Pivotal Therapeutics Inc.

Pivotal Therapeutics Inc.

September 12, 2011 10:24 ET

Pivotal Therapeutics Inc. Expands REVEAL Trial to Florida

WOODBRIDGE, ONTARIO--(Marketwire - Sept. 12, 2011) - Pivotal Therapeutics Inc. (CNSX:PVO), a specialty pharmaceutical company with a focus on the treatment of cardiovascular disease, today announced the expansion of its REVEAL Trial, "A randomized, Placebo-Controlled Study of VASCAZEN™ in Patients With Deficient Blood Omega-3 Fatty Acid levels", to a Florida-based study centre. The study was initiated this past June.

"Expanding to a Clinical Study site in Florida is a strategic decision based upon Pivotal's growing presence in the region and the overwhelmingly positive response from our network of cardiologists in the area anticipating the launch of VASCAZEN™" said Rachelle MacSweeney, President of Pivotal Therapeutics.

The REVEAL Trial is a 200 patient, randomized, placebo-controlled, double-blind parallel study of Omega-3 deficient cardiovascular patients with elevated triglycerides. The study will assess the effectiveness of Pivotal's lead therapeutic VASCAZEN™ by elevating Eicosapentaenoic (EPA) and Docosahexaenoic (DHA) Omega-3 fatty acids.

"Findings from an earlier Open Label Study of VASCAZEN™ conducted by Pivotal indicate that over 80% of Study candidates' initial blood results showed Omega-3 deficiency, using its companion OmegaScore™ Diagnostic Test." said Dr. George Jackowski, Chairman, and Chief Scientific Officer. "I am extremely excited to share the full study results as part of Pivotal's presentation at the Rodman & Renshaw conference on September 13th in New York City."

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.

Disclosure Notice

The information contained in this document is as of September 12, 2011. 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.

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