8/28/2012 10:57:04 AM
MUNICH and CALGARY, Aug. 28, 2012 /PRNewswire/ - Resverlogix Corp. (TSX: RVX)
today announced that the BET protein inhibitor RVX-208 significantly
increased HDL-C (p=0.001), the primary endpoint of the SUSTAIN trial, a
phase 2b clinical study. SUSTAIN also successfully met secondary
endpoints, showed increases in levels of Apo-AI (p=0.002) and large HDL
particles (p=0.02), both believed to be important factors in enhancing
reverse cholesterol transport activity. The SUSTAIN trial also showed
that increases in alanine aminotransferase (ALT) reported in previous
trials were infrequent and transient with no new increases observed
beyond week 12 of the 24-week trial.
The SUSTAIN trial was directed by a clinical steering committee chaired
by Dr. Steven Nissen with Dr. Stephen Nicholls serving as Principal
Investigator. The committee has approved release of topline findings
pending submission of full trial results for publication in a
peer-reviewed medical journal.
"Successful completion of the SUSTAIN trial provides Resverlogix with
important data regarding improvement in the functionality of the HDL
produced by RVX-208," stated Donald McCaffrey, president and chief
executive officer of Resverlogix. "Safety data from SUSTAIN reconfirm
our belief that early liver signals witnessed in this and previous
trials were of a transient nature," Mr. McCaffrey added. "The data
support that RVX-208 is suitable for chronic use. The value of this
knowledge will benefit our entire epigenetic and bromodomain research
program by showing safe versions of epigenetic regulating molecules are
indeed achievable. We believe that based on the collective knowledge
gained from our recent trials, our company is well positioned as we
approach the key plaque regression data expected in our ongoing ASSURE
trial."
The phase 2b SUSTAIN trial was conducted in South Africa and led by
investigators at the Cleveland Clinic. The study enrolled 176 patients
with established atherosclerotic cardiovascular disease (CVD) and low
high-density cholesterol (HDL-C). The primary purpose of the SUSTAIN
trial was to measure changes in HDL, Apo-AI and other lipid parameters
compared with placebo, while also assessing safety over an extended
treatment period in the patient population with the largest response to
RVX-208 in the phase 2 ASSERT trial. The increase in HDL and Apo-AI
observed in the 24-week SUSTAIN trial represents a notable increase
over the respective HDL and Apo-AI values reported in the 12-week
ASSERT trial.
Epigenetics
Epigenetics is the study of processes that enable information encoded in
DNA to be expressed. Although DNA encodes the genes, by itself DNA
cannot use this data. To use the data within DNA, it must work in
concert with proteins. An essential aspect in this collaborative
process is that both DNA and proteins are packaged together into
chromosomes that reside within the cell's nucleus. There are thousands
of different genes encoded within DNA, and, to enable expression of
these genes when called upon by the cell requires epigenetic
processes. One of the key epigenetic processes involves modification of
chromosomal proteins by acetylation, methylation or phosphorylation,
each of which is regulated by specific enzymes. These modified entities
serve as bait for other proteins, including BET proteins, to bind to,
or "read," these modifications ("the epigenetic code"). As the BET
proteins bind, they recruit additional proteins to regulate gene
activity. When the gene becomes active, it leads to synthesis of
messenger ribonucleic acid (mRNA) followed by translation of mRNA into
a specific protein. In the past decade, progress has been made in
understanding the role of epigenetics in human disease. This in-depth
understanding has led to the development of medicines directed toward
cancer, such as DNA methylation inhibitors and HDAC inhibitors. The
discovery that RVX-208 is a BET bromodomain inhibitor adds new momentum
to the promise of epigenetic mechanisms as a rich source of new
medicines.
About RVX-208
RVX-208 is a first-in-class, small molecule that inhibits BET
bromodomains. It is currently in clinical study for the treatment of
atherosclerosis. 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
ApoA-I, the key building block of functional high-density lipoprotein (HDL) particles and the type required for RCT.
Because they are newly produced, these functional HDL particles are
flat and empty and can efficiently remove plaque and stabilize or
reverse atherosclerotic disease. RVX-208 is currently being evaluated
in phase 2b studies for its ability to reverse and/or stabilize
atherosclerotic disease. The drug candidate also has the potential to
treat other indications, including neurodegenerative disorders.
About Resverlogix
Resverlogix Corp. (TSX: RVX) 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. New compounds arising from
Resverlogix's epigenetic drug discovery platform function by inhibiting
BET bromodomains and have the potential to impact multiple diseases
including cancer, autoimmune and neurodegenerative disorders.
Resverlogix'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 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. For further information, please contact: | Company Contacts: |
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Donald J. McCaffrey
President and CEO
Resverlogix Corp.
Phone: 403-254-9252
Email: don@resverlogix.com |
Sarah Zapotichny
Director of Investor Relations
Resverlogix Corp.
Phone: 403-254-9252
Email: sarah@resverlogix.com | |
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| | US Institutional Investors: | Media: | |
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Susan Noonan
Managing Partner
S.A. Noonan Communications, LLC
Phone: 212-966-3650
Email: susan@sanoonan.com
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Matt Middleman, M.D.
Russo Partners, LLC
Phone: 212-845-4272
Email: matt.middleman@russopartnersllc.com | |
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SOURCE Resverlogix Corp.
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