Pivotal Therapeutics enrolls first patient in POMEGA Phase IIa clinical trial of PVT-100

Jun 4 2015

Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CSE: PVO), a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, announced today the enrollment of the first patient in Pivotal's POMEGA Phase IIa clinical trial with PVT-100.

The 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.

The trial entitled "Impact of an optimized Omega 3 formulation on the biochemical and histopathological composition of atheromatous plaques in patients to undergo carotid endarectomy" is sponsored by the University Hospital of Strasbourg and authorized by the French national supervisory authority ANSM, the equivalent to the U.S. FDA. This trial is coordinated by an interdisciplinary team of six vascular surgeons and twenty health professionals and monitored by the French health authorities via the national Clinical Trial Management System (CTMS). This system supervises all therapeutic clinical trials performed in France. Product packaging, supply and trial logistics including on site quality control/compliance monitoring is performed by German drug safety corporation Preventor µTBC GmbH.

"We are very excited about the enrollment of the first patient in the POMEGA trial," stated Dr. George Jackowski, Co-Founder and Chief Scientific Officer. "Positive results of the trial will allow for new indications for prescription Omega-3 formulations, initiating novel therapeutic regimes beyond treating patients with very high triglycerides."