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Portola Pharmaceuticals Announces Presentation of Preclinical Data on Andexanet Alfa (PRT4445), Factor Xa Inhibitor Antidote, at 2013 European Society of Cardiology Congress
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 29, 2013--
“These data from a preclinical animal model are noteworthy because they demonstrate that the reversal of Factor Xa anticoagulant activity by andexanet alfa has the potential to reduce blood loss in anticoagulated patients experiencing an active bleed, an important point of differentiation with this compound,” said
Details of the moderated poster presentation follow:
Abstract title: PRT064445 (Andexanet Alfa) Reverses Rivaroxaban Induced Anticoagulation in a Rabbit Liver Laceration “Treatment” Model
Session: Antithrombotic Agents
Location: Moderated Posters -- Village 9
The andexanet alfa abstract is now publically available at http://spo.escardio.org/.
About Andexanet Alfa
Andexanet alfa (proposed INN) is a novel recombinant, modified Factor Xa molecule designed to reverse the anticoagulant activity in patients treated with a Factor Xa inhibitor who suffer an uncontrolled bleeding episode or need to undergo emergency surgery. Andexanet alfa is similar to native Factor Xa, but has been modified to restrict its biological activity to the reversal of the anticoagulant effects of Factor Xa inhibitors. Andexanet alfa acts as a Factor Xa decoy that binds and sequestors direct Factor Xa inhibitors in the blood. Once bound to andexanet alfa, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa. The native Factor Xa is then available to participate in the coagulation process and restore hemostasis.
Results from a Phase 1 single ascending dose safety and tolerability study of andexanet alfa conducted by Portola in 32 healthy volunteers showed no apparent safety signals, including no thrombotic adverse events and no antibodies against andexanet alfa, endogenous Factor Xa or Factor X. Results from a Phase 2 proof-of-concept study of andexanet alfa were presented at the 2013
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the potential efficacy and use of andexanet alfa to reverse the anticoagulant activity in patients treated with a Factor Xa inhibitor and the timing of the reporting of Phase 2 study data. Risks that contribute to the uncertain nature of the forward-looking statements include the accuracy of Portola’s estimates regarding its ability to complete its clinical studies and the success of Portola’s clinical studies and the demonstrated efficacy of Portola’s product candidates thereunder. These and other risks and uncertainties are described more fully in Portola's filings with the
*PRT4445 has a proposed International Nonproprietary Name (pINN) of andexanet alfa.