Pivotal Announces Publication of a Clinical Trial Showing Beneficial Effects of VASCAZEN® In The Correction of Omega-3 Deficiency In Cardiovascular Patients

Woodbridge, Ontario (ots/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(R) in the correction of Omega-3 deficiency in patients with
one or more risk factors associated with CVD and evaluated
VASCAZEN(R)'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(R)-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(R)-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(R) 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(R) 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(R) 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(R) 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(R) 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(R)'s unique and proprietary Omega-3 formulation and we
believe that the publication of this trial represents further
peer-reviewed validation of VASCAZEN(R) 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(R) 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(R)

VASCAZEN(R) 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(R) 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(R) 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(R)'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

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