Pivotal Therapeutics (OTCQX:PVTTF) (CNSX:PVO), a pharma company focused on Omega-3 therapies for cardiovascular disease (CVD), says that it has met the main goals of a trial for its prescription-only medical food, Vascazen.
As well as meeting the primary endpoint of correcting an Omega-3 deficiency in a trial called "Reveal", the Woodbridge, Ontario-based company said in a statement Tuesday that Vascazen also achieved "statistical significance" in various secondary endpoints in patients presenting with elevated triglycerides - a type of fat found in the blood.
The company also said 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, from May 1 to 3.
"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 Pivotal in the release, citing chairman and chief scientific officer, Dr. George Jackowski.
"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."
The Vascazen trial, a randomized, double blind, placebo controlled, study that enrolled 110 patients, was designed to test effects of the therapy in the correction of Omega-3 deficiency in patients with one or more risk factors associated with cardiovascular disease. The study also looked at the effects of Vascazen on cardiovascular risk factors such as triglycerides, and different types of cholesterol.
"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," said Dr. Jackowski.
The company's lead product, Vascazen, is a prescription-only medical food, specifically made for the dietary management of an Omega-3 deficiency in cardiovascular patients. It is the second to market prescription-only Omega-3 therapy available in the U.S., and is available by prescription nationwide.
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