SOUTH SAN FRANCISCO, Calif., Dec. 3, 2013 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc. (Nasdaq: PTLA ) today announced two upcoming data presentations at the 55 th American Society of Hematology (ASH) Annual Meeting and Exposition, which is being held in New Orleans from December 7-10. The Company also will webcast an investor briefing during the ASH Annual Meeting.
New data from a Phase 2 proof-of-concept study of andexanet alfa (PRT4445*), Portola's investigational Factor Xa inhibitor antidote, in healthy volunteers who received the Factor Xa inhibitor XARELTO ® (rivaroxaban) will be presented in a poster session. Andexanet alfa has been designated as a breakthrough therapy by the U.S. Food and Drug Administration, and has the potential to be a first-in-class agent that directly reverses the anticoagulant activity of Factor Xa inhibitors in patients with major bleeding or those needing emergency surgery.
Additionally, in vitro data on PRT2070, Portola's oral, dual spleen tyrosine kinase (Syk) and janus kinase (JAK) inhibitor, will be presented in a poster session. Portola is developing PRT2070 as a treatment for hematologic cancers and is evaluating the agent in a Phase 1/2 proof-of-concept clinical study in patients with non-Hodgkin's lymphoma or chronic lymphocytic leukemia, including those patients who have progressive or relapsed disease, genetically-defined subtypes or acquired mutations.
The abstracts are available at https://ash.confex.com/ash/2013/webprogram/Paper56863.html and https://ash.confex.com/ash/2013/webprogram/Paper63738.html and were published online in the November 15 supplemental volume of Blood . Details of the poster presentations and investor briefing webcast follow.
Andexanet Alfa
- Abstract title: Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial Demonstrating Reversal of Rivaroxaban-Induced Anticoagulation in Healthy Subjects By Andexanet Alfa (PRT064445), an Antidote for Fxa Inhibitors
- Poster Presenter: Mark Crowther, M.D., M.Sc., associate chair, Department of Medicine, McMaster University, Hamilton, Ontario
- Date/Time: Monday, December 9, 6:00-8:00 p.m. Central Time (CT)
- Session: 332. Antithrombotic Therapy: Poster III
- Location: Ernest N. Morial Convention Center, Hall E
PRT2070
- Abstract title: Dual SYK/JAK Inhibition Has a Broader Anti-Tumor Activity in Both ABC and GCB Types of Diffuse Large B Cell Lymphoma
- Poster Presenter: Y. Lynn Wang, M.D., Ph.D., professor and medical director, Division of Genomic and Molecular Pathology, Department of Pathology, University of Chicago
- Date/Time: Saturday, December 7, 5:30-7:30 p.m. CTSession: 625. Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents: Poster I
- Location: Ernest N. Morial Convention Center, Hall G
Investor Briefing Webcast Details
Portola will host an investor briefing on Monday, December 9, at 2:05 p.m. Central Time (3:05 p.m. Eastern Time) during the ASH Annual Meeting in New Orleans. During the event, Portola's senior management team will provide an update on the Company's recent business progress. A live webcast of the event will be available via the Investor Relations section of the Company's website at http://investors.portola.com . A replay will be available on the Company's website for 30 days following the live event.
About Portola Pharmaceuticals, Inc.
Robust thrombosis and hematology pipeline with betrixaban, andexanet alfa and PRT2070
Portola Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of novel therapeutics in the areas of thrombosis and hematology.
Betrixaban
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 venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's properties may be uniquely suited to potentially demonstrate efficacy without significantly increasing bleeding in this patient population. Currently, there is no anticoagulant approved for extended-duration VTE prophylaxis in acute medically ill patients.
Andexanet Alfa (PRT4445*)
Portola's second lead development candidate, andexanet alfa (PRT4445*), has the potential to be a first-in-class universal antidote to reverse the effects of Factor Xa inhibitors in patients who suffer an uncontrolled bleeding episode or who require emergency surgery. Portola retains full, worldwide commercial rights to andexanet alfa, which has been designated as a breakthrough therapy by the U.S. Food and Drug Administration.
PRT2070 and PRT2607
Portola's third product candidate, PRT2070, is an orally available kinase inhibitor that uniquely inhibits two validated tumor proliferation pathways -- spleen tyrosine kinase (Syk) and janus kinase (JAK). It is currently being studied in patients with genetically-defined hematologic cancers, as well as for patients who have failed therapy due to relapse or acquired mutations. Portola's fourth program is partnered with Biogen Idec and is focused on the development of PRT2607, a selective Syk inhibitor. For more information, visit www.portola.com .
Forward-looking statement
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, safety and activity of betrixaban, andexanet alfa and PRT2070. 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 thereunder; 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. 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.
Investor Contact: Alexandra Santos Portola Pharmaceuticals 650.246.7239 Media Contact: Joey Fleury BrewLife 415.946.1090
