Portola Pharmaceuticals Announces Presentation of Preclinical Data on Andexanet Alfa (PRT44545), Fac
Portola Pharmaceuticals Announces Presentation of Preclinical Data on Andexanet Alfa (PRT44545), Factor Xa Inhibitor Antidote, at 2013 European Society of Cardiology Congress
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Portola Pharmaceuticals, Inc. (NAS: PTLA) today announced that it will present preclinical data on its investigational Factor Xa inhibitor antidote andexanet alfa (PRT4445*) in a moderated poster session at the upcoming 2013 European Society of Cardiology (ESC) Congress, which is taking place in Amsterdam from August 31-September 4.
"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 John T. Curnutte, M.D., Ph. D., executive vice president of research and development for Portola. "We have already established in a Phase 2 clinical study that andexanet alfa can reverse the anticoagulant activity of the Factor Xa inhibitor Eliquis® (apixaban), and, as part of an accelerated development plan, we expect to initiate a pivotal study in 2014 to further assess the effects of andexanet alfa on bleeding."
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
Presentation date/time: August 31, 2013, 16:22 p.m. CEST
Location: Moderated Posters -- Village 9
Moderator: Stanley Hollenbach, J.D., vice president, pharmacology, Portola Pharmaceuticals
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 Congress of the International Society on Thrombosis and Haemostasis, demonstrating reversal of the anticoagulant activity of Bristol-Myers Squibb's and Pfizer's Factor Xa inhibitor Eliquis® (apixaban).
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis, other hematologic disorders and inflammation. Portola's wholly-owned lead compound, betrixaban, is a novel, oral, once-daily Factor Xa inhibitor in Phase 3 development for extended-duration prophylaxis of a form of thrombosis known as venous thromboembolism (VTE) in acute medically ill patients.Portola's second lead development candidate, andexanet alfa (PRT4445), is a recombinant protein in Phase 2 development for which Portola retains full, worldwide commercial rights. It is designed to reverse the anticoagulant activity in patients treated with a Factor Xa inhibitor who suffer an uncontrolled bleeding episode or require emergency surgery. Portola's third product candidate, PRT2070, is an orally available kinase inhibitor that inhibits both spleen tyrosine kinase (Syk) and janus kinases (JAK). It is targeted at patients with genetically-defined hematologic cancers. Portola's fourth program, PRT2607 and other highly selective Syk inhibitors, is partnered with Biogen Idec. For more information, visit www.portola.com.
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 Securities and Exchange Commission, including without limitation its Quarterly Report on Form 10-Q, which was filed with the Securities and Exchange Commission on August 14, 2013. All forward-looking statements contained in this press release speak only as of the date on which they were made. Portola undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
*PRT4445 has a proposed International Nonproprietary Name (pINN) of andexanet alfa.
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