- Published: 22 June 2015
- Written by Editor
Resverlogix Officially Attains Phase 3 Status with a European Regulatory Authority
CALGARY , June 22, 2015 - Resverlogix Corp. (RVX.TO) today announced that following recent meetings with various European regulatory bodies, the first confirmation for our Phase 3 clinical plan has officially been received. A further regulatory and protocol design update will be provided to the market post the approval of additional regulatory bodies and the launch of our planned Phase 3 clinical trial entitled BETonMACE.
"This represents a momentous step forward in the clinical development of RVX-208," stated Donald McCaffrey , president and chief executive officer of Resverlogix. "With this important regulatory confirmation now complete, we expect to launch the upcoming BETonMACE Phase 3 clinical trial this fall. The primary endpoint of the BETonMACE trial is designed to show a relative risk reduction (RRR) of Major Adverse Cardiac Events (MACE) in high-risk cardiovascular and diabetes mellitus (DM) patients, as we have seen in previous Phase 2 clinical trials with RVX-208," further stated Mr. McCaffrey.
RVX-208 is a first-in-class, small molecule selective BET bromodomain inhibitor. BET bromodomain inhibition is an epigenetic mechanism that can turn disease-causing genes off, returning them to a healthier state. RVX-208 is the first and only BET inhibitor selective for BRD4-BD2, producing a nexus of biological effects with potentially important benefits for patients with diseases such as cardiovascular disease (CVD), diabetes mellitus (DM), Alzheimer's disease, peripheral artery disease, and chronic kidney disease while maintaining an excellent safety profile. Resverlogix is planning to study RVX-208 in a proposed Phase 3 clinical trial in CVD patients with DM and low HDL.
Resverlogix Corp. is developing RVX-208, a first-in-class, small molecule selective BET bromodomain inhibitor for the potential treatment of patients with cardiovascular disease, diabetes mellitus, Alzheimer's disease, peripheral artery disease, and chronic kidney disease. RVX-208 is the only selective BET bromodomain inhibitor in clinical trials. Resverlogix's common shares trade on the Toronto Stock Exchange (RVX.TO). For further information please visit www.resverlogix.com. We can be followed on our blog at http://www.resverlogix.com/blog and via Twitter https://twitter.com/resverlogix_rvx @Resverlogix_RVX.
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 a Phase 3 clinical trial planned by the Company, research and development activities and the potential role of RVX-208 in the treatment of cardiovascular disease, diabetes mellitus, Alzheimer's disease, peripheral artery disease, and chronic kidney 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.
Donald J. McCaffrey
President and CEO
Director of Investor Relations & Corporate Communications