WOODBRIDGE, ON, Sept. 10, 2014 /CNW/ - 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 ("CVD") and
overall health, announced today the publication of results of a
prospective randomized controlled trial in the U.S. that evaluated the
effects of VASCAZEN® in the correction of Omega-3 deficiency in patients with one or more
risk factors associated with CVD and evaluated VASCAZEN®'s concomitant effects on these risk factors including triglycerides,
VLDL cholesterol, LDL cholesterol, and HDL cholesterol.
The publication titled, "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," was authored by Nisar Shaikh, Jason Yantha, Sabah
Shaikh, William Rowe, Maggie Laidlaw, Carla Cockerline, Abbas Ali,
Bruce Holub and George Jackowski, and is now available in the
peer-reviewed journal titled Molecular and Cellular Biochemistry (MCB) with open public access at http://link.springer.com/article/10.1007/s11010-014-2132-1/fulltext.html.
Of the 655 patients screened 89% were Omega-3 deficient. The VASCAZEN®-REVEAL trial was the first to determine levels of Omega-3 in plasma and
in red blood cells using the Omega-Score and Omega-Index diagnostics.
Omega-Score measures blood levels of EPA, DHA and DPA and Omega-Index
measures EPA and DHA in red blood cells. VASCAZEN® was demonstrated to be highly effective in correcting an Omega-3
deficiency in CVD patients with normal and high triglycerides. In eight
weeks of treatment with 4 capsules/day of VASCAZEN® there was a 121% improvement in the Omega-Score and 112% improvement in
Omega-Index in CVD patients with hypertriglyceridemia (200-500 mg/dL).
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.
Treatment with VASCAZEN® was associated with a 48% reduction in triglycerides, a 30% reduction
in VLDL-C and a 9% increase in HDL-C without adversely affecting LDL-C
in patients with hypertriglyceridemia. The safety profile of VASCAZEN® was similar to placebo with no treatment related serious adverse events
reported in the trial.
Dr. George Jackowski, Chief Scientific Officer and co-author of the MCB paper said, "Clinical evidence continues to highlight VASCAZEN®'s unique and proprietary Omega-3 formulation and we believe that the
publication of this trial represents further peer-reviewed validation
of VASCAZEN® as an effective medical food for correcting an Omega-3 deficiency."
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX:PVTTF; CSE: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.
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 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. 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.
The information contained in this document is as of September 10, 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.
For further information:
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