Horizon scanning: Phase II study to evaluate an antidote to Factor Xa inhibitors

Source: PharmaLive Area: News Portola Pharmaceuticals has announced a clinical collaboration agreement with Bayer HealthCare and Janssen Pharmaceuticals for a phase II study which will evaluate the potential of the novel recombinant protein PRT4445 as a universal  antidote to Factor Xa inhibitor blood thinners.   Results of a Phase 1 single ascending dose safety and tolerability study, conducted in 32 healthy volunteers in the United States, showed that PRT4445 was generally well tolerated with no apparent safety signals.   The phase II study will report on the safety and efficacy of PRT445 in healthy volunteers who have been administered rivaroxaban and are experiencing an uncontrolled bleeding episode or requiring emergency surgery. Results are expected during the second half of 2013.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news