PolyMedic, Inc. (OTCBB: PYMX) $85M (MarketCap) Successfully Completes Phase 1B Clinical Study
PolyMedix, Inc. (OTCBB: PYMX) is an emerging biotechnology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious illnesses. Nowadays, it announced its profitable completion of a second Phase 1B clinical safety and pilot efficacy study with PMX-60056, a small synthetic molecule created to reverse the anticoagulant activity of each Heparin and Low Molecular Weight Heparin (LMWH). The data from this study show that PMX-60056 met the study safety and efficacy endpoints relating to the reversal of the anticoagulant activity of the LMWH tinzaparin.
Low Molecular Weight Heparins are employed in roughly 12 million patients annually for chronic treatment of thrombosis. Up to 20% of patients may possibly expertise bleeding complications. With no present FDA approved item available to reverse the anticoagulant activity of LMWHs, numerous of these patients may call for life-saving surgery or blood transfusions to treat their bleeding complications. Herapin is an i.v. anticoagulant utilized to stop clots from forming throughout particular cardiothoracic and orthopedic surgical procedures. Soon after these procedures, the anticoagulant activity of heparin ought to be reversed in order to restore typical clot formation. There is a key want 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 recommend several prospective safety and other benefits over promatine, as nicely as a potentially special chance to be the very first reversing agent for LMWHs.
Highlights from the Phase 1B clinical study consist of:
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 therapy of approximately 12 million patients annually, LMWH products have total annual sales of over billion. This opens up a wide window of profitability for PolyMedix with the successful completion of its PMX-60056 item.
“We believe bleeding complications associated with LMWHs represent a key unmet medical need to have for a new reversing agent,” commented Nicholas Landekic, President & C.E.O. of PolyMedix. “There is no approved reversing agent for LMWH. We think that PMX-60056 is unique in getting the very 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 prospective to supply essential advantages and improvements in treating these patients at risk of bleeding complications.”
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