WOODBRIDGE, ON, Oct. 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 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 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.
SOURCE Pivotal Therapeutics Inc.