WOODBRIDGE, ON, April 1, 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 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 13/584,428 entitled
"Omega 3 Fatty Acid for use as a Prescription Medical Food and
Omega 3 Fatty Acid Diagnostic Assay for the Dietary Management of
Cardiovascular patients with Cardiovascular Disease (CVD) who are
Deficient in Blood EPA and DHA Levels." This notice
constitutes allowance of the patent and impending issuance. The
issued patent would have a term that expires no earlier than in
2032.
The present invention provides a kit for the dietary management
of cardiovascular patients with cardiovascular disease who are
deficient in blood Eicosapentaenoic acid (EPA) and Docosahexaenoic
acid (DHA) levels. This kit includes a diagnostic assay for
determining blood levels of EPA, DHA and Docosapentaenoic acid
(DPA) and a pharmaceutical grade prescription medical food Omega-3
fatty acid formulation containing about 90% or more Omega-3 fatty
acids by weight including a combination of EPA, DPA and DHA in a
weight ratio of EPA:DHA of 5.7:1 to 6.3:1. The sum of the EPA, DHA
and DPA are about 82% by weight of the total formulation and about
92% of the total Omega-3 fatty acid content of the composition. EPA
+ DHA are about 80% of the total formulation and about 89% of the
total Omega-3 fatty acid content of the composition.
"This is a key patent in our portfolio that surrounds our unique
Omega-3 formulation," said Dr. George
Jackowski, Pivotal's Founder and Chief Scientific Officer.
"In fact, in this allowed patent, we were able to obtain separate
independent claims to our unique Omega-3 formulation that is the
basis of a series of products being commercialized by Pivotal."
This application is part of Pivotal's expanding patent portfolio
that protects its unique formulation. The Company has a total of
four (4) issued and allowed patents and seven (7) patent
applications currently in prosecution in the U.S. The Company is
pursuing patent applications related to
VASCAZEN®'s formulation, composition,
combinations with existing obesity and cardiovascular drugs and an
Omega-3 fatty acid diagnostic assay in the U.S. and in multiple
jurisdictions outside the United
States.
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.
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 April 1, 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.
