A data review by the independent Data Safety
Monitoring Board resulted in a recommendation for the BETonMACE
trial to continue as planned without any modification.
CALGARY, June 28, 2017 /CNW/ - Resverlogix Corp.
("Resverlogix" or the "Company") (TSX:RVX) today announced
that the independent Data and Safety Monitoring Board (DSMB)
for the Company's Phase 3 BETonMACE trial in high-risk
cardiovascular disease (CVD) patients has completed a fourth
planned safety review and recommended that the study should
continue as planned without any modifications. The DSMB reviewed
available study data and noted that no safety or efficacy concerns
were identified, and will conduct additional periodic reviews.
Resverlogix, the clinical steering committee, and all investigators
remain blinded to the trial data.
"The BETonMACE Phase 3 trial now has approximately
1,600 patients enrolled, representing approximately 67 percent of
total planned enrollment. Since the trial commenced in November,
2015, we now have patients that have been on treatment with
apabetalone for over 76 weeks, more than three times longer than
any treatment duration in any of the Company's previous Phase 2
trials. This recommendation confirms that apabetalone continues to
be safe and well-tolerated and with the addition of clinics in
Taiwan and Russia, we remain on track for full enrollment
by the fall of 2017" stated Dr. Michael
Sweeney, M.D., Senior Vice President of Clinical
Development.
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
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
Or visit our website: www.resverlogix.com
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 use of net proceeds from the offerings,
and the potential role of apabetalone in the treatment of CVD, DM,
chronic kidney disease, end-stage renal disease treated with
hemodialysis, neurodegenerative disease, Fabry disease, and 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
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.