Pivotal Therapeutics Inc.

Pivotal Therapeutics Inc.

July 13, 2011 10:56 ET

Pivotal Therapeutics Inc. Enrolls Patients Into Clinical Marketing Trials for Its Lead Therapeutic, VASCAZEN™

TORONTO, ONTARIO--(Marketwire - July 13, 2011) - Pivotal Therapeutics Inc. (CNSX:PVO) announced today the commencement of its Clinical Marketing Trials to assess the effectiveness of its lead therapeutic VASCAZEN™.

VASCAZEN™ is a differentiated, proprietary prescription-grade Omega-3 product, formulated with a unique Eicosapentaenoic (EPA) to Docosahexaenoic (DHA) ratio of ultra-high purity, for utility as an aid in the dietary management of Omega-3 deficient cardiovascular disease patients through elevating EPA and DHA Omega-3 fatty acids.

Planned to conclude in August 2011 in the United States, the trial is a third-party researched, randomized, double blind study. Upon enrollment, patients' blood Omega-3 fatty acid levels are quantified using the "Omega Test" developed by Nutrasource Diagnostics Inc. (NDI), who is also conducting the trials.

Clinical Data will determine the competence of VASCAZEN™ as an aid in the dietary management of Omega-3 levels in subjects presenting to the clinical trial centre with deficient blood Omega-3 fatty acid levels through the quantification of the change in the sum of the subject's total blood fatty acid levels, as well as analysis of other changes in blood levels.

"Implementing the Omega Test in these trials will highlight Pivotal's novel approach and strategy in treating cardiovascular disease as a deficiency through the development of a combined, prescription-only, therapeutic and diagnostic tool kit for physicians," says Dr. George Jackowski, Chief Scientific Officer & Chair of Pivotal Therapeutics. "It is our goal to increase access and treatment options for cardiovascular patients and we are awaiting the Clinical Trial results and look forward to publishing the outcomes."

VASCAZEN™ will be launched both in Canada this October at the Canadian Cardiovascular Congress' Vancouver 2011 Conference and in the US this November at the American Heart Association's Scientific Sessions 2011 in Orlando, Florida.

About Pivotal Therapeutics Inc.

With offices in Toronto, Canada and Boca Raton, Florida, Pivotal Therapeutics is a publicly traded (CNSX:PVO) specialty pharmaceutical company with a focus on the treatment of cardiovascular disease. Pivotal Therapeutics' lead product VASCAZEN is a prescription medical food formulated to meet the dietary Omega-3 deficient needs of patients with cardiovascular disease through elevating Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) to levels associated with reduced risk of cardiovascular complications.

VASCAZEN is a >90% pure, proprietary EPA:DHA fatty acid formulation, protected by a series of both issued and pending US and foreign patents and commercialized by prescription only. This unique formulation will provide the cornerstone upon which a family of cutting edge combination products, with efficacy across a broad spectrum of cardiac care, will be commercialized.

About Nutrasource Diagnositics Inc.

Nutrasource Diagnostics Inc. (NDI) is located in the world-renowned University of Guelph Research Park. A hub for nutritional research activity, Nutrasource services the Natural Health Products Industry, the Food and Beverage Industry, Academia, Health Care Practitioners and Consumers. NDI has established itself as the world-wide leader in assisting the Natural Health Product and related industries in commercializing the health benefits of nutrition through scientific, evidence-based research and innovation with a focus on the betterment of humanity via ethical, considerate and credible scientific and business practices.

This press release contains forward-looking statements. Such forward-looking statements are subject to a number of risks, assumptions and uncertainties that could cause the Company's actual results to differ materially from those projected in such forward-looking statements. In particular, factors that could cause actual results to differ materially from those in forward looking statements include, our inability to obtain additional financing on acceptable terms, risk that our products and services will not gain widespread market acceptance; continued consumer adoption of digital technology, inability to compete with others who provide comparable products, the failure of our technology, inability to respond to consumer and technological demands, inability to replace significant customers; seasonal nature of our business and other risks detailed in our filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date made and are not guarantees of future performance. We undertake no obligation to publicly update or revise any forward-looking statements. When used in this document, the words "believe," "expect," "anticipate," "estimate," "project," "plan," "should," "intend," "may," "will," "would," "potential," and similar expressions may be used to identify forward-looking statements.

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