WOODBRIDGE, ON, Jan. 27, 2015 /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 and overall health,
announced today that it has received the final and unrestricted
authorization 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 stabilization 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
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.
"This is a significant milestone for Pivotal as our patented
formulation moves towards a drug indication in Phase IIa in
Europe," said 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."
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. BeneFishial™ is the
first product in Pivotal's new nutraceutical product line, which
has been specifically designed to be sold in the OTC direct to
retail or direct to consumer markets.
Disclosure Notice
The information contained in this document is as January 27, 2015. 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.