By: Tomas Ronolski - AllPennyStocks.com News

Thursday, September 11, 2014

With obesity rates at high levels, it’s not surprising that so many people are told to cut down on fats. The guidance comes with an asterisk, though, as not all fats are bad. In fact, there are fats that are essential to diets to promote healthy brain development and function. Appropriately, these are called Essential Fatty Acids, or EFAs. Omega-3 and Omega-6 are two of the critical EFAs. Without getting to granular as to composition, understand that both come in short-chain and long-chain types, with the long-chain form being the most desirable to maintain homeostatic health. In short, this means that getting Omega-6 from margarine or fried food (short-chain) is not as healthy as getting it from meat or eggs (long-chain). In the big picture, imbalances in EFAs or deficiencies are believed to contribute to brain disorders, such as depression, Attention Deficit Hyperactivity Disorder and even Alzheimer’s. Further, Omega-3 fatty acids, which are a type of unsaturated fatty acid, are thought to reduce inflammation in the body, inflammation that can damage blood vessels and lead to heart disease. Pivotal Therapeutics (OTCQX:PVTTF) (CSE:PVO), is a specialty pharmaceutical company focused on Omega-3 therapies for cardiovascular disease and general health. The company, which has offices in Woodbridge, Ontario, Canada and Boca Raton, Florida, has commercialized two products: prescription-only medical food Vascazen® sold in the United States as a treatment for Omega-3 deficiency in patients with cardiovascular disease (CVD); and Omazen®, a natural health, ultra pure Omega-3 product sold in Canada.

Sales for the first six months of 2014 totaled $126,323, including $73,791 during the second quarter. Revenue was down compared to the year prior periods of $166,831 and $95,189, respectively. For the three months ended June 30, 2014, Pivotal reported a loss of $2.17 million, or $0.02 per common share (which included $491,098 in non-cash stock option expenses) compared to a net loss in last year's second quarter of $721,517, or $0.01 per common share. During the latest quarter, the company engaged healthcare marketing and brand specialist Brandkarma to amplify its sales efforts in the U.S., as well as penning an MOU with ACGT Corp. to contemplate a joint venture distribution agreement for commercialization of Pivotal products in China.

Pivotal has scientific evidence supporting the therapeutic benefit of Vascazen®, which they have presented at leading conferences and that has been published in scientific journals. On Wednesday, the company announced the publication of results of a prospective randomized controlled trial in the U.S. that evaluated the effects of Vascazen® in the correction of Omega-3 deficiency in patients with one or more risk factors associated with CVD and evaluated Vascazen's concomitant effects on these risk factors including triglycerides, VLDL cholesterol, LDL cholesterol, and HDL cholesterol. The data was published in the peer-reviewed journal Molecular and Cellular Biochemistry.

In the trial, titled VASCAZEN-REVEAL, 89 percent of the 655 patients were screened with Omega-3 deficient. After eight weeks of treatment of four capsules of Vascazen per day, patients demonstrated a dramatic improvement in Omega-3 levels and a positive effect on lipid profiles, primarily reduction in triglycerides and higher HDL (good cholesterol) levels. The treatment was also associated with a 30 percent reduction in VLDL cholesterol. VLDL cholesterol isn’t as talked about as LDL and HDL cholesterol, but it contains the highest amount of triglyceride, meaning that high VLDL levels increase a person’s risk of coronary artery disease, which can lead to heart attack and stroke. Importantly, no treatment related adverse events were reported in the trial, with Vascazen being basically as safe as the placebo.

"Clinical evidence continues to highlight Vascazen®'s unique and proprietary Omega-3 formulation and we believe that the publication of this trial represents further peer-reviewed validation of VASCAZEN® as an effective medical food for correcting an Omega-3 deficiency," commented Dr. George Jackowski, Chief Scientific Officer of Pivotal Therapeutics and co-author of the MCB paper, in a statement on Wednesday.

The clinical data is there and now it’s a matter of seeing if Pivotal Therapeutics can overcome the grand challenge faced by many upstarts of garnering physician support to prescribe to patients. There’s certainly no shortage of patients, with the Centers for Disease Control and Prevention saying about 600,000 people die of heart disease in the U.S. each year; that’s 25 percent of all deaths.

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