WOODBRIDGE, ON, Dec. 17, 2014 /PRNewswire/ - Pivotal
Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the
"Company"), a specialty pharmaceutical company with a focus on
Omega-3 therapies for cardiovascular disease (CVD) and overall
health, announced that on December 16,
2014 the French FDA in Paris (ANSM: Agence Nationale de la Sécurité
du Médicament - French National Agency for Drug Safety) officially
cleared the clinical evaluation part of the
VASCAZEN® POMEGA Phase IIa trial
protocol.
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
VASCAZEN® product or 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 is being coordinated and monitored
locally by Preventor µTBC GmbH, a German drug safety corporation
specialized in pre-clinical and clinical pharmacovigilance, that
provides guidance to Pivotal in Europe. More than 4,000 patients are diagnosed
with carotid plaque stenosis in France annually.
"Pivotal is privileged to have the opportunity to be working
with the French FDA and Preventor on the
VASCAZEN® POMEGA trial, said Dr.
George Jackowski, Pivotal's Founder
and Chief Scientific Officer. "With this trial, it opens up
VASCAZEN®'s formulation as a drug
indication in Europe and
potentially in the U.S. marketplace.
About VASCAZEN®
VASCAZEN® is currently available in the U.S.
as a prescription only medical food specifically formulated for the
dietary management of an Omega-3 deficiency in cardiovascular
patients. VASCAZEN® is a >90% pure Omega-3
with a proprietary 6:1 EPA:DHA fatty acid formulation, protected by
a series of both U.S. 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% 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.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX:PVTTF;
CSE:PVO), specialty pharmaceutical company with a focus on
cardiovascular disease and overall health. Pivotal Therapeutics'
lead product VASCAZEN® is a prescription only
medical food formulated to meet the dietary Omega-3 deficient needs
of patients with cardiovascular disease through elevating
Eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA) to
levels associated with reduced risk of cardiovascular
complications. OMAZEN® is a pharmaceutical grade
Omega-3 providing over 90% pure Omega-3 in each capsule for the
maintenance of good health. OMAZEN® is a patented
product available for sale and distribution in Canada.
Disclosure Notice
The information contained in this document is as of
December 17, 2014. This press release
contains forward-looking statements. Such forward-looking
statements are subject to a number of risks, assumptions and
uncertainties that could cause Pivotal's actual results to differ
materially from those projected in such forward-looking statements.
These statements can be identified by the use of words such as
"will", "anticipate", "estimate", "expect", "project", "forecast",
"intend", "plan", "believe", "project", "potential", and similar
expressions with any discussion of future operating or financial
performance or events. In particular, factors that could cause
actual results to differ materially from those in forward looking
statements include the following: Pivotal's inability to obtain
additional financing on acceptable terms; growth in costs and
expenses; inability to compete with others who provide comparable
products; risk that the Company's products will not gain widespread
market acceptance; risks relating to the Company's ability to
maintain its CSE listing. Forward-looking statements speak only as
of the date made and are not guarantees of future performance.
The Company undertakes no obligation to publicly update or
revise any forward-looking statements contained in this document as
a result of new information or future events or developments. The
CSE has not reviewed and does not accept responsibility for the
adequacy or accuracy of this information.
SOURCE Pivotal Therapeutics Inc.