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Further Analysis of the ASSURE Data Finds a Responder Group for RVX-208 with Statistically Significant Regression of Coronary Atherosclerosis
"In patients with low HDL receiving RVX-208 and Rosuvastatin (Crestor ® ), plaque reg...
About this update from Resverlogix Corp.
[{"type":"text","content":"\n\n\n\"In patients with low HDL receiving RVX-208 and Rosuvastatin (Crestor®), plaque regression was twice as pronounced as compared to the\n pre-specified primary endpoint.\" \n\n\nTSX Exchange Symbol: RVX\n\n\nCALGARY, Sept. 3, 2013 /CNW/ - Resverlogix Corp. (TSX:RVX) today\n announced the Full Analysis Set (FAS) data from 281 treated patients in\n its Phase 2b ASSURE clinical trial evaluating RVX-208 using\n intravascular ultrasound (IVUS) in high-risk cardiovascular patients.\n Current findings show that the below median HDL (<39 mg/dL) baseline\n population consisted of 92 patients who were taking either Rosuvastatin\n (Crestor®) or Atorvastatin (Lipitor®) together with RVX-208. Those patients taking Rosuvastatin and RVX-208\n had a highly statistically significant Percent Atheroma Volume (PAV)\n plaque regression of -1.43% with probability value of p<0.002. This PAV\n regression exceeded the trial's pre-specified PAV endpoint (-0.6%) by\n more than two-fold. But those patients taking Atorvastatin (Lipitor®) together with RVX-208 had a PAV plaque progression of +0.19% with a\n non-significant probability value. The synergistic effect of the\n Rosuvastatin and RVX-208 combination is the basis for two recent\n provisional patent applications by Resverlogix.\n\n\nOngoing analysis is providing important insights into why the ASSURE\n topline results, reported previously on June 27, 2013, did not meet its\n primary endpoint of PAV change of -0.6%. Third party analysis of the\n ASSURE data showed that Rosuvastatin enhanced the actions of RVX-208\n leading to synergistic treatment effects on PAV.\n\n\nThe responder population (i.e. HDL <39 mg/dL taking Rosuvastatin and\n RVX-208) exceeded the primary endpoint and also surpassed secondary\n endpoints reflecting regression in coronary atherosclerosis. These\n measures included total atheroma volume (TAV) and changes in the 10 mm\n most diseased segment of the coronary arteries, we noted marked\n regression versus baseline of -12.3 mm3 ( p< 0.0001) and -4.3 mm3  (p<0.0001), respectively. Other secondary endpoints assessed in this\n population were biomarkers of reverse cholesterol transport (RCT),\n including: HDLc, ApoA-I and large HDL particles which increased by\n 18.2% (p<0.0001), 16.4% (p<0.0001) and 74.7% (p<0.0001), respectivel...