Protocol comments and recommendations
incorporated
CALGARY, Feb. 23, 2017 /CNW/ - Resverlogix Corp.
("Resverlogix" or the "Company") (TSX: RVX) today announced the
receipt of the final minutes of an in-person Type B meeting with
the Cardiovascular and Renal Products Division of the U.S. Food and
Drug Administration (FDA). The purpose of the meeting was to
request written comments, recommendations and feedback on
Resverlogix's proposed protocol for its Phase 2a kidney dialysis
trial. The primary objective of the study will be to evaluate
if treatment with apabetalone in combination with standard of care
(SoC) decreases alkaline phosphatase in comparison to placebo and
SoC.
In light of guidance received from the FDA, the Phase 2a study
design will be separated in two parts. Part A will involve a
single-dose pharmacokinetic (PK) study in eight patients receiving
hemodialysis. The PK results from Part A will influence the dose
selection for Part B. Part B will be a double-blind, randomized,
placebo-controlled, sequential cross-over study with apabetalone,
and is designed to evaluate biomarker changes and safety parameters
with apabetalone in up to 30 patients with end-stage renal disease
treated with hemodialysis. Resverlogix intends to file an official
Investigative New Drug (IND) application and proceed with the
planned Phase 2a clinical trial in 2017.
About Advanced CKD & Dialysis
Advanced Chronic Kidney Disease (CKD) encompasses CKD stages 4
& 5, and it can be alternatively defined as an estimated
glomerular filtration rate (eGFR) of <30 ml/min/1.73m2. Reported
in the 2016 United States Renal Data System (USRDS) Annual Report,
approximately 1.4 million patients in the US have advanced CKD,
474,000 of which are on dialysis treatment. According to the USRDS,
advanced CKD cost the US healthcare system approximately
US$17 billion in 2014, with an
average cost exceeding US$28,000 per
patient. Additionally, dialysis treatment costs the US Medicare
system approximately US$28 billion
with an average cost exceeding US$80,000 per year. Currently there are no
known agents that improve major adverse cardiovascular events
(MACE) in CKD or dialysis 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, dialysis, Alzheimer's
disease, Orphan diseases, and peripheral artery disease, while
maintaining a well described safety profile. Apabetalone is the
only selective BET bromodomain inhibitor in human clinical trials,
currently in a Phase 3 trial BETonMACE in high-risk CVD patients
with type 2 DM and low high-density lipoprotein (HDL).
Resverlogix common shares trade on the Toronto Stock Exchange
(TSX: RVX).
For further information please
visit www.resverlogix.com.
Follow us on Twitter:
@Resverlogix_RVX (https://twitter.com/resverlogix_rvx), or on
our blog at http://www.resverlogix.com/blog
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
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 Company's Phase 2a kidney
dialysis trial and Phase 3 clinical trial, and the
potential role of apabetalone in the treatment of CVD, DM, chronic
kidney disease, Alzheimer's disease, Orphan diseases, and
peripheral artery disease. 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 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.
SOURCE Resverlogix Corp.