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
triglycerides (p<0.0005)
WOODBRIDGE, ON, May 7, 2013 /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®-REVEAL trial for the Company's lead
product VASCAZEN®, 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®-REVEAL trial
was to demonstrate that CVD patients are nutritionally
deficient
in Omega-3 fatty acids, and through treatment with
VASCAZEN® 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® 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® 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® treated subjects. The
VASCAZEN®-REVEAL trial confirms Pivotal's
Open Label Study results conducted in 2011 that
identified >80% of CVD patients as Omega-3 deficient. The
VASCAZEN® 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® 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®, respectively. The
VASCAZEN® 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®
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®-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® 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®-REVEAL study
show that VASCAZEN® 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®-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® and we look forward to incorporating
the data from the study into our
current marketing message."
The VASCAZEN®-REVEAL trial confirms that
Omega-3 deficiency is prevalent in individuals with
CVD, and that such a deficiency can be corrected with
VASCAZEN®, 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®-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® in the
correction of Omega-3 deficiency in patients with one or more
risk factors associated with CVD, and to evaluate
VASCAZEN®'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®-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® and
the concomitant beneficial effects on CVD risk factors in
patients
with high triglycerides (200-500mg/dL) was analyzed.
About VASCAZEN
VASCAZEN® is a currently available 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® 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® 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. OMAZENTM is a prescription grade
Omega-3 providing >90% total Omega-3 in each
capsule with a unique 6:1 ratio of EPA:DHA.
OMAZENTM 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.