Portola to Initiate Phase 2 Study Evaluating the Safety and Effectiveness of Its Factor Xa Inhibitor Antidote PRT4445 in Reve...
26 Juin 2013 - 10:00PM
Marketwired
Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) today announced that
it has entered into a clinical collaboration agreement with Daiichi
Sankyo Company, Limited to conduct a Phase 2 study evaluating the
safety and effectiveness of its investigational Factor Xa inhibitor
antidote PRT4445 at several different doses to reverse the
anticoagulant effects of Daiichi Sankyo's investigational oral,
once-daily, direct Factor Xa inhibitor edoxaban in healthy
volunteers. PRT4445 has a tentatively approved International
Nonproprietary Name (INN) of andexanet alfa.
Andexanet alfa is a recombinant protein designed to reverse the
anticoagulant activity in patients treated with a Factor Xa
inhibitor who suffer an uncontrolled bleeding episode or undergo
emergency surgery. Edoxaban is an investigational anticoagulant
that specifically and reversibly inhibits Factor Xa, an important
factor in the coagulation system that leads to blood clotting.
The collaboration will be in effect throughout the Phase 2
study, for which Daiichi Sankyo will provide development and
regulatory guidance. Portola retains all global development and
commercialization rights for andexanet alfa. Daiichi will make an
undisclosed cash payment to Portola upon initiation of the edoxaban
study.
Clinical trial results suggest that patients treated with novel
oral anticoagulants may experience uncontrolled bleeding (annually
between 1 and 4 percent) and some may require emergency surgery.
The lack of an effective reversal agent, or antidote, for patients
on Factor Xa inhibitors is an unmet need as currently there is no
such agent approved for use against Factor Xa inhibitors.
About Andexanet Alfa Andexanet alfa is a
novel recombinant protein designed to reverse the anticoagulant
activity in patients treated with a Factor Xa inhibitor who suffer
an uncontrolled bleeding episode or need to undergo emergency
surgery. Andexanet alfa is similar to native Factor Xa, but has
been modified to restrict its biological activity to the reversal
of the anticoagulant effects of Factor Xa inhibitors. Andexanet
alfa acts as a Factor Xa decoy that binds and sequestors direct
Factor Xa inhibitors in the blood. Once bound to andexanet alfa,
the Factor Xa inhibitors are unable to bind to and inhibit native
Factor Xa. The native Factor Xa is then available to participate in
the coagulation process and restore hemostasis.
Results from a Phase 1 single ascending dose safety and
tolerability study of andexanet alfa conducted by Portola in 32
healthy volunteers in the United States showed no apparent safety
signals, including no thrombotic adverse events.
About Portola Pharmaceuticals, Inc.
Portola is a biopharmaceutical company focused on the development
and commercialization of novel therapeutics in the areas of
thrombosis (blood clots), other hematologic disorders and
inflammation for patients who currently have limited or no approved
treatment options. Portola's current development-stage portfolio
consists of three compounds discovered through its internal
research efforts and one discovered by Portola scientists during
their time at a prior company. Portola's two lead programs address
significant unmet medical needs in the area of thrombosis.
Portola's lead compound, betrixaban, is an investigational,
novel, oral, once-daily inhibitor of Factor Xa in Phase 3
development for extended duration prophylaxis (preventive
treatment) of a form of thrombosis known as venous thromboembolism
(VTE) in acute medically ill patients. Currently, there is no
anticoagulant approved for extended duration VTE prophylaxis in
this population.
Portola's second lead development candidate, andexanet alfa, is
a recombinant protein designed to reverse the anticoagulant
activity in patients treated with a Factor Xa inhibitor who suffer
an uncontrolled bleeding episode or need to undergo emergency
surgery. Portola has entered into collaboration agreements with
Bristol-Myers Squibb Company and Pfizer Inc., with Bayer Pharma AG
and Janssen Pharmaceuticals, Inc., and with Daiichi Sankyo to study
andexanet alfa with Eliquis® (apixaban), XARELTO® (rivaroxaban) and
edoxaban, respectively, in Portola's Phase 2 studies. Portola
retains full, worldwide commercial rights with respect to andexanet
alfa.
Portola's third product candidate, PRT2070, is an orally
available kinase inhibitor being developed for hematologic (blood)
cancers and inflammatory disorders. PRT2070 inhibits spleen
tyrosine kinase (Syk) and janus kinases (JAK), enzymes that
regulate important signaling pathways. Subject to regulatory
approval, Portola plans to initiate a Phase 1/2 clinical study of
PRT2070 in 2013 in patients with B-cell hematologic cancers who
have failed or relapsed on existing marketed therapies or products
in development, including patients with identified mutations.
Portola's fourth program, PRT2607 and other highly selective Syk
inhibitors, is partnered with Biogen Idec Inc.
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 use of
betrixaban as a Factor Xa inhibitor, the use of PRT4445, which has
a tentatively approved International Nonproprietary Name (INN) of
andexanet alfa, to reverse the anticoagulant activity in patients
treated with a Factor Xa inhibitor, the use of PRT2070 or PRT2607
as kinase inhibitors and any of Portola's clinical trials,
including Portola's Phase 3 APEX study for betrixaban, Phase 2
proof-of-concept studies for PRT4445 and Phase1/2 study for
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
filings with the Securities and Exchange Commission, including
without limitation its Registration Statement on Form S-1 that was
originally filed with the Securities and Exchange Commission on
April 12, 2013, and the amendments thereto. 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.
Contacts: Mardi Dier CFO Portola Pharmaceuticals Email
Contact Paul Laland BrewLife Email Contact 415.946.1071
Portola Pharmaceuticals (NASDAQ:PTLA)
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