Resverlogix Completes Dosing in ASSURE Clinical Trial
Geschrieben am 18-04-2013 |
Calgary, Alberta (ots/PRNewswire) -
IVUS data will evaluate plaque regression in patients with
high-risk Cardiovascular Disease
TSX Exchange Symbol: RVX
Resverlogix Corp. today announced that it has completed dosing in
ASSURE, a Phase 2b clinical trial evaluating RVX-208, Resverlogix's
first-in-class orally active BET-protein inhibitor, using
intra-vascular ultrasound (IVUS) in high-risk cardiovascular patients
with low HDL and ApoA-I (n=324). These target patients have
significant residual risk in major adverse coronary events (MACE)
such as heart attack, unstable angina, stroke, revascularization and
death, despite standard of care therapy such as statins. The main
underlying cause of the residual risk in these patients is
atherosclerosis. ASSURE is designed to evaluate the ability of
RVX-208 to regress atherosclerotic disease.
"Atherosclerosis regression represents a new paradigm in the
treatment of high-risk cardiovascular disease patients," said Donald
McCaffrey, president and chief executive officer of Resverlogix. "The
completion of the ASSURE trial is a major development milestone for
the company. RVX-208 is the first small molecule BET inhibitor that
raises the production of ApoA-I to be tested in a landmark IVUS
trial."
ASSURE is a 26-week, multi-center, double-blind, randomized,
parallel group, placebo-controlled trial led by the Cleveland Clinic.
To assess atherosclerosis regression in ASSURE, all subjects were
examined using IVUS. The primary endpoint in ASSURE is to detect a
change in percent atheroma volume as determined by IVUS at baseline
vs. 26 weeks of treatment. The use of IVUS technology will provide
details regarding plaque composition and stability, which is
important because both are elements leading to acute coronary
syndrome. Secondary endpoints for ASSURE include safety and
tolerability of RVX-208, effects of the compound on plasma ApoA-I,
HDL-C, HDL-subclasses and non-HDL lipid parameters such as the CRP
inflammation marker. Top line data is expected mid-2013.
About RVX-208
RVX-208 is a first-in-class small molecule that inhibits BET
bromodomains. RVX-208 functions by removing atherosclerotic plaque
via reverse cholesterol transport (RCT), the natural process through
which atherosclerotic plaque is transported out of the arteries and
removed from the body by the liver. RVX-208 increases production of
Apolipoprotein A-I (ApoA-I), the key building block of functional
high-density lipoprotein (HDL) particles and the type required for
RCT. These newly produced, functional HDL particles are flat and
empty and can efficiently remove plaque and stabilize or reverse
atherosclerotic disease.
About Resverlogix
Resverlogix Corp. is a clinical stage cardiovascular company with
an epigenetic platform technology that modulates protein production.
Resverlogix is developing RVX-208, a first-in-class small molecule
for the treatment of atherosclerosis. RVX-208 is the first BET
bromodomain inhibitor in clinical trials. This drug also has the
potential to treat other indications, including diabetes mellitus,
and neurodegenerative disorders. New compounds arising from
Resverlogix's epigenetic drug discovery platform function by
inhibiting BET bromodomains and have the potential to impact multiple
therapeutic indications including cancer and autoimmune diseases.
Resverlogix's common shares trade on the Toronto Stock Exchange . For
further information please visit http://www.resverlogix.com. We can
be followed on our blog at http://www.resverlogix.com/blog
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 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 de.newsaktuell.mb.nitf.xml.Em@122d51ce. 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.
For further information, please contact:
Company Contacts: Donald J. McCaffrey President and CEO
Resverlogix Corp. Phone: +1-403-254-9252 Email: don@resverlogix.com
US Institutional Investors: Susan Noonan
Managing Partner S.A. Noonan Communications, LLC Phone:
+1-212-966-3650 Email: susan@sanoonan.com Sarah Zapotichny
Director of Investor Relations Resverlogix Corp. Phone:
+1-403-254-9252 Email: sarah@resverlogix.com Media: Matt
Middleman, M.D. Russo Partners, LLC Phone: +1-212-845-4272 Email:
matt.middleman@russopartnersllc.com
ots Originaltext: Resverlogix Corp.
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