Portola Announces Oral Presentation of Phase 2 Data on PRT4445, Factor Xa Inhibitor Antidote, at 2013 International Society o...
26 Juin 2013 - 2:00PM
Marketwired
Portola Pharmaceuticals, Inc. (NASDAQ: PTLA) today announced that
safety and pharmacodynamic data from a Phase 2 trial of its
investigational Factor Xa inhibitor antidote PRT4445 in healthy
volunteers who were administered the Factor Xa inhibitor Eliquis®
(apixaban) will be presented in an oral session at the upcoming
XXIV Congress of the International Society on Thrombosis and
Haemostasis (ISTH), which is taking place in Amsterdam from June
29-July 4.
Details of the oral presentation follow:
Abstract title: A Phase 2 randomized,
double-blind, placebo-controlled trial of PRT4445, a novel,
universal antidote for direct and indirect Factor Xa inhibitors
Session: Abstract symposium: New developments
in treatment of venous thrombosis Presentation
date/time: Tuesday, July 2, 1:30-1:45 CET Location: Elicium 2 Presenter:
Mark Crowther, M.D., M.Sc., FRCPC, professor in the Department of
Medicine, Hematology and Thromboembolism, McMaster University,
Hamilton, Ontario
PRT4445, which has a tentatively approved International
Nonproprietary Name (INN) of 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. 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. Portola
entered into a collaboration agreement with Bristol-Myers Squibb
Company and Pfizer Inc. to study andexanet alfa with Eliquis® in
the Phase 2 study. Portola retains full, worldwide commercial
rights with respect to andexanet alfa.
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. and with Bayer Pharma
AG and Janssen Pharmaceuticals, Inc., to study andexanet alfa with
Eliquis® (apixaban) and XARELTO® (rivaroxaban), 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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