WOODBRIDGE, Ontario,
September 10, 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 today the publication of
results of a prospective randomized controlled trial in the U.S.
that evaluated the effects of VASCAZEN® in
the correction of Omega-3 deficiency in patients with one or more
risk factors associated with CVD and evaluated
VASCAZEN®'s concomitant effects on these
risk factors including triglycerides, VLDL cholesterol, LDL
cholesterol, and HDL cholesterol.
The publication titled, "Efficacy of a unique omega-3
formulation on the correction of nutritional deficiency and its
effects on cardiovascular disease risk factors in a randomized
controlled VASCAZEN®-REVEAL Trial," was
authored by Nisar Shaikh,
Jason Yantha, Sabah Shaikh,
William Rowe, Maggie Laidlaw, Carla
Cockerline, Abbas Ali, Bruce
Holub and George Jackowski,
and is now available in the peer-reviewed journal titled
Molecular and Cellular Biochemistry (MCB) with open public
access at
http://link.springer.com/article/10.1007/s11010-014-2132-1/fulltext.html.
Of the 655 patients screened 89% were Omega-3 deficient. The
VASCAZEN®-REVEAL trial was the first to
determine levels of Omega-3 in plasma and in red blood cells using
the Omega-Score and Omega-Index diagnostics. Omega-Score measures
blood levels of EPA, DHA and DPA and Omega-Index measures EPA and
DHA in red blood cells. VASCAZEN® was
demonstrated to be highly effective in correcting an Omega-3
deficiency in CVD patients with normal and high triglycerides. In
eight weeks of treatment with 4 capsules/day of
VASCAZEN® there was a 121% improvement in
the Omega-Score and 112% improvement in Omega-Index in CVD patients
with hypertriglyceridemia (200-500 mg/dL). The
VASCAZEN® formulation had a profound
effect on correcting an Omega-3 deficiency and positive effect on
lipid profiles, mainly the reduction of triglycerides and raising
HDL in as little as eight weeks of treatment.
Treatment with VASCAZEN® was associated
with a 48% reduction in triglycerides, a 30% reduction in VLDL-C
and a 9% increase in HDL-C without adversely affecting LDL-C in
patients with hypertriglyceridemia. The safety profile of
VASCAZEN® was similar to placebo with no
treatment related serious adverse events reported in the trial.
Dr. George Jackowski, Chief
Scientific Officer and co-author of the MCB paper said,
"Clinical evidence continues to highlight
VASCAZEN®'s unique and proprietary Omega-3
formulation and we believe that the publication of this trial
represents further peer-reviewed validation of
VASCAZEN® as an effective medical food for
correcting an Omega-3 deficiency."
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.
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.
Disclosure Notice
The information contained in this document is as of
September 10, 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.
For further information:
Company Contacts:
Kristine DiMatteo
Communications and Public Relations Manager
Phone: +1-905-856-9797 ext. 231
E-Mail: kdimatteo@pivotaltherapeutics.us
Investor & Media Contact:
Stephen Kilmer
President, Kilmer Lucas Inc.
Phone: +1-647-872-4849
E-Mail: stephen@kilmerlucas.com