In addition, preliminary results from an Australian sponsored trial have
yet to verify whether the mechanism of RVX-208 action may affect
glucose metabolism.
TSX Exchange Symbol: RVX
CALGARY, July 23, 2014 /CNW/ - Resverlogix Corp. (TSX: RVX) 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. (TSX: RVX) 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 (TSX: RVX). For further information
please visit 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 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.
Company Contacts:
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Donald J. McCaffrey
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Kenneth Lebioda
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President and CEO
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SVP Business & Corporate Development
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Resverlogix Corp.
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Resverlogix Corp.
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Phone: 403-254-9252
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Phone: 403-254-9252
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Email: don@resverlogix.com
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Email: ken@resverlogix.com
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SOURCE Resverlogix Corp.