Pivotal Therapeutics VASCAZEN® - Meets Primary Endpoint in Reveal Trial - Top Line Results Accepted for Presentation at the American Heart Association's ATVB 2013 Scientific Sessions
WOODBRIDGE, ON, April 9, 2013 /CNW/ - Pivotal Therapeutics Inc. (OTCQX: PVTTF) (CNSX: PVO), a specialty pharmaceutical company with a focus on Omega-3 therapies for cardiovascular disease (CVD) and overall health, is pleased to announce that VASCAZEN® met its primary endpoint in the REVEAL trial. Additionally, VASCAZEN® achieved statistical significance in various secondary endpoints in patients presenting with elevated triglycerides (>200mg/dL < 500mg/dL). The data has been accepted for presentation at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions (ATVB) at Lake Buena Vista, Florida, USA, May 1-3, 2013.
"This data represents a significant milestone for VASCAZEN® as a treatment option for the thousands of people who are Omega-3 defeicient and suffer from elevated triglycerides yet remain below the threshold of "very high" triglycerides required for treatment with currently available prescription medications" said Dr. George Jackowski, Chairman and Chief Scientific Officer. "This landmark study is among the first that examined Omega-3 deficiency pre and post treatment and brings the importance of its correction to the forefront as an important part in managing CVD patients. We are very excited to be presenting our top line results at this premier conference as it attracts the top clinicians and scientists in all areas of cardiovascular disease focusing on lipids and heart disease."
Dr. Jackowski gratefully acknowledges the outstanding contribution of the Contract Research Organization (CRO), Nutrasource Diagnostics Inc., Guelph, Ontario, Canada, for its professional execution and management of the VASCAZEN®-REVEAL trial. "The CRO trial team has done a superb job in the overall management of this pivotal study," stated Dr. Jackowski.
About the Study
The VASCAZEN®-REVEAL trial is a randomized, double blind, placebo controlled, multi-center USA based study that enrolled 110 patients. The purpose of the study was to evaluate the effects of VASCAZEN® in the correction of Omega-3 deficiency in patients with one or more risk factors associated with CVD, and to evaluate VASCAZEN®'s concomitant effects on cardiovascular risk factors including triglycerides, VLDL cholesterol, LDL cholesterol, and HDL cholesterol among others. The primary efficacy endpoint was the correction of an Omega-3 deficiency, and secondary endpoints included positive effects on lipid profiles, without any adverse events.
VASCAZEN® is 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® is the second to market prescription only Omega-3 therapy available in the U.S. and is available by prescription nationwide.
About Pivotal Therapeutics Inc.
Pivotal Therapeutics is a publicly traded (OTCQX: PVTTF) (CNSX: 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.
The information contained in this document is as of April 9, 2013. 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. CNSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this information.
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