CALGARY, Alberta, August 29, 2017 /PRNewswire/ --
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) is
pleased to announce that key findings from the recently completed
CANTOS trial, which demonstrate that targeting residual
inflammatory risk resulted in a reduction in the incidence of Major
Adverse Cardiovascular Events ("MACE"), validate the importance of
reducing inflammation as a therapeutic strategy for treating
Cardiovascular Disease ("CVD").
Novartis' Phase 3 CANTOS trial was designed to investigate the
efficacy, safety and tolerability of ACZ885 (canakinumab) in
combination with standard of care in people with a prior heart
attack and heightened inflammation. Similar to Resverlogix'
ongoing Phase 3 BETonMACE trial, the primary endpoint of the CANTOS
study was time to first occurrence of a narrowly defined 3-point
MACE, a composite of cardiovascular death, non-fatal myocardial
infarction, and non-fatal stroke.
As reported on the CardioBrief website, the CANTOS trial is
"being hailed by experts for finally validating the role of
inflammation in heart disease." CANTOS demonstrated the benefit of
targeted therapy, an evolving paradigm in medicine. Similarly,
treatment with Resverlogix' apabetalone has demonstrated a
reduction in the inflammatory mediator IL-6 by 29 percent and
positively modified the neutrophil/lymphocyte ratio, a well-known
marker of inflammation in cardiovascular patients, analogous to the
recent observations from CANTOS. This information is included in
the Resverlogix posters being presented at the European Society of
Cardioligists ("ESC") Congress 2017, as noted below, and available
on the Company website HERE. This data potentially explains
the MACE reduction results observed in Resverlogix's Phase 2
trials.
Mr. Donald McCaffrey, President
and CEO, stated, "The CANTOS trial is a major advancement in
proving that inflammation and not just lipids underlie
cardiovascular disease. This trial validates, for the first time,
that anti-inflammatory therapies can address the residual risk in
cardiovascular disease that exists despite intense lipid
management. Our lead drug, apabetalone, has marked effects on
reducing key inflammation markers such as CRP, IL6 and MCP1, and
other biological pathways important for innate immunity,
coagulation and calcification. In fact, Resverlogix's previous
Phase 2 broad MACE results in trials with apabetalone compare
favourably to the reported CANTOS results. For this reason, we
remain optimistic about and look forward to completion of
BETonMACE. Our Phase 3 trial will test for the first time, that by
modulating the multiple pathways underlying CVD, including
inflammation, by epigenetic modification, we can reduce MACE
outcomes in high risk patients."
Professor Kausik Ray, Imperial
College London, and Chairman of the BETonMACE Clinical Steering
Committee, commented, "the BETonMACE Phase 3 trial is designed to
test for a reduction in MACE in high risk CVD patients with
diabetes who have residual inflammatory risk (and much higher
absolute risk than patients in the CANTOS trial). Patients included
in BETonMACE are those with a recent heart attack and diabetes,
both of which result in a highly inflamed vasculature and the
CANTOS results are encouraging for the potential success of the
BETonMACE trial. Further, the BETonMACE population represent a huge
unmet medical need with a predicted annual CVD event rate of over 7
percent which compares to about 4.3 percent in the CANTOS
study."
Resverlogix Hosted Satellite Symposium at the ESC Congress
2017
The Company also announced today that on Saturday, August 26, 2017, it hosted a symposium
titled: "Managing Diabetes & CVD: Is epigenetics a new way
forward?" at the ESC Congress 2017.
The agenda and speakers were as follows:
Introduction
Lina Badimon, MD - Barcelona, Spain
Managing high risk diabetes patients with cardiovascular
disease: What works, and what else can we do?
- Kausik Ray, MD -
Imperial College London, United
Kingdom
Promise of epigenetic modulation as a target in
atherosclerotic patients
- Erik Stroes, MD - Academic
Medical Centre, Amsterdam,
Netherlands
Insights from the first trials in epigenetics in human: What
is the way forward?
- Stephen Nicholls, MD -
Adelaide, Australia
Presentations will be made available HERE.
Resverlogix also presented two posters at the congress
titled:
i) "Lowering the neutrophil to lymphocyte ratio
by the BET inhibitor, apabetalone: potential
implications for cardiovascular events in
high risk patients"
Poster Presentation Details:
Date: Sunday, August 27, 2017
Time: 9:30am - 10:45am CET
Session number: 302
Session title: Poster Session 2
ii) "Apabetalone (RVX-208) impacts key
biomarkers and pathways associated with
cardiovascular disease in patients with
severe renal impairment"
Poster Presentation Details:
Date: Tuesday, August 29, 2017
Time: 3:30pm - 4:30pm CET
Session number: 307
Session title: Poster Session 7
The posters are available HERE on the Company's
website.
About BETonMACE
To date:
- BETonMACE has successfully completed a total of 4 safety
reviews by the Data Safety Monitoring Board
- BETonMACE has over 1,750 patients enrolled, representing
approximately 75 percent of total planned enrollment.
In 2015, Resverlogix initiated a global Phase 3 clinical trial
called BETonMACE with apabetalone for the reduction of MACE in
high-risk CVD patients with type 2 diabetes mellitus and low
high-density lipoprotein (HDL). The primary endpoint is to evaluate
if treatment with apabetalone as compared to placebo increases time
to the first occurrence of a MACE, defined as a single composite
endpoint of: cardiovascular death, non-fatal myocardial infarction,
or stroke. Secondary endpoints include: revascularization and
unstable angina; changes in apolipoprotein A-I (apoA-I),
apolipoprotein B (apoB), low-density lipoprotein cholesterol
(LDL-C), high-density lipoprotein cholesterol (HDL-C), and
triglycerides (TG); changes in Hemoglobin A1c (HbA1c), fasting
glucose, and fasting insulin; and changes in alkaline phosphatase
(ALP) and estimated glomerular filtration rate (eGFR) in Stage 3
CKD patients.
About Resverlogix
Resverlogix is developing apabetalone (RVX-208), a
first-in-class, small molecule that is a selective BET (bromodomain
and extra-terminal) inhibitor. BET bromodomain inhibition is an
epigenetic mechanism that can regulate disease-causing genes.
Apabetalone is the first and only BET inhibitor selective for the
second bromodomain (BD2) within the BET protein called BRD4. This
selective inhibition of apabetalone on BD2 produces a specific set
of biological effects with potentially important benefits for
patients with high-risk cardiovascular disease (CVD), diabetes
mellitus (DM), chronic kidney disease, end-stage renal disease
treated with hemodialysis, neurodegenerative disease, Fabry
disease, peripheral artery disease and other orphan diseases, while
maintaining a well described safety profile. Apabetalone is the
only selective BET bromodomain inhibitor in human clinical trials.
Apabetalone is currently being studied in a Phase 3 trial,
BETonMACE, in high-risk CVD patients with type 2 DM and low
high-density lipoprotein (HDL), and is expected to be initiated in
a Phase 2a kidney dialysis trial designed to evaluate biomarker
changes and safety parameters in up to 30 patients with end-stage
renal disease treated with hemodialysis.
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).
Follow us on
Twitter: @Resverlogix_RVX (https://twitter.com/resverlogix_rvx),
or 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 the potential role of apabetalone in the
reduction of MACE outcomes in high risk patients and the treatment
of CVD, DM, chronic kidney disease, end-stage renal disease treated
with hemodialysis, neurodegenerative disease, Fabry disease,
peripheral artery disease and other orphan 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
those 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:
Investor Relations
Email: ir@resverlogix.com
Phone: +1-403-254-9252
Or visit our website: http://www.resverlogix.com