Portola Announces Andexanet Alfa And Cerdulatinib Data Presentations At The 2015 American Society of Hematology Annual Meeting And Exposition
SOUTH SAN FRANCISCO, Calif., Dec. 05, 2015 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (Nasdaq:PTLA) today announced the presentation of new results from clinical and non-clinical studies of two of its investigational pipeline products – the Factor Xa inhibitor reversal agent andexanet alfa and the oral, dual Syk/JAK kinase inhibitor cerdulatinib – at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Fla.
Andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors. Portola is developing it as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled bleeding event or who require urgent or emergent surgery. Cerdulatinib inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies. Portola is developing it to treat patients with hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies.
The abstracts are now available at http://www.hematology.org. All posters will be presented in Hall A of the Orange County Convention Center.
Andexanet Alfa
• Abstract Title (#1135): Pharmacokinetic and Pharmacodynamic (PKPD) Modeling to Determine the Andexanet Alfa Dose to Reverse the Anticoagulant Activity of Direct Fxa Inhibitors
Presenting Author: Janet Leeds, Ph.D., senior director, DMPK at Portola
Poster Session Title: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 5: 5:30-7:30 p.m.
• Abstract Title (#2329): Reversal of Heparin-Induced Anticoagulation By Andexanet Alfa, a Universal Antidote for Factor Xa Inhibitors
Presenting Author: Genmin Lu, Ph.D., senior scientist at Portola
Poster Session Title: 332. Antithrombotic Therapy: Poster II
Presentation Date and Time: Sunday, December 6: 6:00-8:00 p.m. Cerdulatinib
• Abstract Title (#1716): The Syk\Jak Inhibitor Cerdulatinib (PRT062070) Shows Promising Preclinical Activity in Chronic Lymphocytic Leukemia By Antagonizing B Cell Receptor and Micro-environmental Signaling
Presenting Author: Andrew Steele BSc (Hons), M.Phil., Ph.D., University of Southampton, U.K.
Poster Session Title: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster I
Presentation Date and Time: Saturday, December 5: 5:30-7:30 p.m.
• Abstract Title (#3929): Clinical and Correlative Results of a Phase 1 Study of Cerdulatinib (PRT062070), a Dual SYK/JAK Inhibitor in Patients with Relapsed/Refractory B Cell Malignancies
Presenting Author: Paul Hamlin, M.D., Memorial Sloan-Kettering Cancer Center
Poster Session Title: 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: Poster III
Presentation Date and Time: Monday, December 7, 6:00-8:00 p.m.
• Abstract Title (#3706): Predicting Cerdulatinib Therapeutic Concentrations in Patients with Relapsed/Refractory B Cell Malignancies Using Preclinical Models and Clinical PK/PD and Tumor Response Correlates
Presenting Author: Greg Coffey, Ph.D., senior scientist in biology at Portola
Poster Session Title: 605. Molecular Pharmacology, Drug Resistance – Lymphoid and Other Diseases: Poster III
Presentation Date and Time: Monday, December 7, 6:00-8:00 p.m.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing its three wholly-owned programs using novel biomarker and genetic approaches that may increase the likelihood of clinical, regulatory and commercial success of its potentially life-saving therapies. These programs include betrixaban, an oral, once-daily Factor Xa inhibitor being evaluated in the APEX Phase 3 study for prophylaxis of venous thromboembolism; andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.
Andexanet alfa, a U.S. Food and Drug Administration (FDA)-designated breakthrough therapy, is a recombinant protein specifically designed to reverse the anticoagulant activity of both direct and indirect Factor Xa inhibitors. Portola is developing it as a universal reversal agent for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled bleeding event or who require urgent or emergent surgery. Cerdulatinib inhibits two key cell signaling pathways that promote cancer cell growth in certain hematologic malignancies. Portola is developing it to treat patients with hematologic cancers, specifically those who have relapsed or who have not responded to prior therapies.
The abstracts are now available at http://www.hematology.org. All posters will be presented in Hall A of the Orange County Convention Center.
Andexanet Alfa
• Abstract Title (#1135): Pharmacokinetic and Pharmacodynamic (PKPD) Modeling to Determine the Andexanet Alfa Dose to Reverse the Anticoagulant Activity of Direct Fxa Inhibitors
Presenting Author: Janet Leeds, Ph.D., senior director, DMPK at Portola
Poster Session Title: 332. Antithrombotic Therapy: Poster I
Presentation Date and Time: Saturday, December 5: 5:30-7:30 p.m.
• Abstract Title (#2329): Reversal of Heparin-Induced Anticoagulation By Andexanet Alfa, a Universal Antidote for Factor Xa Inhibitors
Presenting Author: Genmin Lu, Ph.D., senior scientist at Portola
Poster Session Title: 332. Antithrombotic Therapy: Poster II
Presentation Date and Time: Sunday, December 6: 6:00-8:00 p.m. Cerdulatinib
• Abstract Title (#1716): The Syk\Jak Inhibitor Cerdulatinib (PRT062070) Shows Promising Preclinical Activity in Chronic Lymphocytic Leukemia By Antagonizing B Cell Receptor and Micro-environmental Signaling
Presenting Author: Andrew Steele BSc (Hons), M.Phil., Ph.D., University of Southampton, U.K.
Poster Session Title: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster I
Presentation Date and Time: Saturday, December 5: 5:30-7:30 p.m.
• Abstract Title (#3929): Clinical and Correlative Results of a Phase 1 Study of Cerdulatinib (PRT062070), a Dual SYK/JAK Inhibitor in Patients with Relapsed/Refractory B Cell Malignancies
Presenting Author: Paul Hamlin, M.D., Memorial Sloan-Kettering Cancer Center
Poster Session Title: 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: Poster III
Presentation Date and Time: Monday, December 7, 6:00-8:00 p.m.
• Abstract Title (#3706): Predicting Cerdulatinib Therapeutic Concentrations in Patients with Relapsed/Refractory B Cell Malignancies Using Preclinical Models and Clinical PK/PD and Tumor Response Correlates
Presenting Author: Greg Coffey, Ph.D., senior scientist in biology at Portola
Poster Session Title: 605. Molecular Pharmacology, Drug Resistance – Lymphoid and Other Diseases: Poster III
Presentation Date and Time: Monday, December 7, 6:00-8:00 p.m.
About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing its three wholly-owned programs using novel biomarker and genetic approaches that may increase the likelihood of clinical, regulatory and commercial success of its potentially life-saving therapies. These programs include betrixaban, an oral, once-daily Factor Xa inhibitor being evaluated in the APEX Phase 3 study for prophylaxis of venous thromboembolism; andexanet alfa, a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.