CALGARY, Alberta, Feb. 08, 2018 (GLOBE NEWSWIRE) -- Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) highlighted today recent key accomplishments and 2018 targets.
The Company has recently achieved several major accomplishments:
1) The Company received the U.S. Food and Drug Administration (“FDA”) acceptance of its Phase 3 BETonMACE clinical trial protocol;
2) The U.S. will be the 15th country participating in BETonMACE;
3) In excess of 95% of the approximately 2,400 patients outlined in the Phase 3 BETonMACE clinical trial’s protocol have been enrolled;
4) The Company also received the acceptance of the FDA of its application to commence a Phase 2a Kidney Dialysis trial;
5) The Company raised in excess of $100 million of additional capital and repaid its loan in full;
6) The Company has no outstanding debt.
In early 2018, the Company entered into a licencing agreement with Medison Pharma Ltd. for the Company’s lead therapeutic candidate, apabetalone (RVX-208), in Israel and the Palestine Authority.
For 2018, the Company targets commencing enrollment of US-based patients in its Phase 3 BETonMACE trial in the first half of 2018, conducting a Sample Size Reestimation Analysis by approximately mid-2018, completing enrollment in BETonMACE by the second quarter of 2018 based on the currently targeted 2,400 patients, and having top-line data around the end of 2018. Furthermore, the Company targets randomizing its first patient in its Phase 2a Kidney Dialysis clinical trial and enrolling its first patient in its Fabry Disease clinical trial during the second quarter of 2018.
The Company intends to raise additional capital during and following the first quarter of 2018 to fund operations and strengthen its financial position. The Company also intends to pursue additional licensing opportunities, some of which are expected to contain up front payments.
Donald J. McCaffrey, President and Chief Executive Officer, stated, “We are very pleased with the considerable progress and achievements we’ve made during the last year and are working diligently on achieving our targets for the current year. With top-line data expected to be available around year-end, this remains a very exciting and pivotal time for Resverlogix and its shareholders.”
Remedial Delisting Review
As previously reported, as a result of the Company’s reliance upon the financial hardship exemption in connection with the Company’s previously-announced $87 million private placement with Shenzhen Hepalink Pharmaceutical Co. Ltd., the TSX commenced an automatic remedial de-listing review, which is normal practice when a listed issuer relies on this exemption. The Company anticipates further improving its financial position by raising additional capital. The Company has received a 60-day extension to April 12, 2018 for the TSX’s review of the Company’s compliance with all of the TSX listing requirements.
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 timing of significant milestones for the Phase 3 BETonMACE clinical trial, Phase 2a kidney dialysis clinical trial and Fabry Disease clinical trial, the Company’s intention to raise additional capital and pursue licensing opportunities, 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.