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 enh
|SOURCE Resverlogix Corp.|
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