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
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
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.
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.
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.