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Pivotal Therapeutics Inc PVTTF

Pivotal Therapeutics Inc is a Canada based pharmaceutical company. It focuses on Omega-3 therapies for cardiovascular disease and overall health. The products of the company are VASCAZEN which is a prescription-only medical food for the treatment of an Omega-3 Deficiency in patients with cardiovascular disease, OMAZEN, and BENEFISHIAL which provides pure Omega-3 fatty acids for the maintenance of health. The firm operates in the United States and Canada of which majority of the revenue is derived from the United States.


GREY:PVTTF - Post by User

Post by smithgeeon Jun 04, 2015 2:39pm
513 Views
Post# 23797765

Pivotal enrolls first patient in Pomega phase IIa trial

Pivotal enrolls first patient in Pomega phase IIa trial
Pivotal enrolls first patient in Pomega phase IIa trial
 
 
2015-06-04 14:31 ET - News Release
 
 
Dr. George Jackowski reports
 
FIRST PATIENT ENROLLED IN PIVOTAL'S POMEGA PHASE IIA CLINICAL TRIAL WITH PVT-100
 
Pivotal Therapeutics Inc. has enrolled 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 microTBC 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."
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