Resverlogix' Phase 2 ASSERT trial dosing complete ahead of schedule

Completion occurs 5 months ahead of schedule

Resverlogix is pleased to announce that the Phase 2 ASSERT clinical trial for its lead drug, RVX-208, a small molecule therapy for the treatment of atherosclerosis has now completed dosing. "The completion of dosing for our Phase 2 ASSERT trial, five months ahead of schedule and without any alterations to the dose levels of the three drug receiving cohorts, is another major step forward in the development of this important cardiovascular drug. Our clinical team and our collaborators at the Cleveland Clinic will now spend the next few months assessing the study results to best plan for upcoming trials. The swift completion of the ASSERT study further allows us to make better assessments in identifying optimal dosing regimens moving forward," explained Donald J. McCaffrey, President and CEO of Resverlogix. McCaffrey continued, "Earlier studies have indicated that the drug worked best in those subjects with low HDL, therefore we will further assess if RVX-208 has a targeted effect in this high risk cardiovascular disease population. The rapid enrollment and dosing success for this trial was in large part due to having one organized Internal Review Board (IRB) for all 40 sites involved in the trial."

The ASSERT trial is a randomized, double-blind, placebo-controlled, multi-centered US study for 13 weeks of administration of RVX-208, which has enrolled 299 patients with stable coronary artery disease for a period of 13 weeks. The primary endpoint of the study is to determine if RVX-208 will produce an increase in plasma Apolipoprotein A-I (ApoA-I) levels compared to placebo group after three months of dosing. Other objectives are to examine the safety and tolerability of RVX-208 and to compare the dose and time response relationship for ApoA-I as well as to examine key reverse cholesterol markers involved with HDL functionality.

In related clinical news the parallel Phase 2 ASSURE trial for RVX-208, which announced its first site activation on February 25th, will be reassessing its enrollment procedure. Since the ASSERT trial provides us with data much faster than first anticipated, we can also now apply pertinent findings to the ASSURE trial. In order to expedite enrollment, while continuing our primary patient safety concerns, the ASSURE trial is being voluntarily halted on a temporary basis in order to modify enrollment procedures. "While the ASSERT trial set records for enrollment, the much more intricate ASSURE trial will not for the reason that the inclusion criteria is much more detailed and intensive. ASSURE currently requires a patient must have had a heart attack within the past four weeks. The patient is then required to voluntarily submit to having two invasive Intravascular Ultrasound (IVUS) both at the start and finish of the 90 day drug treatment period. We believe that we can enhance the enrollment procedure by modifying the inclusion criteria. One such option would be to include any patients sent to the Catheter Lab, thus greatly increasing the pool of patients that we would be able to draw from for enrolment in this trial. Patients will also now benefit from any added knowledge that we are about to gain from the successful completion of dosing in the ASSERT trial," stated Donald McCaffrey.

In other news today, Donald J. McCaffrey will be providing an updated corporate and clinical overview at 1:00 pm EDT. A slide presentation will be followed by a question and answer session regarding the impact of the early completion of the ASSERT trial and the enhancement of enrollment procedures for the ASSURE trial.