Pivotal Therapeutics Announces Notification of Patent Allowance for U.S. Application 13/584,480 Related to Combination Product of VASCAZEN® and Statin Therapy

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 and overall health,
announced that the United Stated Patent and Trademark Office (USPTO)
has published notification of a Notice of Allowance for Pivotal's
U.S. Patent Application Serial Number 13/584,480 titled "STATIN and
Omega-3 Fatty Acids for Reduction of Apolipoprotein-B Levels." This
application includes claims intended to protect VASCAZEN(R) and its
formulation in conjunction with a Statin. This notice constitutes
allowance of the patent and impending issuance. The issued patent
would have a term that expires no earlier than in 2032.

Receipt of the Notice of Allowance in this application is further
recognition of the novel properties of VASCAZEN(R) formulation for
the treatment of risk factors for cardiovascular disease, reduction
of overall serum cholesterol levels, reduction in high blood
pressure, increase in the HDL:LDL ratio, reduction of triglycerides
and reduction of Apolipoprotein-B Levels, particularly when utilized
in combination with a statin.

"In our REVEAL Study, which was recently published in Molecular
and Cellular Biochemistry (MCB), http://link.springer.com/article/10.
1007/s11010-014-2132-1/fulltext.html, we reported on the efficacy of
the VASCAZEN(R) formulation on the correction of the Omega-3
nutritional deficiency (OM3D) and its positive effects on
cardiovascular disease risk factors in a double-blind randomized
controlled cardiovascular patient population receiving VASCAZEN(R) or
placebo (corn oil). In this study we observed that a sub group of
patients that were on statins and VASCAZEN(R) derived an added
benefit beyond normalizing their lipid profile. We are very excited
that the USPTO has allowed claims that will protect our formulation
in conjunction with a statin. We believe this combination could
significantly benefit cardiovascular patients going forward," said
Dr. George Jackowski, Co-Founder and Chief Scientific Officer of
Pivotal.

This application is part of an expanding patent portfolio for
Pivotal protecting its unique formulation with two (2) patent
applications now either issued or allowed with the USPTO and over
eight (8) additional applications pending in the United States.
Pivotal is also pursuing patent applications related to VASCAZEN(R)'s
formulation in multiple jurisdictions outside the United States.

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.

For more information about VASCAZEN(R) please visit
http://www.vascazen.com.

About Pivotal Therapeutics Inc.

Pivotal Therapeutics is a 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.
OMAZEN(R) is a pharmaceutical grade Omega-3 providing over 90% pure
Omega-3 in each capsule for the maintenance of good health. OMAZEN(R)
is a patented product available for sale and distribution in Canada.
For more information about Pivotal visit
http://www.pivotaltherapeutics.us.

Disclosure Notice

The information contained in this document is as of October 7,
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; Investor & Media Contact: Stephen
Kilmer, President, Kilmer Lucas Inc., Phone: +1-647-872-4849, E-Mail:
stephen@kilmerlucas.com

ots Originaltext: Pivotal Therapeutics Inc
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