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Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial
Resverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Ph...
About this update from Resverlogix Corp.
[{"type":"text","content":"\n\n\n\nResverlogix Reports Positive FDA Type B Meeting on Design Issues Relating to a Proposed Phase 2a Kidney Dialysis Trial\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n\n\n\n\n\n\n\nCanada NewsWire\nCALGARY, Feb. 23, 2017\n\n\n\nProtocol comments and recommendations incorporated\n\n\n\nCALGARY, Feb. 23, 2017 /CNW/ - Resverlogix Corp. (\"Resverlogix\" or the \"Company\") (TSX: RVX) today announced the receipt of the final minutes of an in-person Type B meeting with the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA). The purpose of the meeting was to request written comments, recommendations and feedback on Resverlogix's proposed protocol for its Phase 2a kidney dialysis trial.  The primary objective of the study will be to evaluate if treatment with apabetalone in combination with standard of care (SoC) decreases alkaline phosphatase in comparison to placebo and SoC. \n\nIn light of guidance received from the FDA, the Phase 2a study design will be separated in two parts.  Part A will involve a single-dose pharmacokinetic (PK) study in eight patients receiving hemodialysis. The PK results from Part A will influence the dose selection for Part B. Part B will be a double-blind, randomized, placebo-controlled, sequential cross-over study with apabetalone, and is designed to evaluate biomarker changes and safety parameters with apabetalone in up to 30 patients with end-stage renal disease treated with hemodialysis. Resverlogix intends to file an official Investigative New Drug (IND) application and proceed with the planned Phase 2a clinical trial in 2017. \n\nAbout Advanced CKD & Dialysis \n\nAdvanced Chronic Kidney Disease (CKD) encompasses CKD stages 4 & 5, and it can be alternatively defined as an estimated glomerular filtration rate (eGFR) of <30 ml/min/1.73m2. Reported in the 2016 United States Renal Data System (USRDS) Annual Report, approximately 1.4 million patients in the US have advanced CKD, 474,000 of which are on dialysis treatment. According to the USRDS, advanced CKD...