Portola Announces Oral Presentation of Phase 2 Data on PRT4445, Factor Xa Inhibitor Antidote, at 2013 International Society on Thrombosis and Haemostasis Congress

Loading...
Loading...
Portola Pharmaceuticals, Inc.
PTLA
today announced that safety and pharmacodynamic data from a Phase 2 trial of its investigational Factor Xa inhibitor antidote PRT4445 in healthy volunteers who were administered the Factor Xa inhibitor Eliquis® (apixaban) will be presented in an oral session at the upcoming XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH), which is taking place in Amsterdam from June 29-July 4. Details of the oral presentation follow: Abstract title: A Phase 2 randomized, double-blind, placebo-controlled trial of PRT4445, a novel, universal antidote for direct and indirect Factor Xa inhibitors Session: Abstract symposium: New developments in treatment of venous thrombosis Presentation date/time: Tuesday, July 2, 1:30-1:45 CET Location: Elicium 2 Presenter: Mark Crowther, M.D., M.Sc., FRCPC, professor in the Department of Medicine, Hematology and Thromboembolism, McMaster University, Hamilton, Ontario PRT4445, which has a tentatively approved International Nonproprietary Name (INN) of andexanet alfa, is a recombinant protein designed to reverse the anticoagulant activity in patients treated with a Factor Xa inhibitor who suffer an uncontrolled bleeding episode or undergo emergency surgery. Clinical trial results suggest that patients treated with novel oral anticoagulants may experience uncontrolled bleeding (annually between 1 and 4 percent) and some may require emergency surgery. The lack of an effective reversal agent, or antidote, for patients on Factor Xa inhibitors is an unmet need as currently there is no such agent approved for use against Factor Xa inhibitors. Portola entered into a collaboration agreement with Bristol-Myers Squibb Company and Pfizer Inc. to study andexanet alfa with Eliquis® in the Phase 2 study. Portola retains full, worldwide commercial rights with respect to andexanet alfa. About Portola Pharmaceuticals, Inc. Portola is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis (blood clots), other hematologic disorders and inflammation for patients who currently have limited or no approved treatment options. Portola's current development-stage portfolio consists of three compounds discovered through its internal research efforts and one discovered by Portola scientists during their time at a prior company. Portola's two lead programs address significant unmet medical needs in the area of thrombosis. Portola's lead compound, betrixaban, is an investigational, novel, oral, once-daily inhibitor of Factor Xa in Phase 3 development for extended duration prophylaxis (preventive treatment) of a form of thrombosis known as venous thromboembolism (VTE) in acute medically ill patients. Currently, there is no anticoagulant approved for extended duration VTE prophylaxis in this population. Portola's second lead development candidate, andexanet alfa, is a recombinant protein 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. Portola has entered into collaboration agreements with Bristol-Myers Squibb Company and Pfizer Inc. and with Bayer Pharma AG and Janssen Pharmaceuticals, Inc., to study andexanet alfa with Eliquis® (apixaban) and XARELTO® (rivaroxaban), respectively, in Portola's Phase 2 studies. Portola retains full, worldwide commercial rights with respect to andexanet alfa. Portola's third product candidate, PRT2070, is an orally available kinase inhibitor being developed for hematologic (blood) cancers and inflammatory disorders. PRT2070 inhibits spleen tyrosine kinase (Syk) and janus kinases (JAK), enzymes that regulate important signaling pathways. Subject to regulatory approval, Portola plans to initiate a Phase 1/2 clinical study of PRT2070 in 2013 in patients with B-cell hematologic cancers who have failed or relapsed on existing marketed therapies or products in development, including patients with identified mutations. Portola's fourth program, PRT2607 and other highly selective Syk inhibitors, is partnered with Biogen Idec Inc.
Loading...
Loading...
Posted In: NewsPress Releases
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...