Sep 10 2010
Increased number of patients and the focus is on patients with greatest medical need
Resverlogix Corp. ("Resverlogix" or the "Company") (TSX:RVX) announces that the Company's Phase 2 clinical trial, called ASSURE (ApoA-1 Synthesis Stimulation in Acute Coronary Syndrome patients), has made important modifications to the design of the trial which have the potential to demonstrate a more powerful endpoint for the planning of future clinical trials for RVX-208.
Key changes to this clinical trial include: - Raising the number of patients to be recruited from 120 to over 230. - All patients will now undergo an intravascular ultrasound (IVUS) assessment versus the previously planned 60 patients. - Trial sites increase from 20 to approximately 45. - Clinical trials will be conducted in multiple countries to accelerate recruitment. - The study will include patients with low HDL. - Primary endpoint is now plaque regression.
Donald J. McCaffrey, President & CEO of Resverlogix noted, "The most important take away message is that by moving the end point to atherosclerosis regression this will provide a more robust proof of concept. Achieving plaque regression could potentially reduce the development time for RVX-208 by two years."
The planned trial is currently a three month study and dosing is expected to start in 2010. Any changes to the trial will be updated on www.clinicaltrials.gov.