Clearance also includes Clinical Investigation of PER977 to Reverse the Anticoagulation Activity of Unfractionated Heparin, Low Molecular Weight Heparins, and Fondaparinux
MOUNT KISCO, NY, USA I May 22, 2013 I Perosphere Inc. announced today that it has received U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to initiate clinical investigations of the safety and efficacy of PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors. PER977 has demonstrated the ability to reverse the anticoagulant effects of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors in vitro in animal models and ex vivo in human blood.
Perosphere will initially test the ability of PER977 to reverse the anticoagulant activity of edoxaban in a Phase I clinical trial. Daiichi Sankyo Company, Limited is developing edoxaban, an investigational, oral, once-daily anticoagulant that specifically and reversibly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. Perosphere and Daiichi Sankyo have previously announced that Daiichi Sankyo is co-sponsoring the Phase I clinical trial. The clinical trial will be conducted by the Duke Clinical Research Unit, the early-phase unit of the Duke Clinical Research Institute at the Duke University School of Medicine.
“Some drug candidates under evaluation as potential reversal agents of factor Xa- or IIa-inhibitors are biological agents that are being developed as antidotes to specific anticoagulants or anticoagulant families,” stated Dr. Solomon S. Steiner, CEO of Perosphere. “PER977 has the potential to be a universal antidote for both factor Xa- and IIa-inhibitors as well as heparins and certain other anticoagulants. Additionally, as a synthetic small molecule PER977 may offer advantages over biological agents.”
About Perosphere
Perosphere is a specialty pharmaceutical company that identifies and develops new chemical entities and other therapeutics that can be used as “rescue” drugs. For more information, please visit www.perosphere.com.
SOURCE: Perosphere
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Clearance also includes Clinical Investigation of PER977 to Reverse the Anticoagulation Activity of Unfractionated Heparin, Low Molecular Weight Heparins, and Fondaparinux
MOUNT KISCO, NY, USA I May 22, 2013 I Perosphere Inc. announced today that it has received U.S. Food and Drug Administration (“FDA”) Investigational New Drug (“IND”) clearance to initiate clinical investigations of the safety and efficacy of PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors. PER977 has demonstrated the ability to reverse the anticoagulant effects of unfractionated heparin, low molecular weight heparins, fondaparinux, and factor Xa- and IIa-inhibitors in vitro in animal models and ex vivo in human blood.
Perosphere will initially test the ability of PER977 to reverse the anticoagulant activity of edoxaban in a Phase I clinical trial. Daiichi Sankyo Company, Limited is developing edoxaban, an investigational, oral, once-daily anticoagulant that specifically and reversibly inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. Perosphere and Daiichi Sankyo have previously announced that Daiichi Sankyo is co-sponsoring the Phase I clinical trial. The clinical trial will be conducted by the Duke Clinical Research Unit, the early-phase unit of the Duke Clinical Research Institute at the Duke University School of Medicine.
“Some drug candidates under evaluation as potential reversal agents of factor Xa- or IIa-inhibitors are biological agents that are being developed as antidotes to specific anticoagulants or anticoagulant families,” stated Dr. Solomon S. Steiner, CEO of Perosphere. “PER977 has the potential to be a universal antidote for both factor Xa- and IIa-inhibitors as well as heparins and certain other anticoagulants. Additionally, as a synthetic small molecule PER977 may offer advantages over biological agents.”
About Perosphere
Perosphere is a specialty pharmaceutical company that identifies and develops new chemical entities and other therapeutics that can be used as “rescue” drugs. For more information, please visit www.perosphere.com.
SOURCE: Perosphere
Post Views: 132
