Resverlogix Commences Dosing in ASSURE a Phase 2b IVUS Clinical Trial Targeting High-Risk Cardiovascular Disease Patients
TSX Exchange Symbol: RVX
CALGARY, Nov. 2, 2011 /PRNewswire/ – Resverlogix Corp. (“Resverlogix” or the
“Company”) (TSX:RVX) announced today the commencement of dosing in
ASSURE, a Phase 2b clinical trial led by the Cleveland Clinic. ASSURE
is a 26-week, multi-center, double-blind, randomized, parallel group,
placebo-controlled clinical trial that will assess coronary
atherosclerotic plaque changes in response to Resverlogix’s lead drug
RVX-208 using intravascular ultrasound (IVUS). ASSURE will examine the
early effects of RVX-208 induced ApoA-I production on atherosclerotic
plaque regression in the setting of patients with coronary artery
disease who have a low level of high-density lipoprotein cholesterol
(HDL-C). A total of 310 patients are expected to participate in ASSURE
of which 77 will receive placebo and 233 will be given 100 mg twice
daily of RVX-208.
An IVUS measurement will be taken prior to the first dose of RVX-208 and
this will be repeated after 26 weeks of treatment. The primary trial
endpoint will be IVUS measurement of a change in percent atheroma
volume from baseline to 26 weeks. Secondary objectives for ASSURE are:
(i) safety and tolerability of RVX-208 as reflected by adverse events,
and (ii) effects of RVX-208 on HDL and non-HDL lipid parameters.
“We are very pleased to have dosed our first patient in the ASSURE
clinical trial,” stated Donald J. McCaffrey, President & Chief
Executive Officer of Resverlogix. “Over the past two weeks we have seen
substantial advancements in the enrollment progress for the ASSURE
trial. Our initial two sites were activated in late September however
most of our 53 regulatory approved sites have come on line in the past
week and we expect the remaining 9 sites to be activated this month.
The enrollment procedure of ASSURE is to first screen the patients.
Should they meet the protocol inclusion criteria, they are then entered
into the trial and will be eligible for dosing two weeks after their
screen acceptance. We expect screening to proceed forward at a rapid
pace, and once all patients have been enrolled we will update the
market,” McCaffrey added.
RVX-208 is a novel small molecule that stimulates endogenous ApoA-I
production to trigger the synthesis of HDL. The use of this approach
will enhance the functionality of HDL. ApoA-I is the major protein
component of HDL. The main role of these particles is to act as the
body’s natural defense system against atherosclerosis by mediating a
normal physiologic process called reverse cholesterol transport (RCT).
This pathway enables cholesterol, including that within atherosclerotic
plaques of vessel walls, to be transported to the liver for further
processing and elimination from the body. Enhanced RCT clearance of
cholesterol from vessel walls should reduce or prevent atherosclerosis.
The ability of RVX-208 to increase ApoA-I production and thereby
augment RCT differentiates it from other HDL therapies. RVX-208 is
positioned to be one of the most promising drugs in development for the
treatment of atherosclerosis.
About Resverlogix Corp.
Resverlogix Corp. is a leading biotechnology company engaged in the
development of novel therapies for important global medical markets
with significant unmet medical needs. The NexVas(TM) Plaque Regression
program is the Company’s primary focus which is to develop novel small
molecules that enhance ApoA-I production. These vital therapies are
focused to address the burden of atherosclerosis and other important
diseases such as Acute Coronary Syndrome, Alzheimer’s disease,
Peripheral Artery Disease and Autoimmune diseases. Resverlogix Corp.’s
common shares trade on the Toronto Stock Exchange (TSX:RVX). For
further information please visit www.resverlogix.com.
This news release may contain certain forward-looking information as
defined under applicable Canadian securities legislation, that are not
based on historical fact, including without limitation statements
containing the words “believes”, “anticipates”, “plans”, “intends”,
“will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and
other similar expressions. In particular, this news release includes
forward looking information relating to research and development
activities, the conduct of the ASSURE trial and the potential role of
RVX-208 in the treatment of atherosclerosis. Our actual results, events
or developments could be materially different from those expressed or
implied by these forward-looking statements. We can give no assurance
that any of the events or expectations will occur or be realized. By
their nature, forward-looking statements are subject to numerous
assumptions and risk factors including but not limited to those
associated with the success of research and development programs,
clinical trial programs including possible delays in patient
recruitment, the regulatory approval process, competition, securing and
maintaining corporate alliances, market acceptance of the Company’s
products, the availability of government and insurance reimbursements
for the Company’s products, the strength of intellectual property,
financing capability, the potential dilutive effects of any financing,
reliance on subcontractors and key personnel and additional assumptions
and risk factors discussed in our Annual Information Form and most
recent MD&A which are incorporated herein by reference and are
available through SEDAR at www.sedar.com. The forward-looking statements contained in this news release are
expressly qualified by this cautionary statement and are made as of the
date hereof. The Company disclaims any intention and has no obligation
or responsibility, except as required by law, to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
SOURCE Resverlogix Corp.