Resverlogix Receives FDA Protocol Acceptance for the Ongoing Phase 3 BETonMACE Trial
January 11 2018 - 9:33AM
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
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which are incorporated herein by reference and are available
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forward-looking statements contained in
this news release are expressly qualified by this
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responsibility, except as required by law, to update or revise any
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future events or otherwise.
For further information please
contact:
Investor Relations Email: ir@resverlogix.com Phone: 403-254-9252
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