WOODBRIDGE, Ontario,
December 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.
Company Contacts: Kristine
DiMatteo, Communications and Public Relations Manager,
Phone: +1-905-856-9797 ext. 231, E-Mail:
kdimatteo@pivotaltherapeutics.us