Pivotal Therapeutics Inc. announced that it has received the final and unrestricted authorization from the Agence Nationale de la Securite du Medicament - French National Agency for Drug Safety to conduct a Phase IIa clinical trial with its PVT-100 drug candidate. PVT-100 uses VASCAZEN®'s proprietary formulation for the stabilization of vulnerable plaque in patients undergoing carotid endarterectomy, a surgical procedure to remove material accumulated in the arteries to reduce the risk of stroke. The VASCAZEN® POMEGA Phase IIa clinical trial is a double-blinded placebo controlled study in over 100 patients scheduled to undergo vascular invasive surgery for carotid endarterectomy at the University Hospital of Strasbourg, France.

Patients shall be randomized to receive either Pivotal's uniquely formulated drug candidate PVT-100 or a placebo, for six consecutive weeks. The composite primary endpoint of the trial consists of histomorphological, biochemical and immunological status of the vascular plaque.