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Resverlogix Receives Approval From The FDA Cardiovascular and Renal Division To Proceed With A Requested Apabetalone Clinical Trial
Resverlogix Receives Approval From The FDA Cardiovascular and Renal Division To Proceed Wi...
About this update from Resverlogix Corp.
[{"type":"text","content":"\n\n\n\nResverlogix Receives Approval From The FDA Cardiovascular and Renal Division To Proceed With A Requested Apabetalone Clinical 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, May 15, 2017\n\n\n\nApabetalone expands to a second major clinical indication in kidney dialysis patients\n\n\n\nCALGARY, May 15, 2017 /CNW/ - Resverlogix Corp. (\"Resverlogix\" or the \"Company\") (TSX:RVX) is pleased to announce the acceptance, by the Cardiovascular and Renal Products Division of the U.S. Food and Drug Administration (FDA), of  the Company's Investigational New Drug (IND) application to commence a Phase 2a kidney dialysis trial. The primary objective of the study will be to evaluate if treatment with apabetalone in addition to standard of care (SoC) decreases alkaline phosphatase in comparison to placebo and SoC.\n\n\"We are thrilled to have received approval to investigate a second major indication along with FDA regulatory advancement for apabetalone at the same time. This is a very exciting prospect for Resverlogix's overall advancement.  This progress is very encouraging and further validates our previously released data that confirmed apabetalone's ability to differentially affect genes and proteins between advanced chronic kidney disease (CKD) patients and normal subjects,\" stated Donald McCaffrey, President and CEO.\n\n\"Apabetalone and BET inhibition represent a truly novel approach to potentially impacting the extreme high risk of cardiovascular disease (CVD) events in this important patient population,\" stated Dr. Kamyar Kalantar-Zadeh, Chairman of Resverlogix's Renal Clinical Advisory Board.  \"We are excited to test apabetalone and the new science of epigenetics and BET inhibition on advanced CKD patients. These patients are in great need of novel approaches to reduce CVD risk\", Dr. Kalantar-Zadeh further commented.\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...