�Regado Biosciences, Inc.
announced the presentation of comprehensive results from Phase Ia, Ib
and Ic studies of the Company's REG1 Anticoagulation System at the European
Society of Cardiology's Congress 2008, currently existence held in Munich,
Germany. REG1 is a two-component system composed of an aptamer-based
anticoagulant, RB006, and its matched, active turn around agent, RB007, which
binds to and neutralizes RB006.
Results from the trey Phase I studies showed RB006 inhibited the
activity of factor IXa, a protein essential to blood clotting, and RB007
rapidly, safely and specifically converse the natural process of RB006. Results
from the Phase Ic study further support the potentiality for RB007 to turnaround
the anticoagulant medication effect of RB006 in a stratified fashion either completely or
partially, depending on the dose of RB007. Detailed findings included:
-- Escalating doses of RB006 achieved a dose-dependent increase in
pharmacodynamic body process in healthy subjects, prolonging the activated
partial thromboplastin time (aPTT), a step of the blood's ability to
clot.
-- This response too was seen in patients with stable coronary arterial blood vessel
disease, thereby confirming pharmacodynamic reproducibility in the
target area patient population.
-- Escalating doses of RB007 chop-chop achieved a dose-dependent decrease in
aPTT in patients previously dosed with RB006. Complete inhibition of
RB006 was shown within 15 minutes of administration of sufficient
doses of RB007.
-- No major haemorrhage, allergic or thrombotic events occurred in any of the
studies. The majority of events were minor bleeds at the venous access
situation. The incidence of additional minor events, including cephalalgia,
dizziness, nausea, fatigue and hypotension, was similar to placebo.
"Our studies systematically have confirmed the deuce major attributes of
the REG1 system, rapid anticoagulant medication activity and rapid and predictable
reversal of this effect," declared David J. Mazzo, Ph.D., President and Chief
Executive Officer of Regado Biosciences. "Based on the encouraging Phase I
study data, we foretell results from our ongoing Phase IIa studies
evaluating REG1 in
patients undergoing elective PCI will further confirm that REG1 has the
electric potential to replace standard heparin therapy."
"In striving to meet the needs of individual patients in varied and
ofttimes complex settings, it is essential for physicians to quickly,
safely and effectively achieve the desired anticoagulation effect and, when
required for specific clinical indications, to rarefy or fully reverse
this effect," stated Richard C. Becker, M.D., Professor of Medicine, Duke
University Medical Center, and Director, Duke Cardiovascular Thrombosis
Center, Duke Clinical Research Institute. "As we enter a new era of
anticoagulant pharmacotherapy, a therapeutic system offer these
attributes would be of great benefit and may have got a fundamental impact on
patient fear."
Clinician-scientists from the Duke Clinical Research Institute (DCRI)
and Regado evaluated REG1 in triplet Phase I studies: Phase Ia, a healthy
volunteer drug dose-escalating
