Portola Pharmaceuticals Announces Phase 3 ANNEXA™-R Part 2 Study Results to be Presented at American Heart Association Scie...
06 Novembre 2015 - 2:00PM
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that full
data from the second part of its Phase 3 ANNEXA™-R (Andexanet Alfa
a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors –
Rivaroxaban) study of the investigational agent andexanet alfa will
be presented during a Late-Breaking Clinical Trial oral session at
the upcoming American Heart Association (AHA) Scientific Sessions,
which is taking place from November 7-11 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 in
patients treated with an oral or injectable Factor Xa inhibitor.
Portola is developing it as a universal reversal agent for patients
anticoagulated with an oral or injectable Factor Xa inhibitor who
suffer a major bleeding episode or require emergency surgery.
The ANNEXA-R study evaluated the safety and
efficacy of andexanet alfa in reversing the anticoagulant effect of
the Factor Xa inhibitor rivaroxaban, as measured by anti-Factor Xa
activity, in older healthy volunteers. Part 1 of the study
demonstrated rapid reversal with an IV bolus infusion, and topline
data from Part 2 showed the ability of andexanet alfa administered
as an IV bolus followed by a continuous two-hour infusion to
sustain that reversal for the duration of the infusion. In the
study, andexanet alfa was well tolerated, with no serious or severe
adverse events, no thrombotic events, and no antibodies to Factor X
or Xa observed.
Following are details of the Late-Breaking oral
presentation, which will include additional data beyond what has
been previously announced.
Abstract Title: |
ANNEXA™-R Part 2: A Phase 3 Randomized, Double-Blind,
Placebo-Controlled Trial Demonstrating Sustained Reversal of
Rivaroxaban-Induced Anticoagulation in Older Subjects by Andexanet
Alfa (PRT064445), a Universal Antidote for Factor XA (FXA)
Inhibitors |
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Presenting Author: |
Mark
Crowther, M.D., MSc., professor in the Department of Medicine,
Hematology and Thromboembolism and Pathology and Molecular
Medicine, McMaster University, Hamilton Ontario |
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Session Title: |
Novel
Therapies for Common Problems |
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Date, Time and Location: |
Wednesday, November 11, at 10:45 a.m. ET, Chapin
Theater |
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About Andexanet AlfaAndexanet alfa
is a modified human Factor Xa molecule that acts as a decoy to
target and sequester with high specificity both oral and injectable
Factor Xa inhibitors in the blood. Once bound, the Factor Xa
inhibitors are unable to bind to and inhibit native Factor Xa, thus
allowing for the restoration of normal hemostatic processes.
Andexanet alfa is the only compound being studied as a reversal
agent for Factor Xa inhibitors that directly and specifically
corrects anti-Factor Xa activity – the anticoagulant mechanism of
these agents.
Portola is currently evaluating andexanet alfa in
ANNEXA-4, a Phase 4 single-arm confirmatory study in patients
receiving apixaban, rivaroxaban, edoxaban or enoxaparin (a low
molecular weight heparin and indirect Factor Xa inhibitor) who
present with an acute major bleed. Data from a small number of
patients from ANNEXA-4, as well as data from ANNEXA-A and ANNEXA-R,
will serve as the clinical basis of a Biologics License Application
(BLA), which Portola plans to submit to the FDA by the end of this
year.
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
(VTE); 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
StatementStatements 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: andexanet alfa's potential as a reversal
agent for patients anticoagulated with an oral or injectable Factor
Xa inhibitor who suffer a major bleeding episode or require
emergency surgery, Portola's plans for pursuit of regulatory
approval of andexanet alfa, and the likelihood of clinical,
regulatory and commercial success for andexanet alfa and Portola's
other 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; 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, which was filed on March 2,
2015, and Quarterly Report on Form 10-Q, which was filed
on August 5, 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
Portola Pharmaceuticals (NASDAQ:PTLA)
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