Pivotal Therapeutics VASCAZEN®-REVEAL Trial Meets Primary and Secondary Endpoints - VASCAZEN® Shows 121% Correction of an Omega-3 Deficiency (p< 0.0001) with a Concomittant 48% Reduction in Triglyceri

Woodbridge, Ontario (ots/PRNewswire) -

Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty
pharmaceutical company with a focus on Omega-3 therapies for
cardiovascular disease (CVD) and overall health, presented positive,
statistically significant, top-line results from its
VASCAZEN(R)-REVEAL trial for the Company's lead product VASCAZEN(R),
a unique >90% pure Omega-3 prescription medical food with a
proprietary 6:1 EPA:DHA fatty acid formulation. The results were
presented on May 3, 2013 at the American Heart Association's
Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013
Scientific Sessions.

The purpose of the VASCAZEN(R)-REVEAL trial was to demonstrate
that CVD patients are nutritionally deficient in Omega-3 fatty acids,
and through treatment with VASCAZEN(R) such deficiency can be
corrected, resulting in the improvement of patient lipid profiles and
ultimately reducing CVD risk factors. The trial was a double blind,
placebo-controlled study comprised of 110 subjects randomized and
stratified by baseline triglyceride levels. The trial analyzed both
the placebo (n=54) and VASCAZEN(R) treated (n=56) groups at baseline
and after eight weeks of treatment. The primary endpoints were the
change in the Omega-Score and Omega-Index, with secondary endpoints
including the change in serum triglyceride, lipoprotein cholesterol
(VLDL, LDL, HDL, ApoB, and subfractions), and hsCRP. The Omega-Score
and Omega-Index are proprietary diagnostic tests that measure
circulating blood levels of Omega-3 in individuals. The Omega-Score
and Omega-Index are independent measures of risk factors for CVD. The
levels correlate with the risk of CVD events; patients with low
levels of Omega-3 have a higher incidence of CVD events than patients
with high levels of Omega-3.

VASCAZEN(R) was demonstrated to be highly effective in correcting
an Omega-3 deficiency. In eight weeks of treatment a statistically
significant (p<0.0001) increase of 121% in the Omega-Score and 112%
(p<0.0001) in Omega-Index (the blood levels of EPA, DHA and DPA) was
observed in VASCAZEN(R) treated subjects. The VASCAZEN(R)-REVEAL
trial confirms Pivotal's Open Label Study results conducted in 2011
that identified >80% of CVD patients as Omega-3 deficient. The
VASCAZEN(R)formulation had a profound effect on correcting an Omega-3
deficiency and positive effect on lipid profiles, mainly the
reduction of triglycerides and raising HDL in as little as eight
weeks of treatment.

Triglyceride Reduction Levels and Secondary Endpoints Exceeded
Company Expectations

The median placebo adjusted reduction in triglycerides in the
VASCAZEN(R) treatment group was 48%. This reduction was statistically
significant (p<0.0005). The median baseline triglyceride levels were
264.00 mg/dL and 274.50 mg/dL for the patient groups treated with
placebo and VASCAZEN(R), respectively. The VASCAZEN(R) treated group
showed VLDL-C reduction of 30% (p=0.0023) and HDL-C increase of 9%
(p=0.0069) without significantly affecting LDL-C, ApoB or hsCRP
levels. The safety profile of VASCAZEN(R) was similar to placebo with
no treatment related serious adverse events reported in the trial.

"We are very pleased with the results of the VASCAZEN(R)-REVEAL
trial," said Dr. George Jackowski, Chairman and Chief Scientific
Officer. "Both primary and secondary endpoints were met, with the
evidence supporting the efficacy of VASCAZEN(R) in correcting an
Omega-3 deficiency and addressing some important CVD risk factors,
such as patient lipid profiles. The statistically significant
elevation in Omega-3 levels, drop in triglycerides, and the elevation
of HDL cholesterol, all in eight weeks, evidences the deficiency is
being corrected and patients are seeing results. The positive data
from the VASCAZEN(R)-REVEAL study show that VASCAZEN(R) could be an
important therapeutic option for correcting an Omega-3 deficiency,
thereby reducing CVD risk factors including high triglycerides in
patients who do not meet the current criteria for pharmaceutical
treatment targeting high triglycerides."

The VASCAZEN(R)-REVEAL trial is the only trial that addresses an
Omega-3 deficiency in cardiovascular patients. "We are happy to see
that the trial's screening results confirm the deficiency levels we
saw in our earlier open label study," says Rachelle MacSweeney,
President and COO. "The evidence shows that the Omega-3 deficiency
presents in a significant number of CVD patients, representing a
large market opportunity for VASCAZEN(R) and we look forward to
incorporating the data from the study into our current marketing
message."

The VASCAZEN(R)-REVEAL trial confirms that Omega-3 deficiency is
prevalent in individuals with CVD, and that such a deficiency can be
corrected with VASCAZEN(R), a 6:1 EPA:DHA Omega-3, resulting in a
concomitant and significant placebo-corrected reduction in
triglycerides and VLDL, and increase in HDL-C in patients with high
triglycerides (200-500mg/dL), without adversely affecting LDL-C.

About the Study

The VASCAZEN(R)-REVEAL trial was a randomized, double blind,
placebo controlled, multi-center USA based study that enrolled 110
patients. The purpose of the study was to evaluate the effects of
VASCAZEN(R) in the correction of Omega-3 deficiency in patients with
one or more risk factors associated with CVD, and to evaluate
VASCAZEN(R)'s concomitant effects on cardiovascular risk factors
including triglycerides, VLDL cholesterol, LDL cholesterol, and HDL
cholesterol among others. The primary efficacy endpoint was the
correction of an Omega-3 deficiency, and secondary endpoints included
positive effects on lipid profiles, without any adverse events.

Of the 110 patients enrolled > 85% were Omega-3 deficient. The
VASCAZEN(R)-REVEAL trial is the first to determine dietary levels of
Omega-3 in plasma and in red blood cells using the Omega-Score and
Omega-Index diagnostics. Improvement after treatment with VASCAZEN(R)
and the concomitant beneficial effects on CVD risk factors in
patients with high triglycerides (200-500mg/dL) was analyzed.

About VASCAZEN

VASCAZEN(R) is a currently available 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)is
the second to market prescription only Omega-3 therapy available in
the U.S. and is available by prescription nationwide.

About Pivotal Therapeutics Inc.

Pivotal Therapeutics is a publicly traded (OTCQX: PVTTF) (CNSX:
PVO) 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[TM] is a prescription grade
Omega-3 providing >90% total Omega-3 in each capsule with a unique
6:1 ratio of EPA:DHA. OMAZEN[TM] is a patented product available for
sale and distribution in Canada.

Disclosure Notice

The information contained in this document is as of May 7, 2013.
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 CSNX 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. CNSX has not
reviewed and does not accept responsibility for the adequacy or
accuracy of this information.

SOURCE: Pivotal Therapeutics Inc.

For further information:

Company Contacts:

Rachelle MacSweeney
President and Chief Operating Officer
Phone: +1-905-856-9797
E-Mail: rmacsweeney@pivotaltherapeutics.us

Kristine DiMatteo
Communications and Public Relations Manager
Phone: +1-905-856-9797 ext. 231
E-Mail: kdimatteo@pivotaltherapeutics.us

http://www.pivotaltherapeutics.us

ots Originaltext: Pivotal Therapeutics Inc
Im Internet recherchierbar: http://www.presseportal.de