Woodbridge, Ontario (ots/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 ("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(R) in the correction of Omega-3 deficiency in patients with one or more risk factors associated with CVD and evaluated VASCAZEN(R)'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(R)-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(R)-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(R) 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(R) 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(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.
Treatment with VASCAZEN(R) 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(R) 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(R)'s unique and proprietary Omega-3 formulation and we believe that the publication of this trial represents further peer-reviewed validation of VASCAZEN(R) 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(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.
VASCAZEN(R) 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(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) 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(R)'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.
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