in treating these patients at risk of bleeding complications."