PORTOLA PHARMACEUTICALS, INC.
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 SykJak 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.
Forward-looking Statements
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 likelihood of clinical, regulatory and commercial success of our product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the accuracy of Portola's estimates regarding its ability to initiate and/or complete its clinical trials; the success of Portola's clinical trials and the demonstrated efficacy of Portola's product candidates to the satisfaction of regulatory authorities; the accuracy of Portola's estimates regarding its expenses and capital requirements; regulatory developments in the United States and foreign countries; Portola's ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Portola's most recent filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K, which was filed on March 2, 2015, and Quarterly Report on Form 10-Q, which was filed on November 9, 2015. 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.
Investor Contact: Ana Kapor Portola Pharmaceuticals ir@portola.com Media Contact: Julie Normart W2O Group jnormart@w2ogroup.com
