Parallel Phase 2 studies could expedite development timeline
TSX Exchange Symbol: RVX
CALGARY, Oct. 16 /PRNewswire-FirstCall/ - Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) provided an outline yesterday at the Company's Annual General Meeting for shareholders highlighting the Company's clinical plan path for Resverlogix's lead drug, RVX-208, for the treatment of cardiovascular disease.
Resverlogix outlined that the next two clinical studies will be performed in parallel. Start up activities for both studies have already commenced in conjunction with the Cleveland Clinic and the IVUS Steering Committee. The studies, following normal FDA submission guidelines, will include a Phase 2 Pilot Intravascular Ultrasound (IVUS) trial to examine early lipid effects, and atheroma plaque characterization of the coronary vessel wall in 60 acute coronary syndrome patients. In parallel to this, a Phase 2 Dose-Ranging trial will be conducted in 280 stable cardiovascular patients on standard of care therapy, including statins, examining lipid changes. Both of these clinical trials will dose patients with coronary disease who are on standard treatment for 13 weeks. The start-up activities for these trials have commenced with screening, randomization and first dosing expected in Q1 2010. Updates on future clinical trials will be announced as they progress.
"We have made a significant advancement in our clinical trial plans due to the successful results in our most recent Phase 1b/2a clinical trial," said Donald J. McCaffrey, President and CEO of Resverlogix. "We have now been able to initiate Phase 2 Pilot IVUS study activities. For the first time we will now be able to assess RVX-208 effects on actual atherosclerosis plaque within the arterial wall of the heart vessels. We are performing this study in the acute coronary syndrome population which is one of the prioritized patients groups. This is a significant miles
|SOURCE Resverlogix Corp.|
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