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Wednesday, 1 May 2013
Pivotal Therapeutics to present "top line" results from Vascazan clinical study at American Heart Association conference
Pivotal Therapeutics (OTCQX:PVTTF) (CNSX:PVO), a pharmaceutical company focused on Omega-3 therapies for cardiovascular disease, says it will be presenting its "top line" results from a recent clinical trial at the American Heart Association's Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions.
The event will be held in Lake Buena Vista, Florida, from May 1-3.
The poster entitled, “Treatment of Omega-3 Nutritional Deficiency Improves Cardiovascular Disease Risk Factors: Results of the Randomized, Double-Blind, Placebo-Controlled VASCAZEN® -REVEAL Trial”, will be presented on Friday May 3 from 8:00am to 10:00am.
In April, the company said it met the primary endpoint in its "Reveal" trial, which was to correct an Omega-3 deficiency in patients with one or more risk factors associated with cardiovascular disease. The data, says the company, represents a significant milestone as a treatment option for “thousands of people who are Omega-3 deficient and suffer from elevated triglycerides yet remain below the threshold of ‘very high’ triglycerides required for treatment with currently available prescription medications.”
The randomized, double-blind, placebo-controlled study enrolled 110 patients, and also saw Vascazen achieve “statistical significance” in various secondary endpoints, including positive effects on lipid profiles.
The company's product, Vascazen, is an FDA-regulated medical food product developed to lower cardiovascular health risks in Omega-3 deficient cardiac patients, including high triglycerides, or fatty substances in the blood that are associated with coronary disease.
The 90 percent-pure product, which was introduced in the U.S. in November 2011, provides those suffering from heart disease with levels of the most important Omega-3 fatty acids in fish oil – EPA and DHA – that the company says are ideal, and cannot be achieved just through simple changes in diet alone.
Omega 3s are widely known to result in improved blood flow, reduced inflammation, and positive effects on lipid metabolism.
Eicosapentaenoic acid (EPA), which has strong anti-inflammatory properties, and docosahexaenoic acid (DHA) are found in cold water fish such as salmon, mackerel, halibut, sardines, tuna, and herring, but without enough fish, supplements are needed to fill the body’s needs.
On Monday, the company announced that for the 12 months that ended December 31, 2012, it reported a loss of $3.6 million, or 5 cents per share, compared with a slightly bigger loss of $3.8 million, or 6 cents per share, in 2011. It told investors that the decrease in loss resulted from an increase in sales, netted against a reduction in operating expenses.
Vascazen, which avoided the lengthy FDA pre-approval process that is required with drugs, is available with a prescription in all major pharmacies throughout the U.S. Currently, the company's sales reps are focused on the eastern seaboard in the U.S., which contains the highest prevalence of cardiovascular disease-related illness in the nation.
With plans to close a financing for some $5 million in proceeds, the company says it can build out its dedicated sales force to more than 35 people. Its sales reps are compensated “heavily on commission”, which Pivotal says drives sales and higher volumes.
Pivotal will be exhibiting in Booth #3 at the ATVB 2013 Scientific Sessions and will be available to respond to questions or provide additional information on the poster or its product.