A data review by the independent Data Safety Monitoring Board resulted in a recommendation for the BETonMACE trial to continue as planned without any modification.
CALGARY, March 17, 2017 /CNW/ - 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 disease (CVD) patients has completed a third planned safety review and 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 trial data.
"Consistent with the two previous DSMB reviews, this third review and recommendation of the DSMB to continue as planned in BETonMACE permits the trial to remain on schedule. We have now enrolled more than 1,200 patients in BETonMACE and apabetalone remains well-tolerated with a consistent safety profile," stated Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development.
Filing of Quarterly Financial Statements and Management's Discussion & Analysis
The Company has filed its unaudited interim Consolidated Financial Statements and related Management's Discussion & Analysis for the quarter ended January 31, 2017, with Canadian securities regulatory authorities. Copies of these documents may be obtained online at www.sedar.com, or the Company's website, www.resverlogix.com, or by emailing ir@resverlogix.com.
Upcoming Conference Participation
Resverlogix is planning to participate in the following industry conferences in the months of March and April.
| • | ACC.17, American College of Cardiology - 66th Annual Scientific Session & Expo | |
| Location: | Washington, DC | |
| Date: | March 17th – 19th, 2017 | |
| Presentation Info: | 11:00 – 11:10 (EDT), March 17th, Vascular Medicine Moderated Poster Theater, Poster Hall, Hall C | |
| Poster: | "Apabetalone (RVX-208) Lowers Cardiovascular Disease (CVD) in Diabetes Mellitus by a Mechanism Involving Microbiome Mediated Activity on the Complement Pathway" | |
| • | ||
| Location: | Barcelona, Spain | |
| Date: | March 20th – 22nd, 2017 | |
| Presentation Time: | 9:30 (CET), March 21st | |
| Presenting: | Mr. Donald J. McCaffrey, President & Chief Executive Officer | |
| • | AD/PD 2017, 13th International Conference on Alzheimer's & Parkinson's Disease | |
| Location: | Vienna, Austria | |
| Date: | March 29th – April 2nd, 2017 | |
| Presentation Info: | 8:00 - 18:00 (CET), March 29th | |
| Presenting: | Dr. Ewelina Kulikowski, Senior Vice President, Research & Development | |
| Poster: | "Apabetalone, a BET Bromodomain Inhibitor, Suppresses Inflammatory Mediators in Microglia that Contribute to Neurodegenerative Disease" | |
Resverlogix posters and presentations noted above will be made available on the company website prior to their respective presentation time.
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, dialysis, 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).
Follow us on Twitter: @Resverlogix_RVX (https://twitter.com/resverlogix_rvx), or on our blog at http://www.resverlogix.com/blog
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 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 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.
SOURCE Resverlogix Corp.