Pivotal Therapeutics (OTCQX:PVTTF) (CNSX:PVO), a specialty pharmaceutical company focused on Omega-3 therapies for cardiovascular disease (CVD), revealed today results from its Vascazen "Reveal" clinical trial, saying the product was "highly effective" in correcting an Omega-3 deficiency.
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.
The main aim of the Reveal trial, which the company says has been met, was to show that cardiovascular disease patients are nutritionally deficient in Omega-3 fatty acids, and through treatment with Vascazen, such deficiency can be corrected - resulting in improved patient lipid profiles, and ultimately reducing risk factors of heart disease.
Lipid profiles are an entire panel of blood tests that serve as an initial broad medical screening tool for abnormalities in lipids, such as cholesterol and triglycerides.
After eight weeks of treatment, the company said Tuesday a "statistically significant" increase of 121 per cent in the Omega-Score and 112 per cent in the Omega-Index - both diagnostic tests that measure circulating blood levels of Omega-3 in individuals - was seen in the Vascazen-treated subjects.
The double blind, placebo-controlled study, which was made up of 110 subjects, analyzed both the placebo and Vascazen-treated groups at baseline and after eight weeks of treatment.
Pivotal told investors today that the trial also revealed that secondary goals, such as triglyceride reduction, exceeded company expectations.
It said the median placebo adjusted reduction in triglycerides in the Vascazen treatment group was 48 per cent, a "statistically significant" figure. Levels of HDL, known as the "good cholesterol", actually increased by 9 per cent, without negatively impacting levels of LDL - or the "bad cholesterol".
The safety profile of the product was found to be similar to placebo, with no treatment-related serious adverse events reported.
“We are very pleased with the results of the VASCAZEN®-REVEAL trial,” said chairman and chief scientific officer of the company in a statement Tuesday, Dr. George Jackowski, who just last week was awarded the Queen Elizabeth II Diamond Jubilee Medal for his contributions to the Canadian biotech and pharmaceutical industries.
“Both primary and secondary endpoints were met, with the evidence supporting the efficacy of VASCAZEN® in correcting an Omega-3 deficiency and addressing some important CVD risk factors, such as patient lipid profiles.
"The statistically significant elevation in Omega-3 levels, drop in triglycerides, and the elevation of HDL cholesterol, all in eight weeks, evidences the deficiency is being corrected and patients are seeing results."
He further says that the positive data from the trial, which were presented earlier this month at the American Heart Associationʼs Arteriosclerosis, Thrombosis and Vascular Biology (ATVB) 2013 Scientific Sessions, show that Vascazen could be an important treatment option for correcting an Omega-3 deficiency, "thereby reducing CVD risk factors including high triglycerides in patients who do not meet the current criteria for pharmaceutical treatment targeting high triglycerides.”
Indeed, the dual-listed company says its medical food product has carved out a niche, for the dietary management of patients with cardiovascular disease that are deficient in Omega-3 fatty acids - a much broader market than for Lovaza, the first prescription Omega-3 to market, after which Vascazen followed.
Lovaza, which is owned by GlaxoSmithKline, is indicated exclusively for the reduction of "very high" - 500 mg/DL- triglyceride levels in adults.
The Reveal study has also confirmed what Pivotal saw in its earlier open label study in 2011, which identified more than 80 per cent of cardiovascular disease patients as Omega-3 deficient, the company said.
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.
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