Regado Biosciences, Inc. Presents the First Clinical Experience with REG2, its Second Product Candidate, at the Arteriosclerosis, Thrombosis and Vascular Biology Scientific Sessions in San Francisco, CA on April 9, 2010.
BASKING RIDGE, N.J., April 9 /PRNewswire/ -- Regado Biosciences,
Inc., a privately held company leading the development of
antithrombotic aptamers with active control agents, announced that
Steven Zelenkofske, DO, FACC, Senior Vice President, Chief Medical
Officer, presented an abstract at the Arteriosclerosis, Thrombosis
and Vascular Biology Scientific Sessions on April 9, 2010 at 5pm
(PST) in San Francisco, CA. The poster, entitled "Subcutaneous
RB006, a Direct FIXa Inhibitor Provides Prolonged Anticoagulation
with Rapid Reversal; the First Clinical Experience with the REG2
System" is the initial presentation of top-line data from Regado's
REG2-SC101 phase 1 study of the REG2 anticoagulation system. The
REG2 system is Regado's second product candidate in development,
which consists of a subcutaneously administered formulation of the
specific Factor IXa inhibitor, RB006, paired with an IV bolus
formulation of its complementary active control agent, RB007.
The abstract is coauthored by Christopher P. Rusconi, PhD,
Steven L. Zelenkofske, DO and Carolyn M. Darmiento, MS, from Regado
Biosciences, Richard Becker, MD, Duke University School of
Medicine, Durham, NC, William Wargin, PhD, PK-PM Consultants, and
Matthew Medlock, MD, PPD, Austin Texas. Dr. Zelenkofske stated:
"Because no prior human experience with a subcutaneous aptamer
exists, we were pleased that the REG2 system provided prolonged
anticoagulation after single injection with rapid reversibility.
This may provide a new approach to sub-acute anticoagulation for
future clinical applications." Dr. David J. Mazzo, Regado
Biosciences' CEO and President added: "Regado Biosciences has a
comprehensive antithrombotic pipeline which reflects the company's
expertise in the discovery and development of therapeutic aptamers
with active control agents in both arterial and venous thrombosis.
The data from our REG2-SC101 phase 1 study is encouraging and
supports our continued focus in venous thrombosis".
ABOUT REGADO BIOSCIENCES
Regado Biosciences is pioneering a new therapeutic technology
with the creation and development of two-component drug systems.
Each system comprises a nuclease-stabilized RNA aptamer that can be
controlled directly by its specific and complementary
oligonucleotide active control agent. This technology is being
applied to injectable antithrombotics (including anticoagulants and
antiplatelet agents) in the acute and sub-acute care setting, a
multi-billion dollar market in need of therapeutics with improved
safety profiles and a greater degree of therapeutic control.
Regado's technology is designed to give physicians the ability to
actively and directly control each system's therapeutic effect
providing a safe and unique approach to personalized
medicine.
ABOUT REG1 and REG2
Regado's lead program, the anticoagulant system REG1, consists
of two parenteral agents both administered by IV bolus, the first
being a potent highly selective Factor IXa inhibitor (RB006) and
the second being its complementary active control agent (RB007).
RB007 can be used to selectively completely or partially reverse
the anticoagulant effect of RB006. REG1, presently in phase 2b
clinical trial, is intended for application in arterial thrombosis
applications, initially in Acute Coronary Syndrome patients
undergoing Percutaneous Coronary Intervention. REG2, Regado's
second product candidate, consists of a subcutaneously administered
depot formulation of RB006 paired with the IV bolus formulation of
RB007. REG2 recently completed single escalating dose phase 1
clinical testing (the first successful subcutaneous application of
an aptamer in humans) and is planned to be studied in a multiple
escalating dose clinical trial later in 2010. It is intended for
use in venous thrombosis indications such as venous thromboembolism
(VTE) prophylaxis in patients undergoing abdominal surgery.
Information pertaining to Regado's clinical programs may be
obtained at www.clinicaltrials.gov.
ABOUT APTAMERS
RB006 is a member of a class of compounds called aptamers.
Aptamers are single stranded oligonucleotides that adopt a specific
conformation enabling direct, specific inhibition of the targeted
protein. A key unique feature of aptamers derives from the fact
that they are formed from nucleic acids. As such, their
pharmacologic activity can be controlled by a matched,
complementary oligonucleotide active control agent (the
Watson-Crick base pair complement of a fraction of the agent to be
controlled), which can bind to the aptamer, removing it from its
target and reversing it biologic effects.
More information can be found at www.regadobio.com
Source: Regado Biosciences, Inc.
CONTACT: Ellen McDonald, Chief Business Officer, Regado
Biosciences,
+1-908-580-2113, emcdonald@regadobio.com
Web Site: http://www.regadobio.com/
Posted: April 2010
