On November 28, 2016 Portola Pharmaceuticals (Nasdaq: PTLA) reported that clinical and preclinical results from studies of all three of its investigational drugs — AndexXa (andexanet alfa), betrixaban and cerdulatinib — will be presented at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is taking place from December 3-6 at the San Diego Convention Center (Press release, Portola Pharmaceuticals, NOV 28, 2016, View Source;p=RssLanding&cat=news&id=2225808 [SID1234516814]).
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AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Betrixaban, which has Fast Track designation from the FDA, is an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Cerdulatinib, an oral, dual Syk/JAK kinase inhibitor, is in development to treat patients with resistant or relapsed hematologic cancer.
The abstracts are now available at View Source Following are details of the oral and poster presentations, which will include additional data not available in the abstracts.
AndexXa (andexanet alfa)
Abstract Title: Reversal of betrixaban-induced anticoagulation in healthy volunteers by andexanet alfa
Publication #: 143
Presenting Author: Mark Crowther, M.D., MSc, FRCPC, Professor, Department of Medicine, Hematology and Thromboembolism and Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario
Oral Session Name: 332. Antithrombotic Therapy: Anticoagulation and Bleeding
Presentation Date and Time: Saturday, December 3, 1:00 p.m. PT
Presentation Location: Room 30
Abstract Title: Andexanet alfa reverses anticoagulation effects of enoxaparin and associated bleeding in a rabbit acute hemorrhage model
Publication #: 1445
Presenting Author: Pamela B. Conley, Ph.D., Vice President, Biology, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 3, 5:30-7:30 p.m. PT
Location: Hall GH
Abstract Title: Andexanet alfa, a universal antidote under development for Factor Xa inhibitors, reverses rivaroxaban-induced inhibition of thrombin generation initiated by the intrinsic coagulation pathway independent of TFPI
Publication #: 3831
Presenting Author: Genmin Lu, Ph.D., Senior Scientist, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Betrixaban
Abstract Title: The safety and efficacy of full versus reduced dose betrixaban in the Acute Medically Ill VTE (venous thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial
Publication #: 3824
Presenting Author: Russell Hull, MBBS, University of Calgary, R.A.H. Faculty of Medicine, Alberta, Canada
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Cerdulatinib
Abstract Title: Regulation of B-cell receptor signalling by the tumour microenvironment in chronic lymphocytic leukemia (CLL) and its impact on adhesion and miRNA expression
Publication #: 351
Presenting Author: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton, Southampton, UK
Oral Session Name: 641. CLL: Biology and Pathophysiology, excluding Therapy: CLL Microenvironment: Cell Intrinsic and Extrinsic Factors
Presentation Date and Time: Sunday, December 4, 10:00 a.m. PT
Location: Room 5AB
Abstract Title: Genetic or CD40L-mediated loss of Iκbα is associated with resistance to the dual SYK/JAK inhibitor cerdulatinib in DLBCL cell lines
Publication #: 2768
Presenting Author: Greg Coffey, Ph.D., Senior Scientist II, Portola Pharmaceuticals
Poster Session Name: 605. Molecular Pharmacology, Drug Resistance — Lymphoid and Other Diseases: Poster II
Presentation Date and Time: Sunday, December 4, 6:00-8:00 p.m. PT
Location: Hall GHNovember 28, 2016) – Portola Pharmaceuticals (Nasdaq: PTLA) reported that clinical and preclinical results from studies of all three of its investigational drugs — AndexXa (andexanet alfa), betrixaban and cerdulatinib — will be presented at the upcoming 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, which is taking place from December 3-6 at the San Diego Convention Center.
AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. Betrixaban, which has Fast Track designation from the FDA, is an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Cerdulatinib, an oral, dual Syk/JAK kinase inhibitor, is in development to treat patients with resistant or relapsed hematologic cancer.
The abstracts are now available at View Source Following are details of the oral and poster presentations, which will include additional data not available in the abstracts.
AndexXa (andexanet alfa)
Abstract Title: Reversal of betrixaban-induced anticoagulation in healthy volunteers by andexanet alfa
Publication #: 143
Presenting Author: Mark Crowther, M.D., MSc, FRCPC, Professor, Department of Medicine, Hematology and Thromboembolism and Pathology and Molecular Medicine, McMaster University, Hamilton, Ontario
Oral Session Name: 332. Antithrombotic Therapy: Anticoagulation and Bleeding
Presentation Date and Time: Saturday, December 3, 1:00 p.m. PT
Presentation Location: Room 30
Abstract Title: Andexanet alfa reverses anticoagulation effects of enoxaparin and associated bleeding in a rabbit acute hemorrhage model
Publication #: 1445
Presenting Author: Pamela B. Conley, Ph.D., Vice President, Biology, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 3, 5:30-7:30 p.m. PT
Location: Hall GH
Abstract Title: Andexanet alfa, a universal antidote under development for Factor Xa inhibitors, reverses rivaroxaban-induced inhibition of thrombin generation initiated by the intrinsic coagulation pathway independent of TFPI
Publication #: 3831
Presenting Author: Genmin Lu, Ph.D., Senior Scientist, Portola Pharmaceuticals
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Betrixaban
Abstract Title: The safety and efficacy of full versus reduced dose betrixaban in the Acute Medically Ill VTE (venous thromboembolism) Prevention with Extended Duration Betrixaban (APEX) trial
Publication #: 3824
Presenting Author: Russell Hull, MBBS, University of Calgary, R.A.H. Faculty of Medicine, Alberta, Canada
Poster Session Name: 332. Antithrombotic Therapy: Poster III
Presentation Date and Time: Monday, December 5, 6:00-8:00 p.m. PT
Location: Hall GH
Cerdulatinib
Abstract Title: Regulation of B-cell receptor signalling by the tumour microenvironment in chronic lymphocytic leukemia (CLL) and its impact on adhesion and miRNA expression
Publication #: 351
Presenting Author: Andrew Steele, Ph.D., Associate Professor, Medicine, University of Southampton, Southampton, UK
Oral Session Name: 641. CLL: Biology and Pathophysiology, excluding Therapy: CLL Microenvironment: Cell Intrinsic and Extrinsic Factors
Presentation Date and Time: Sunday, December 4, 10:00 a.m. PT
Location: Room 5AB
Abstract Title: Genetic or CD40L-mediated loss of Iκbα is associated with resistance to the dual SYK/JAK inhibitor cerdulatinib in DLBCL cell lines
Publication #: 2768
Presenting Author: Greg Coffey, Ph.D., Senior Scientist II, Portola Pharmaceuticals
Poster Session Name: 605. Molecular Pharmacology, Drug Resistance — Lymphoid and Other Diseases: Poster II
Presentation Date and Time: Sunday, December 4, 6:00-8:00 p.m. PT
Location: Hall GH