• 11.08.2016, 13:02:37
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  • OTE0003

Resverlogix Announces Positive Recommendation From Data Safety Monitoring Board for Phase 3 Study of Apabetalone (RVX-208)

Calgary, Alberta (ots/PRNewswire) - A data review by the independent
Data Safety Monitoring Board resulted in a verbal recommendation for
the BETonMACE trial to continue as planned without any modification.

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 (CVD) patients has completed a planned safety review
and verbally 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. The DSMB
will conduct additional periodic reviews and will also perform a
futility assessment once 125 adjudicated major adverse cardiac events
(MACE) have been observed. Resverlogix, the clinical steering
committee, and all investigators remain blinded to the actual safety
and efficacy results.

"The verbal recommendation of the DSMB to continue as planned in the
BETonMACE trial is consistent with the well-established safety
profile of apabetalone that has now been demonstrated in over 1,000
patients to date," stated Dr. Michael Sweeney, M.D., Senior Vice
President of Clinical Development. "We are encouraged by the
recommendation of the DSMB in the BETonMACE study and look forward to
reporting additional updates."

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 diseases such as high-risk cardiovascular disease (CVD),
diabetes mellitus (DM), chronic kidney disease, Alzheimer's disease,
Orphan diseases, and peripheral artery disease, while maintaining a
well described safety profile. Apabetalone is the only selective BET
bromodomain inhibitor in human clinical trials, currently in a Phase
3 trial BETonMACE in high-risk CVD patients with type 2 DM and low
high-density lipoprotein (HDL).

Resverlogix common shares trade on the Toronto Stock Exchange
(TSX:RVX).

For further information please visit http://www.resverlogix.com.

Follow us on Twitter: @Resverlogix_RVX
(https://twitter.com/resverlogix_rvx)
(https://twitter.com/resverlogix_rvx), or on our blog at
http://www.resverlogix.com/blog

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 Company's Phase 3
clinical trial and the potential role of apabetalone in the treatment
of CVD, DM, chronic kidney disease, Alzheimer's disease, Orphan
diseases, and peripheral artery disease. 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 http://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.

ORIGINAL APA-OTS TEXT - THE INFORMATION CONTAINED IN THIS PRESS RELEASE IS SUBJECT TO THE EXCLUSIVE RESPONSIBILITY OF THE ISSUER | PRN

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