Pivotal Therapeutics Announces Notification of Patent Allowance for U.S. Application 13/584,480 Related to Combination Product of VASCAZEN® and Statin Therapy

WOODBRIDGE, ON, Oct. 7, 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 and overall health, announced that the United Stated Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Pivotal's U.S. Patent Application Serial Number 13/584,480 titled "STATIN and Omega-3 Fatty Acids for Reduction of Apolipoprotein-B Levels." This application includes claims intended to protect VASCAZEN^® and its formulation in conjunction with a Statin. This notice constitutes allowance of the patent and impending issuance. The issued patent would have a term that expires no earlier than in 2032.

Receipt of the Notice of Allowance in this application is further recognition of the novel properties of VASCAZEN^® formulation for the treatment of risk factors for cardiovascular disease, reduction of overall serum cholesterol levels, reduction in high blood pressure, increase in the HDL:LDL ratio, reduction of triglycerides and reduction of Apolipoprotein-B Levels, particularly when utilized in combination with a statin.

"In our REVEAL Study, which was recently published in Molecular and Cellular Biochemistry (MCB), http://link.springer.com/article/10.1007/s11010-014-2132-1/fulltext.html, we reported on the efficacy of the VASCAZEN^® formulation on the correction of the Omega-3 nutritional deficiency (OM3D) and its positive effects on cardiovascular disease risk factors in a double-blind randomized controlled cardiovascular patient population receiving VASCAZEN^® or placebo (corn oil).  In this study we observed that a sub group of patients that were on statins and VASCAZEN^® derived an added benefit beyond normalizing their lipid profile.  We are very excited that the USPTO has allowed claims that will protect our formulation in conjunction with a statin. We believe this combination could significantly benefit cardiovascular patients going forward," said Dr. George Jackowski, Co-Founder and Chief Scientific Officer of Pivotal.

This application is part of an expanding patent portfolio for Pivotal protecting its unique formulation with two (2) patent applications now either issued or allowed with the USPTO and over eight (8) additional applications pending in the United States.  Pivotal is also pursuing patent applications related to VASCAZEN^®'s formulation in multiple jurisdictions outside the United States.

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.

For more information about VASCAZEN^® please visit www.vascazen.com.

About Pivotal Therapeutics Inc.

Pivotal Therapeutics is a 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. For more information about Pivotal visit www.pivotaltherapeutics.us.

Disclosure Notice

The information contained in this document is as of October 7, 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.

Company Contacts: Kristine DiMatteo, Communications and Public Relations Manager, Phone: [phone] ext. 231, E-Mail: [email protected]; Investor & Media Contact: Stephen Kilmer, President, Kilmer Lucas Inc., Phone: [phone], E-Mail: [email protected]