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FDA Grants Resverlogix Approval to Commence a Phase 1 Clinical Trial for RVX-208
New class of ApoA-I/HDL drugs to reverse atherosclerosis enters the clinic TSX Exchange Symbol: RVX
About this update from Resverlogix Corp.
[{"type":"text","content":"\n\n\n\nNew class of ApoA-I/HDL drugs to reverse atherosclerosis enters the\n\n\nclinic\n\n\nTSX Exchange Symbol: RVX\n\n\nCALGARY, Dec. 10 /CNW/ - Resverlogix Corp. ("Resverlogix") (TSX:RVX)\nannounced today that it has received approval by the US Food and Drug\nAdministration (FDA) to initiate a Phase 1a clinical trial of oral RVX-208 in\nthe USA. RVX-208 is a novel first-in-class small molecule that increases the\nproduction of ApoA-I and HDL. ApoA-I is regarded as the critical\ncardioprotective protein for the treatment of cardiovascular diseases.\n\n\nThe Phase I clinical trial is taking place at a leading US contract\nresearch organization. The trial consist of three arms, an ascending single\ndose, a fed and fasted dose effect study, and a 7-day ascending multiple dose\nthat will enroll a total of 70-80 healthy volunteers. The primary objective of\nthe trial is to evaluate oral RVX-208 in healthy adult subjects for safety,\ntolerability, and pharmacokinetics. Results from this Phase 1a trial will be\nused for optimizing dosing for future trials including our Phase 1b trial.\n\n\nGregory S. Wagner, PhD, Senior Vice President, Preclinical Development of\nResverlogix, stated that, "RVX-208 possesses a very favorable pharmacological\nand pharmaceutical profile. This compound is an excellent choice to be the\nfirst drug candidate from our preclinical pipeline, our research and\ndevelopment team has worked aggressively to rapidly advance it into clinical\ndevelopment."\n\n\n"This field has been developing for 50 years. In multiple human and\nanimal studies over-expression or repeated infusion of ApoA-I inhibit\nprogression and induce regression of atherosclerosis in both animals and\nhumans," stated Dr. Jan Johansson, MD, PhD. Senior Vice President of Clinical\nAffairs of Resverlogix. "We have identified a way to increase the endogenous\nproduction of ApoA-I via a small molecule drug. The initiation of this\nclinical trial is a milestone for the field of ApoA-I research," confirmed Dr.\nJohansson.\n\n\n"Clearance of our investigational new drug application from the US Food\nand Drug Administration was a major accomplishment for our company; however,\nbeginning the clinical assessment is, to date, Resverlogix's most important\nmilestone," said Mr. Donald McCaffrey, President and ...