Scientific Data Supports Superiority of Pivotal's Unique Omega-3 Formulation

WOODBRIDGE, ON, Aug. 19, 2014 /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 that an article entitled, "Redox-sensitive induction of Src/PI3-kinase/Akt and MAPKs pathways activate eNOS in response to EPA:DHA 6:1," authored by Faraj Zgheel, Mahmoud Alhosin, Sherzad Rashid, Mélanie Burban, Cyril Auger and Valérie B. Schini-Kerth has been published in the current issue of the scientific journal PLOS ONE and is available at http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0105102.

The findings of Zgheel et al. demonstrate that the sustained endothelial vasodilatory effect of Omega-3 formulations are EPA:DHA ratio and purity dependent and involve predominantly the endothelial nitric oxide synthase derived nitric oxide formation.

The Pivotal 6:1 EPA:DHA formulation of VASCAZEN® was shown to cause the most pronounced sustained vasodilatory effect when compared to a 1:1 EPA:DHA, pure EPA or pure DHA.  The study published by the researchers of the University of Strasbourg, France, is the first to demonstrate that the biological activity of Omega-3 formulations is not linked to either the ratio or the purity alone but depends on the interplay of the components of each respective formulation.

"The significance of these results emphasizes not only the superior sustained endothelial vasodilatory profile of Pivotal's VASCAZEN®, but also points to its beneficial effects in Omega-3 deficient individuals," said Dr. George Jackowski, Chief Scientific Officer. "We are very excited that the VASCAZEN® formulation was superior to the other existing commercial products in the marketplace in terms of sustained coronary vasodilation (i.e. increase of blood flow) which is important for patients with Coronary Heart Disease who have compromised coronary vessels."

About PLOS ONE

PLOS ONE publishes primary research from all areas of science and employs a combination of peer review and post-publication rating and commenting, to maximize the impact of every report it publishes. We are published by the Public Library of Science (PLOS), the open-access publisher whose goal is to make the world's scientific and medical literature a public resource. All works published in PLOS ONE are Open Access.

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. OMAZEN® is a pharmaceutical grade Omega-3 providing over 90% pure Omega-3 in each capsule for the maintenance of good health. OMAZEN® is a patented product available for sale and distribution in Canada.

About VASCAZEN®

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.

Disclosure Notice

The information contained in this document is as of August 19, 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.



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