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Resverlogix's BET Protein Inhibitor RVX-208 Meets Primary Endpoint in SUSTAIN Clinical Trial in Patients With High Risk Cardiovascular Disease

Geschrieben am 28-08-2012

Munich And Calgary, Alberta (ots/PRNewswire) -

-- Significant Increase in Functional HDL Persisted Throughout
the 24-week Study Period --

-- Results from ASSURE Study Expected H1 2013, Using IVUS to
Measure Regression of Atherosclerotic Plaque --

TSX Exchange Symbol: RVX

Resverlogix Corp. 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. 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 . For further information please visit
http://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 http://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:
Donald J. McCaffrey
President and CEO
Resverlogix Corp.
Phone: +1-403-254-9252
Email: don@resverlogix.com
Sarah Zapotichny
Director of Investor Relations
Resverlogix Corp.
Phone: +1-403-254-9252
Email: sarah@resverlogix.com
US Institutional Investors:
Susan Noonan
Managing Partner
S.A. Noonan Communications, LLC
Phone: +1-212-966-3650
Email: susan@sanoonan.com
Media:
Matt Middleman, M.D.
Russo Partners, LLC
Phone: +1-212-845-4272
Email: matt.middleman@russopartnersllc.com

ots Originaltext: Resverlogix Corp.
Im Internet recherchierbar: http://www.presseportal.de


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