Resverlogix Highlights Key Accomplishments and 2018 Targets
February 08 2018 - 7:00AM
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX)
highlighted today recent key accomplishments and 2018 targets.
Recent Accomplishments
The Company has recently achieved several major
accomplishments:
1) The Company received the U.S. Food and Drug
Administration (“FDA”) acceptance of its Phase 3 BETonMACE clinical
trial protocol;2) The U.S. will be the 15th country participating
in BETonMACE;3) In excess of 95% of the approximately 2,400
patients outlined in the Phase 3 BETonMACE clinical trial’s
protocol have been enrolled;4) The Company also received the
acceptance of the FDA of its application to commence a Phase 2a
Kidney Dialysis trial;5) The Company raised in excess of $100
million of additional capital and repaid its loan in
full;6) The Company has no outstanding debt.
In early 2018, the Company entered into a
licencing agreement with Medison Pharma Ltd. for the Company’s lead
therapeutic candidate, apabetalone (RVX-208), in Israel and the
Palestine Authority.
2018 Targets
For 2018, the Company targets commencing
enrollment of US-based patients in its Phase 3 BETonMACE trial in
the first half of 2018, conducting a Sample Size Reestimation
Analysis by approximately mid-2018, completing enrollment in
BETonMACE by the second quarter of 2018 based on the currently
targeted 2,400 patients, and having top-line data around the end of
2018. Furthermore, the Company targets randomizing its first
patient in its Phase 2a Kidney Dialysis clinical trial and
enrolling its first patient in its Fabry Disease clinical trial
during the second quarter of 2018.
The Company intends to raise additional capital
during and following the first quarter of 2018 to fund operations
and strengthen its financial position. The Company also intends to
pursue additional licensing opportunities, some of which are
expected to contain up front payments.
Donald J. McCaffrey, President and Chief
Executive Officer, stated, “We are very pleased with the
considerable progress and achievements we’ve made during the last
year and are working diligently on achieving our targets for the
current year. With top-line data expected to be available around
year-end, this remains a very exciting and pivotal time for
Resverlogix and its shareholders.”
Remedial Delisting Review
As previously reported, as a result of the
Company’s reliance upon the financial hardship exemption in
connection with the Company’s previously-announced $87 million
private placement with Shenzhen Hepalink Pharmaceutical Co. Ltd.,
the TSX commenced an automatic remedial de-listing review, which is
normal practice when a listed issuer relies on this exemption. The
Company anticipates further improving its financial position by
raising additional capital. The Company has received a 60-day
extension to April 12, 2018 for the TSX’s review of the Company’s
compliance with all of the TSX listing requirements.
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
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 timing of significant
milestones for the Phase 3 BETonMACE clinical trial, Phase 2a
kidney dialysis clinical trial and Fabry Disease clinical trial,
the Company’s intention to raise additional capital and pursue
licensing opportunities, 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, 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 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.
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