CALGARY, Alberta, July 10, 2017 /PRNewswire/ --
Resverlogix Corp. ("Resverlogix" or the
"Company") (TSX:RVX) today announced that the first patient
has been randomized in Taiwan in
the Phase 3 BETonMACE clinical trial with lead drug apabetalone
intended for high-risk patients with cardiovascular disease ("CVD")
and type 2 diabetes mellitus ("DM").
On July 8, 2015, Resverlogix and
Shenzhen Hepalink Pharmaceutical Co., Ltd. ("Hepalink") closed a
license agreement for China,
Hong Kong, Taiwan, and Macau (the "Territories"). Under the terms of
the agreement, Hepalink is responsible for certain clinical and
development costs in the Territories, for a Taiwan/China
patient population that is now being included in Resverlogix's
Phase 3 BETonMACE trial. As a result of the randomization, Hepalink
is now responsible for the first CAD$1
million payment to Resverlogix.
The license agreement also stipulates that when apabetalone
reaches certain annual sales milestones in the Territories, ranging
from 500 million renminbi ("RMB") to RMB 10
billion, Resverlogix will be eligible to receive sales-based
milestone payments from Hepalink, each ranging from USD$5 million to USD$90 million. In
addition, Hepalink will pay Resverlogix a royalty based on net
sales. Total sales based milestones and royalty payments have an
estimated potential in excess of USD$400
million. The license will expire on a region-by-region basis
on the later of the 15th anniversary of the first
commercial sale in such region or the expiry date of the
last-to-expire of any licensed patent.
Dr. Michael Sweeney, M.D., Senior
Vice President of Clinical Development stated, "With the assistance
of our partner in China, Hepalink,
we are pleased to announce the randomization of our first patient
in BETonMACE in Taiwan. Total
enrollment in the BETonMACE trial is now over 1,600 patients. With
the addition of new active clinics in the Territories, and soon in
the Netherlands and in
Russia, we remain on track for
full enrollment in the study by the fall of 2017."
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
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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 total sales based milestones and royalty
payments in the Territories from Hepalink, the attainment of
certain annual sales milestones of apabetalone in the Territories
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.
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: +1-403-254-9252
Or visit our website: www.resverlogix.com