Resverlogix Presents ASSERT Human Clinical Trial Data at the American Heart Association Late Breaker Session
News Nov 18, 2010
Resverlogix Corp. announces its top line results of the ASSERT Phase 2 clinical trial which will be highlighted at the prestigious American Heart Association Scientific Sessions 2010 Late Breaking Clinical Trial session, by principal investigator Dr. Stephen Nicholls of the Cleveland Clinic.
The top line ASSERT trial data was designed to answer questions about how to best proceed with future trial designs for Resverlogix' lead oral small molecule drug RVX-208.
The ASSERT trial data demonstrated that the three key biomarkers in the reverse cholesterol transport (RCT) process showed dose dependant and consistent improvement. The trial showed dose dependent increases in ApoA-l, statistically significant increases in HDL cholesterol including alpha1 particles or functional HDL, and statistically significant increases in large HDL particles. RCT is a pathway by which accumulated cholesterol is transported from the arterial wall to the liver for excretion, thus reducing and/or preventing atherosclerosis.
In the high dose, ApoA-I achieved a 5.6% increase with a statistical value of p=0.06. The overall ApoA-I biomarker showed a dose trending statistical significance of p=0.035.
Data presented also showed that the ApoA-I and other HDL particles continued to be increasing at the end of the 12 week study. Both the 8.3% HDL cholesterol increase and the 21.1% large particle HDL increase were highly statistically significant.
"These are very encouraging early findings which suggest the drug (RVX-208) is working in the established patient population that it was designed for, being patients with advanced coronary disease," said Dr. Stephen Nicholls, MBBS, PhD, Medical Director of Intravascular Ultrasound and Angiography Core Laboratories at Cleveland Clinic and Clinical Director of the Cleveland Clinic Center for Cardiovascular Diagnostics and Prevention.
Donald McCaffrey, President and Chief Executive Officer of Resverlogix commented, "The study largely replicates findings previously seen in our earlier 28 day trial, more importantly these findings are now being shown in patients with coronary artery disease on optimal standard of care. The positive changes seen in this trial represent advancement over the current best standard of care available in the USA. We are now well positioned to advance RVX-208 to the next clinical trial having witnessed the substantial and consistent elevation of HDL by ApoA-I production; which strongly indicates that RVX-208 should remove unwanted plaque from the arterial wall which is our main goal."
Resverlogix Senior Vice President of Medical Affairs Dr. Jan Johansson stated, "In patients who received the newer class of statins and had baseline HDL below 45mg/dL, an important high-risk subpopulation, the middle dose of 200 mg saw the most pronounced increases of 12% in ApoA-I.
An additional presentation at the AHA meeting was given by Dr. Norman Wong, Chief Scientific Officer of Resverlogix, containing new data detailing the effects of RVX-208 in vivo. The presentation was titled "RVX-208: An Orally Administrated Small Molecule Reduces Atherosclerosis in ApoE Null Mouse and Raises ApoA-I/HDL in Humans".
In the ApoE null mice model of atherosclerosis, the oral administration of RVX-208 reduced aortic plaques in two separate models. The presented model showed plaque reductions of up to 41%.