The Phase II trial is a double-blind, placebo-controlled trial evaluating 80 high risk geriatric patients following open heart surgery procedures. Patients receive either DCA i.v. or a placebo, initially administered as a bolus infusion immediately after surgery and then as a continuous infusion for 24 hours. This trial is meant to support the design of the Phase III METR(x)ICS (METabolic Treatment In Cardiac Surgery) trial by identifying the relevant clinical parameters, such as the reduction in time a patient spends in the intensive care unit following an open heart surgery procedure.
The primary endpoint of the trial is to demonstrate a trend in reducing the recovery time spent in the intensive care unit following surgery by the treatment group compared to placebo. CardioMetabolics has already received a special protocol assessment from the FDA for a Phase III trial of DCA i.v. Therefore, while the Phase II trial is not a regulatory requirement, it will provide key information for finalizing the design of the Phase III protocol.
Kimmo Lucas, president and CEO of CardioMetabolics, said: “We expect to complete the Phase II trial in the third quarter of 2008 and be able to review the results at that time in preparation for the Phase III METR(x)ICS trial.”