Business
Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE Trial
Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in ...
About this update from Resverlogix Corp.
[{"type":"text","content":"\n\n\n\nResverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE 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, July 25, 2017\n\n\n\n\"BETonMACE Phase 3 Trial with apabetalone to expand to include the United States\" \n\n\n\nCALGARY, July 25, 2017 /CNW/ - Resverlogix Corp. (\"Resverlogix\" or the \"Company\") (TSX:RVX) is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA). In light of updated information regarding apabetalone, including: human exposure, clinical dosing and established acceptable safety margins, the FDA is allowing the Company to include United States of America (USA) patients in Phase 3 studies, including the BETonMACE trial. Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Brochure and the Informed Consent Documents. The primary objective of the BETonMACE study is to evaluate if treatment with apabetalone in addition to standard of care (SoC) as compared to placebo increases time to the first occurrence of a major adverse cardiac event (MACE) in high-risk cardiovascular disease patients with type 2 diabetes mellitus. \n\nMr. Donald McCaffrey, President and CEO stated, \"This is a major advancement for Resverlogix, having Phase 3 trial approval from both the European Authorities and FDA for apabetalone, which adds significant value to our program. FDA approval to proceed with the Phase 3 BETonMACE trial in the USA is well timed and should not have a major impact on the total duration of the BETonMACE trial.\" Mr. McCaffrey further commented, \"This progress is very encouraging and further validates our recently released data that confirmed apabetalone's ability to differentially affect genes and proteins between advanced chronic kidney disease (CKD) patients and normal subjects.\"\n\nDr. Mike Sweeney, Senior Vice President of Clinical Deve...