Pivotal Therapeutics, a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease and overall health, announced that it has received the final and unrestricted authorisation from the Agence Nationale de la Sécurité du Médicament - 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 stabilisation 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 randomised 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.
"This is a significant milestone for Pivotal as our patented formulation moves towards a drug indication in Phase IIa in Europe," says Dr. George Jackowski, Pivotal's founder and chief scientific officer. "We look forward to enrolling our first patient in the second quarter of this year."
VASCAZEN is currently available in the US as a prescription-only medical food specifically formulated for the dietary management of an Omega-3 deficiency in cardiovascular patients. VASCAZEN is a >90 per cent pure Omega-3 with a proprietary 6:1 EPA:DHA fatty acid formulation, protected by a series of both US and foreign patents.
VASCAZEN has been clinically shown to correct an Omega-3 deficiency within eight weeks of treatment with positive concomitant effects on the lipid profiles, mainly a 48 per cent reduction of triglycerides and an increase of HDL without negative impact on the LDL-C lipid profile. VASCAZEN's results were achieved with a dose of 3 grams of EPA and DHA per day of a prescription grade, high purity, uniquely formulated Omega-3.