WOODBRIDGE, Ontario,
October 7, 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 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® 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®
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® 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® or placebo (corn oil). In this
study we observed that a sub group of patients that were on statins
and VASCAZEN® 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®'s formulation 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.
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.
For more information about VASCAZEN® 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® 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. 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