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Successful CANTOS Inflammation Trial Supports Rationale for Resverlogix' Ongoing BETonMACE Trial
Calgary, Alberta (ots/PRNewswire) - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) is pleased to announce that key findings from the recently completed CANTOS trial, which demonstrate that targeting residual inflammatory risk resulted in a reduction in the incidence of Major Adverse Cardiovascular Events ("MACE"), validate the importance of reducing inflammation as a therapeutic strategy for treating Cardiovascular Disease ("CVD").
Novartis' Phase 3 CANTOS trial was designed to investigate the efficacy, safety and tolerability of ACZ885 (canakinumab) in combination with standard of care in people with a prior heart attack and heightened inflammation. Similar to Resverlogix' ongoing Phase 3 BETonMACE trial, the primary endpoint of the CANTOS study was time to first occurrence of a narrowly defined 3-point MACE, a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
As reported on the CardioBrief website (http://www.cardiobrief.org/), the CANTOS trial is "being hailed by experts for finally validating the role of inflammation in heart disease." CANTOS demonstrated the benefit of targeted therapy, an evolving paradigm in medicine. Similarly, treatment with Resverlogix' apabetalone has demonstrated a reduction in the inflammatory mediator IL-6 by 29 percent and positively modified the neutrophil/lymphocyte ratio, a well-known marker of inflammation in cardiovascular patients, analogous to the recent observations from CANTOS. This information is included in the Resverlogix posters being presented at the European Society of Cardioligists ("ESC") Congress 2017, as noted below, and available on the Company website HERE (http://www.resverlogix.com/media/presentations-publications.html#.V8Lq-pgrKhc). This data potentially explains the MACE reduction results observed in Resverlogix's Phase 2 trials.
Mr. Donald McCaffrey, President and CEO, stated, "The CANTOS trial is a major advancement in proving that inflammation and not just lipids underlie cardiovascular disease. This trial validates, for the first time, that anti-inflammatory therapies can address the residual risk in cardiovascular disease that exists despite intense lipid management. Our lead drug, apabetalone, has marked effects on reducing key inflammation markers such as CRP, IL6 and MCP1, and other biological pathways important for innate immunity, coagulation and calcification. In fact, Resverlogix's previous Phase 2 broad MACE results in trials with apabetalone compare favourably to the reported CANTOS results. For this reason, we remain optimistic about and look forward to completion of BETonMACE. Our Phase 3 trial will test for the first time, that by modulating the multiple pathways underlying CVD, including inflammation, by epigenetic modification, we can reduce MACE outcomes in high risk patients."
Professor Kausik Ray, Imperial College London, and Chairman of the BETonMACE Clinical Steering Committee, commented, "the BETonMACE Phase 3 trial is designed to test for a reduction in MACE in high risk CVD patients with diabetes who have residual inflammatory risk (and much higher absolute risk than patients in the CANTOS trial). Patients included in BETonMACE are those with a recent heart attack and diabetes, both of which result in a highly inflamed vasculature and the CANTOS results are encouraging for the potential success of the BETonMACE trial. Further, the BETonMACE population represent a huge unmet medical need with a predicted annual CVD event rate of over 7 percent which compares to about 4.3 percent in the CANTOS study."
Resverlogix Hosted Satellite Symposium at the ESC Congress 2017
The Company also announced today that on Saturday, August 26, 2017, it hosted a symposium titled: "Managing Diabetes & CVD: Is epigenetics a new way forward?" at the ESC Congress 2017.
The agenda and speakers were as follows:
Lina Badimon, MD - Barcelona, Spain
Managing high risk diabetes patients with cardiovascular disease: What works, and what else can we do? - Kausik Ray, MD - Imperial College London, United Kingdom
Promise of epigenetic modulation as a target in atherosclerotic patients
- Erik Stroes, MD - Academic Medical Centre, Amsterdam, Netherlands
Insights from the first trials in epigenetics in human: What is the way forward?
- Stephen Nicholls, MD - Adelaide, Australia
Presentations will be made available HERE (http://www.pace-cme.org/).
Resverlogix also presented two posters at the congress titled:
i) "Lowering the neutrophil to lymphocyte ratio by the BET inhibitor, apabetalone: potential implications for cardiovascular events in high risk patients" Poster Presentation Details: Date: Sunday, August 27, 2017 Time: 9:30am - 10:45am CET Session number: 302 Session title: Poster Session 2 ii) "Apabetalone (RVX-208) impacts key biomarkers and pathways associated with cardiovascular disease in patients with severe renal impairment" Poster Presentation Details: Date: Tuesday, August 29, 2017 Time: 3:30pm - 4:30pm CET Session number: 307 Session title: Poster Session 7
The posters are available HERE (http://www.resverlogix.com/media/presentations-publications.html#.V8Lq-pgrKhc) on the Company's website.
- BETonMACE has successfully completed a total of 4 safety reviews by the Data Safety Monitoring Board - BETonMACE has over 1,750 patients enrolled, representing approximately 75 percent of total planned enrollment.
In 2015, Resverlogix initiated a global Phase 3 clinical trial called BETonMACE with apabetalone for the reduction of MACE in high-risk CVD patients with type 2 diabetes mellitus and low high-density lipoprotein (HDL). The primary endpoint is to evaluate if treatment with apabetalone as compared to placebo increases time to the first occurrence of a MACE, defined as a single composite endpoint of: cardiovascular death, non-fatal myocardial infarction, or stroke. Secondary endpoints include: revascularization and unstable angina; changes in apolipoprotein A-I (apoA-I), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG); changes in Hemoglobin A1c (HbA1c), fasting glucose, and fasting insulin; and changes in alkaline phosphatase (ALP) and estimated glomerular filtration rate (eGFR) in Stage 3 CKD patients.
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 the potential role of apabetalone in the reduction of MACE outcomes in high risk patients and 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 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.