WOODBRIDGE, Ontario,
October 8, 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 13/584,403 titled "Cholesterol Absorption
Inhibitor and Omega-3 Fatty Acids for the Reduction of Cholesterol
and for the Prevention or Reduction of Cardiovascular,
Cardiac and Vascular Events." This application includes claims
intended to protect VASCAZEN® and its
formulation in conjunction with at least one azetidinone
cholesterol absorption inhibitor. 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®'s 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, and reduction of
triglycerides, particularly when utilized in combination with at
least one azetidinone cholesterol absorption inhibitor.
"We are very excited that the USPTO has allowed claims that will
protect our formulation in conjunction with a cholesterol
absorption inhibitor. We believe that the recently allowed patents
combining the key cholesterol lowering agents (Statins) and
cholesterol absorption inhibitors with our unique Omega-3 fatty
acid formulation could significantly benefit the management of
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 three (3) patent
applications now either issued or allowed with the USPTO and over
seven (7) 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 in the VASCAZEN®-REVEAL Trial
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. The
publication of the trial entitled "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"
can be found in Molecular and Cellular
Biochemistry (MCB), http://link.springer.com/article/10.1007/s11010-014-2132-1/fulltext.html.
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 8, 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