WOODBRIDGE, ON, Sept. 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.
SOURCE Pivotal Therapeutics Inc.