DSX Therapeutics And R&D Antibodies Announce Issuance Of EU Patents For First-in-Class Monoclonal Antibody Based Sepsis Therapy

LAS VEGAS--(BUSINESS WIRE)--DSX Therapeutics and its close affiliate Research & Diagnostic Antibodies (R&D Ab^®) today announce the European Patent Office has published a Decision to grant patent EP1773390B1 “Improved Therapeutic Agent for iNOS Generating Illness,” which is based upon the ability of the Company’s in vivo neutralizing anti-iNOS monoclonal antibody named aSeptiMab^® to stop the sepsis pathology. Circulating microvesicle-associated inducible nitric oxide synthase (MV-A iNOS) has been shown to play a central role in the onset of sepsis, and blocking MV-A iNOS with aSeptiMab^® has been demonstrated to halt the sepsis cascade prior to organ damage and dysfunction.

“aSeptiMab® is a first-in-class monoclonal antibody candidate therapeutic that represents a paradigm shift for the treatment of the 25 million people each year worldwide who develop sepsis. Once approved, aSeptiMab® will provide doctors with the first targeted drug that is truly effective at treating this life-threatening hyper-inflammatory condition.”

At an average cost of $22,500 – 50,000 (25,000-55,000 €) per patient, sepsis is an enormous healthcare burden in the USA, Europe and around the world. According to Dr. Robert Webber, President and CEO, “aSeptiMab^® is a first-in-class monoclonal antibody candidate therapeutic that represents a paradigm shift for the treatment of the 25 million people each year worldwide who develop sepsis. Once approved, aSeptiMab^® will provide doctors with the first targeted drug that is truly effective at treating this life-threatening hyper-inflammatory condition.”

Together with the patented PliNOSa^® IVD test, which measures plasma levels of MV-A iNOS, aSeptiMab^® will form the perfect companion diagnostic and targeted therapeutic for dramatically improved personalized medicine in patients at risk for developing sepsis or suffering the onset of the sepsis pathology. Since the PliNOSa^® companion IVD test already exists and measures the same molecule in blood that is targeted and neutralized by aSeptiMab^®, this first-in-class candidate therapeutic has a significant advantage over other past tested-and-failed sepsis therapies. DSX Therapeutics anticipates starting an expanded Phase I clinical trial on aSeptiMab^® in the EU and the USA by late 2016 with the intention of gaining approval by the Conditional Market Approval process from the EMA and the Accelerated Approval Process from the US FDA by 2021.

For further information on DSX Therapeutics and Research & Diagnostic Antibodies, or to inquire about partnering opportunities for aSeptiMab^® or PliNOSa^®, please contact Ms. Diane Faber at DSX Therapeutics.