RVX-208 Reduces Major Adverse Cardiovascular Events (MACE) Significantly in Patients with Diabetes Mellitus

Calgary, Alberta (ots/PRNewswire) -

In addition, preliminary results from an Australian sponsored
trial have yet to verify whether the mechanism of RVX-208 action may
affect glucose metabolism.

Resverlogix Corp. announced today findings from the recent
analysis of Major Adverse Cardiovascular Events (MACE) data in
patients with diabetes mellitus (DM) enrolled in both the ASSURE and
SUSTAIN trials. In ASSURE, MACE was a pre-specified endpoint and it
was confirmed to be statistically and significantly reduced in
patients with DM treated with RVX-208 vs. placebo. The latest finding
reinforces the potential benefit of RVX-208, a first in class
BET-inhibitor, to impact MACE and additional metabolic parameters
over a duration of 6 months in high risk vascular patients with DM
and low HDL.

ASSURE enrolled a population who had high cardiovascular risk with
low HDL-C and amongst these almost 100 patients had DM. Approximately
75% (precise numbers here and below are reserved for future
publications and abstracts) of these patients with DM were given
RVX-208 while the remainder received placebo. Unexpectedly, we noted
a statistically significant relative risk reduction in MACE of more
than 65% in patients with DM treated with RVX-208 vs. placebo. While
this marked and significant reduction of MACE in the ASSURE data
alone is already very important, it is further supported by the
analysis of data from SUSTAIN, a trial with a population almost
identical to that in ASSURE. When data from both ASSURE and SUSTAIN
were pooled, patients with a history of DM totaled almost 200.
Roughly 2/3 of these patients received RVX-208 while the remainder
were given placebo. Analysis of the pooled patient data showed again
that RVX-208 treatment led to a statistically significant relative
risk reduction in MACE of >65% vs. placebo. In patients with DM,
RVX-208's ability to reduce MACE is very important because the
majority of the patients die from cardiovascular diseases.

In the ongoing analysis of pooled ASSURE and SUSTAIN data, many
biomarkers of cardiovascular risk were examined but the above
findings made blood glucose levels of specific interest. Results of
analysis showed that patients with DM given RVX-208 tended to have
lower blood glucose vs. placebo. But specifically in patients with DM
who had low HDL, the blood glucose was significantly lower following
treatment with RVX-208 vs. placebo. Furthermore, the time required
for RVX-208 to reduce blood glucose was not observed until at least
12 weeks following initiation of treatment.

While the analyses of ASSURE data was being conducted, a new trial
looking at metabolic parameters was in progress conducted at the
Baker IDI Heart and Diabetes Institute (Melbourne, Australia). The
investigators postulated that the RVX-208 induced rise in
ApoA-I/HDL-C may impact pancreatic insulin secretion and thereby
lower blood glucose (detected using an oral glucose tolerance test).
Patients (n=23) with pre-diabetes mellitus (also called metabolic
syndrome) were enrolled in the study and given 200 mg/day RVX-208 for
a short duration of only 4 weeks. The preliminary results were not
consistent with their hypothesis. However, this finding was useful in
understanding the ASSURE data because for RVX-208 to reduce blood
glucose in patients with DM required at least 12 weeks of treatment.
Analysis of data from the new trial beyond preliminary results
reported here will include; HDL abundance, lipidomics, platelet
aggregation, monocyte activation and neutrophil adhesion. Resverlogix
is planning to submit the above important findings and other new data
to scientific journals for peer review prior to publication and
presentation at leading medical conferences.

"Resverlogix will continue to examine in detail the data from its
numerous human clinical trials specifically for important biomarkers
that may play a role in high risk vascular diseases such as acute
coronary syndrome, type 2 diabetes mellitus and chronic kidney
disease" stated Donald McCaffrey, President and Chief Executive
Officer of Resverlogix. "These are new and important findings that
RVX-208, when added to standard of care medicine, reduces MACE in
patients with DM" added McCaffrey.

"The new observations above and continued analysis of our
extensive database are very important for establishing the emerging
role of BET inhibition in high risk vascular disease and especially
in those with DM" stated Dr. Jan Johansson, Senior Vice President of
Medical Affairs at Resverlogix. "The new information that we have
gained was essential in designing the next RVX-208 clinical trial to
facilitate product registration" Dr. Johansson further commented.

About Diabetes Mellitus & Glucose

Diabetes mellitus is a group of metabolic diseases in which a
patient's blood glucose is high. Untreated DM is a leading risk
factor for heart disease, kidney failure, loss of nerve function,
amputations and damage to the eyes. A primary defect in DM is the
inability of the pancreas to provide enough insulin for the body or
ineffective actions of insulin, thus leading to increased blood
glucose.

About RVX-208

RVX-208 is a first-in-class small molecule that selectively
inhibits BET bromodomains. RVX-208 functions via several mechanisms
such as 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. Analysis of recent clinical trials data showed that RVX-208
significantly reduces coronary atherosclerosis and major adverse
cardiac events in patients with CVD who have a low level of HDL and
elevated CRP, a population with unmet medical need. ApoA-I
enhancement and glucose lowering have been reported to exert
beneficial effects in Alzheimer's disease and Diabetes Mellitus.
RVX-208 also has anti-inflammatory effects including effects on
Interleukin-6 inhibition, vascular cell adhesion-1 and monocyte
chemotactic protein-1, factors known to be involved in
atherosclerosis and plaque stability.

About Resverlogix

Resverlogix Corp. is a clinical stage cardiovascular company
developing compounds involving a therapeutic increase in ApoA-I.
Resverlogix's RVX-208 is a first-in-class small molecule for the
treatment of atherosclerosis and other chronic diseases such as
Diabetes Mellitus and Alzheimer's disease. RVX-208 is the first BET
bromodomain inhibitor in clinical trials. 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 and other chronic diseases. 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:
Company Contacts:

Donald J. McCaffrey
President and CEO
Resverlogix Corp.
Phone: +1-403-254-9252
Email: don@resverlogix.com

Kenneth Lebioda
SVP Business & Corporate Development
Resverlogix Corp.
Phone: +1-403-254-9252
Email: ken@resverlogix.com

ots Originaltext: Resverlogix Corp.
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