CALGARY, Alberta, June 1, 2015 /PRNewswire/ --
RVX-208, the first selective
bromodomain extra-terminal (BET) protein inhibitor, significantly
reduces alkaline phosphatase (ALP) levels in patients with high
vascular risk
Resverlogix Corp. (TSX: RVX) (the "Company") today announced
that new data on RVX-208 was presented at the ERA-EDTA
Congress in London, England in a
poster entitled: "Effects of RVX-208, a First-in-Class Epigenetic
BET-Inhibitor, on Key Renal Parameters in Subjects with a History
of CVD, and Chronic Kidney Disease (CKD); a Post-hoc Analysis of
Patients from the ASSERT, SUSTAIN and ASSURE Clinical Trials."
Dr. Kam Kalantar-Zadeh, Professor
and Chief, Division of Nephrology and Hypertension
at University of California in Irvine
and Los Angeles stated, "Selective
BET inhibition via RVX-208 may represent a novel approach to CKD
treatment. Analyses of the data from recent clinical trials suggest
that RVX-208 significantly lowers serum alkaline phosphatase (ALP)
and improves lipid parameters in patients with CKD. Together these
new findings warrant additional clinical trials for target
responder CKD and/or dialysis populations who have a high burden of
cardiovascular disease and risk." Dr. Kalantar-Zadeh examined the
data and contributed to this abstract at ERA-EDTA. He has also
contributed to additional abstracts that have been submitted for
peer review presentation.
In the pooled analysis from the SUSTAIN and ASSURE trials
(n=499), assessment of the metabolic biomarker ALP, revealed a
significant reduction of -10.98% in all RVX-208 treated patients
(n=331) compared to a reduction of -3.23% in placebo treated
patients (n=168) (p<0.0001) at the combined time points of 24
and 26 weeks. In addition, several subgroup analysis were
performed. In patients with a history of diabetes, a significant
reduction in ALP of -13.9% was observed in the RVX-208 treated
group (n=127) compared to -4.49% in the placebo treated group
(n=65) (p<0.0001). Further analysis was performed on patients
with Chronic Kidney Disease (CKD), defined by an estimated
glomerular filtration rate (eGFR) of below 60 mL/min/1.73
m2. In this group, RVX-208 treated patients (n=35) had
reduced ALP levels of -13.9% versus -6.28% in placebo (n=13)
(p=0.008). In addition, following 6 months of RVX-208 treatment, an
increase in eGFR of +3.4% (p=0.04 vs. baseline) in the RVX-208
treated group was observed compared to a decrease of -5.9% in the
placebo group.
More information on CKD can be found on our blog at:
http://www.resverlogix.com/blog/2015/05/28/resverlogix-our-interest-in-chronic-kidney-disease/
and
http://www.resverlogix.com/blog/2015/05/29/resverlogix-further-interest-in-chronic-kidney-disease/.
About RVX-208
RVX-208 is a first-in-class, small molecule selective BET
bromodomain inhibitor. BET bromodomain inhibition is an epigenetic
mechanism that can turn disease-causing genes off, returning them
to a healthier state. RVX-208 is the first and only BET inhibitor
selective for BRD4-BD2, producing a nexus of biological effects
with potentially important benefits for patients with diseases such
as cardiovascular disease (CVD), diabetes mellitus (DM),
Alzheimer's disease, peripheral artery disease, and chronic kidney
disease while maintaining an excellent safety profile. Resverlogix
is planning to study RVX-208 in a proposed Phase 3 clinical trial
in CVD patients with DM and low HDL.
About Resverlogix
Resverlogix Corp. is developing RVX-208, a first-in-class, small
molecule selective BET bromodomain inhibitor for the potential
treatment of patients with cardiovascular disease, diabetes
mellitus, Alzheimer's disease, peripheral artery disease, and
chronic kidney disease. RVX-208 is the only selective BET
bromodomain inhibitor in clinical trials. Resverlogix's common
shares trade on the Toronto Stock Exchange (TSX: RVX). For further
information please visit http://www.resverlogix.com. We can be
followed on our blog
at http://www.resverlogix.com/blog and via
Twitter https://twitter.com/resverlogix_rvx @Resverlogix_RVX.
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.
Company Contacts:
Donald J. McCaffrey
President and CEO
Resverlogix Corp.
Phone: +1-403-254-9252
Email: don@resverlogix.com
Kenneth Lebioda
Senior Vice President Business & Corporate Development
Resverlogix Corp.
Phone: +1-403-254-9252
Email: ken@resverlogix.com
Sarah Zapotichny
Director of Investor Relations & Corporate Communications
Resverlogix Corp.
Phone: +1-403-254-9252
Email: sarah@resverlogix.com