Resverlogix Randomizes First Patient in Taiwan/China Portion of the Phase 3 BETonMACE Clinical Trial
Calgary, Alberta (ots/PRNewswire) - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) today announced that the first patient has been randomized in Taiwan in the Phase 3 BETonMACE clinical trial with lead drug apabetalone intended for high-risk patients with cardiovascular disease ("CVD") and type 2 diabetes mellitus ("DM").
On July 8, 2015, Resverlogix and Shenzhen Hepalink Pharmaceutical Co., Ltd. ("Hepalink") closed a license agreement for China, Hong Kong, Taiwan, and Macau (the "Territories"). Under the terms of the agreement, Hepalink is responsible for certain clinical and development costs in the Territories, for a Taiwan/China patient population that is now being included in Resverlogix's Phase 3 BETonMACE trial. As a result of the randomization, Hepalink is now responsible for the first CAD$1 million payment to Resverlogix.
The license agreement also stipulates that when apabetalone reaches certain annual sales milestones in the Territories, ranging from 500 million renminbi ("RMB") to RMB 10 billion, Resverlogix will be eligible to receive sales-based milestone payments from Hepalink, each ranging from USD$5 million to USD$90 million. In addition, Hepalink will pay Resverlogix a royalty based on net sales. Total sales based milestones and royalty payments have an estimated potential in excess of USD$400 million. The license will expire on a region-by-region basis on the later of the 15th anniversary of the first commercial sale in such region or the expiry date of the last-to-expire of any licensed patent.
Dr. Michael Sweeney, M.D., Senior Vice President of Clinical Development stated, "With the assistance of our partner in China, Hepalink, we are pleased to announce the randomization of our first patient in BETonMACE in Taiwan. Total enrollment in the BETonMACE trial is now over 1,600 patients. With the addition of new active clinics in the Territories, and soon in the Netherlands and in Russia, we remain on track for full enrollment in the study by the fall of 2017."
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).
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 total sales based milestones and royalty payments in the Territories from Hepalink, the attainment of certain annual sales milestones of apabetalone in the Territories 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, and 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.