Perosphere Inc., a specialty pharmaceutical company, provides drug delivery technology. Its drug delivery technology enables localized and systemic delivery, alters pharmacokinetics and pharmacodynamics to improve controlled release formulations, and reduces inter and intra-patient variability. The company’s drug delivery technology is used in drug candidates, such as PER726, an intravenous therapeutic drug; PER921 and PER922, which are oral solid dose therapeutic drugs; PER923, a low dose administration of a therapeutic drug; PER1080, a rapid-acting formulation of a therapeutic drug; and PER977 to reverse the anticoagulant activity of unfractionated heparin, low molecular weight heparins, f...
24 Old Wagon Road
Bedford, NY 10549
Founded in 2011
Perosphere Inc. Receives FDA IND Clearance to Initiate Clinical Investigations of the Safety and Efficacy of PER977
May 22 13
Perosphere Inc. announced that it has received U.S. Food and Drug Administration investigational new drug 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.
Perosphere Inc. and Daiichi Sankyo Company, Limited Enter into Clinical Trial Agreement
Apr 25 13
Perosphere Inc. and Daiichi Sankyo Company, Limited announced that they have entered into a clinical trial agreement under which Daiichi Sankyo will support and co-sponsor a phase 1 clinical study testing the safety, tolerability and effectiveness of PER977 to reverse the anticoagulant activity of edoxaban, Daiichi Sankyo's investigational oral, once-daily, direct factor Xa-inhibitor.(1,2,3) PER977 is a synthetic, small new molecular entity being developed by Perosphere that has been shown in pre-clinical studies to directly bind to heparins as well as circulating direct factor Xa- and IIa-inhibitors and therefore has the potential to reverse their anticoagulant effect.(4,5,6,7) PER977 does not bind to blood coagulation factors or other blood proteins.(5) In pre-clinical studies, PER977 has demonstrated the ability to reverse the anticoagulant effects of direct factor Xa- and IIa-inhibitors in vitro and ex vivo in animal and human models.(4,6,7) PER977 reverses anticoagulant activity within 30 minutes after intravenous administration and has a clearance half-life of approximately 1.5 hours.(5) Edoxaban is 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.(1,8) Edoxaban is currently approved only in Japan, since April 2011, for the prevention of venous thromboembolism (VTE) after major orthopaedic surgery, under the brand name Lixiana(R). Elsewhere, including Europe and the U.S., edoxaban is currently in phase 3 of clinical development and has not been approved. The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation), which are evaluating edoxaban, administered once-daily, for treatment and prevention of recurrence of VTE in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and for the prevention of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation, respectively.