SOUTH SAN FRANCISCO, Calif., Nov. 6, 2014 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals (Nasdaq:PTLA) today announced that its programs in thrombosis and hematology will be highlighted in poster sessions at the upcoming American Society of Hematology (ASH) Annual Meeting, which is taking place from December 6-9 in San Francisco. Presentations will include results from a Phase 2 proof-of-concept study of andexanet alfa, an FDA-designated breakthrough therapy and potential first-in-class Factor Xa inhibitor antidote, and the investigational oral Factor Xa inhibitor edoxaban being developed by Daiichi Sankyo. In addition, interim Phase 1 data with cerdulatinib, an oral dual Syk/JAK inhibitor, in patients with relapsed/refractory chronic lymphocytic leukemia and B-cell non-Hodgkin lymphoma will be presented. The Phase 1 study is designed to determine the maximum tolerated dose for the agent, and the study is still ongoing.
The abstracts are now available at www.hematology.org. Details of the poster presentations, which will include additional data not currently available in the published abstracts, follow.
Andexanet Alfa
- Abstract Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial Demonstrating Reversal of Edoxaban-Induced Anticoagulation in Healthy Subjects by Andexanet Alfa (PRT064445), a Universal Antidote for Factor Xa (fXa) Inhibitors (abstract #4269)
Presenting Author: Mark Crowther, M.D., M.Sc., associate chair, Department of Medicine, McMaster University, Hamilton, Ontario
Session Name: 332. Antithrombotic Therapy: Poster III
Poster Presentation Date, Time and Location: Monday, December 8, at 6:00 p.m. PT, Moscone Center, West Building, Level 1
Cerdulatinib
- Abstract Title: Study of the Dual Syk/Jak Inhibitor PRT062070 (Cerdulatinib) in Patients with Relapsed/Refractory B Cell Malignancies (abstract #3103)
Presenting Author: Manish R. Patel, M.D., hematologist/oncologist at Florida Cancer Specialists in Sarasota
Session Name: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Poster II
Poster Presentation Date, Time and Location: Sunday, December 7, at 6:00 p.m. PT, Moscone Center, West Building, Level 1
- Abstract Title: SYK and STAT3 Are Active in Diffuse Large B-cell Lymphoma: Activity of Cerdulatinib, a Dual SYK/JAK Inhibitor (abstract #926)
Presenting Author: Y. Lynn Wang M.D., Ph.D., FCAP., medical director, Division of Genomic and Molecular Pathology at the University of Chicago
Session Name: 605. Molecular Pharmacology, Drug Resistance – Lymphoid and Other Diseases: Poster I
Poster Presentation Date, Time and Location: Saturday, December 6, at 5:30 p.m. PT, Moscone Center, North Building, Hall E
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. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions.
Betrixaban
Portola's wholly-owned, oral, once-daily Factor Xa inhibitor betrixaban is being evaluated in the only biomarker-based Phase 3 study for hospital-to-home prophylaxis of venous thromboembolism (VTE) in acute medically ill patients. Betrixaban's distinct properties may have the potential to allow the agent to demonstrate efficacy without the significant increase in the rate of major bleeding that was seen in this patient population with other Factor Xa inhibitors. If approved, betrixaban could be the first anticoagulant for both hospital and post-discharge VTE prophylaxis and the standard of care in this large market of more than 20 million patients in the G7 countries alone.
Andexanet Alfa
Andexanet alfa, a recombinant modified human Factor Xa molecule, has the potential to be a first-in-class antidote to reverse the effects of Factor Xa inhibitors in patients who suffer a major bleeding episode or who require emergency surgery. Andexanet alfa has been designated as a breakthrough therapy by the FDA. Portola has entered into Phase 3 clinical collaboration agreements with all of the manufacturers of direct Factor Xa inhibitors – Bristol-Myers Squibb and Pfizer (Eliquis [apixaban]), Bayer HealthCare and Janssen Pharmaceuticals (XARELTO® [rivaroxaban]), and Daiichi Sankyo (edoxaban) – while retaining all commercial rights to andexanet alfa. The Company is currently evaluating andexanet alfa in the Phase 3 ANNEXA™ (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of fXa Inhibitors) registration studies.
Cerdulatinib* (PRT2070)
Portola's product candidate in the area of hematologic cancer, cerdulatinib, is an orally available molecule that uniquely inhibits two validated tumor proliferation pathways – spleen tyrosine kinase (Syk) and janus kinase (JAK). It is currently being evaluated in a Phase 1/2 proof-of-concept study in patients with B cell leukemias or lymphomas with a focus on genetically-defined subtypes, as well as in patients who have failed therapy due to relapse or acquired mutations.
For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma.
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: Portola's plans for future clinical studies, timing of clinical study results, future regulatory filings, and the potential efficacy, safety and activity of Portola's 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 thereunder; the accuracy of Portola's estimates regarding its expenses and capital requirements; Portola's ability to manufacture andexanet alfa; 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 and most recent Quarterly Report on Form 10-Q. 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.
*Cerdulatinib is a proposed International Nonproprietary Name (pINN).