CALGARY, Alberta, Jan. 11, 2018 (GLOBE NEWSWIRE) --
Resverlogix Corp. (“Resverlogix” or the "Company") (TSX:RVX) and the Resverlogix BETonMACE Clinical Steering
Committee (CSC), represented by Professor Kausik Ray (Chair), are pleased to announce the FDA acceptance of the Company’s Phase 3
BETonMACE trial Protocol amendments.
On behalf of all members of the BETonMACE CSC, Professor Kausik Ray welcomed the addition of US-based sites to
the ongoing cardiovascular disease (CVD) outcomes trial, BETonMACE. The BETonMACE trial will now be expanded beyond Europe, Asia
and South America to a fourth continent – North America with the addition of the United States. Prof. Ray commented, “The addition
of the United States is timely as we plan to conduct a Sample Size Recalculation Analysis ('SSRA') later in the first half of 2018.
BETonMACE is currently targeted to include 2,400 participants to yield 250 MACE events and this number may be increased if
required. Enrolling patients from the major regions of the world will provide evidence of generalizability in different healthcare
systems and in different populations should apabetalone show improvement in cardiovascular outcomes. The FDA acceptance of the
BETonMACE trial in US centers is an important milestone in the development of this compound.”
Further, Mr. Donald McCaffrey, President and Chief Executive Officer, stated, "I am extremely pleased with the
continued progress of the BETonMACE trial. We have already enrolled over 2,200 patients and expanding territories and potentially
number of patients beyond 2,400 may be beneficial in several ways, scientifically and commercially. BETonMACE top line data is
still planned to be available around the end of 2018.”
About BETonMACE and the Clinical Steering Committee
The CSC is responsible for oversight and strategic direction for the Company’s Phase 3 BETonMACE trial. The
BETonMACE study, “Effect of RVX-208 on Time to Major Adverse Cardiovascular Events (MACE) in High-Risk Type 2 Diabetes Mellitus
Subjects with Coronary Artery Disease,” commenced in October 2015. The study is a large international multicenter, double-blind,
randomized, parallel group, placebo-controlled clinical trial to determine whether treatment with apabetalone in combination with
rosuvastatin or atorvastatin increases the time to MACE compared to treatment with rosuvastatin or atorvastatin alone. The primary
endpoint of the BETonMACE trial is designed to show a relative risk reduction of MACE, narrowly defined as a single composite
endpoint of cardiovascular death, non-fatal myocardial infarction (“MI”) and stroke. The study is an event-based trial and will
continue until at least 250 MACE events have occurred.
The study will ultimately contain at least 2,400 patients in 14 participating countries.
Members of the CSC include:
- Professor Kausik Ray (Chair), BSC (HONS), MBCHB, MD, MPHIL (CANTAB), FACC, FAHA, FESC, FRCP - Imperial College London,
London, UK.
- Dr. Henry N. Ginsberg, MD, FAHA - Columbia University College of Physicians and Surgeons, New York, NY.
- Dr. Kamyar Kalantar-Zadeh, MD, MPH, PHD, FAAP, FACP, FASN, FAHA, FNKF - UC Irvine School of Medicine, Irvine, CA.
- Professor Stephen J. Nicholls, MBBS, PHD - University of Adelaide, Adelaide, AUS.
- Dr. Gregory G. Schwartz, MD, PHD - University of Colorado, Denver, CO.
- Dr. Peter P. Toth, MD, PHD, FAAFP, FICA, FAHA, FNLA, FCCP, FACC - University of Illinois School of Medicine, Chicago, IL.;
Johns Hopkins University School of Medicine, Baltimore, MD.
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).
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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 the enrollment of US patients in BETonMACE, the estimated availability of top line
data from the BETonMACE clinical trial, the Company's Phase 3 clinical trial 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.
For further information please contact:
Investor Relations
Email: ir@resverlogix.com
Phone: 403-254-9252
Or visit our website: www.resverlogix.com