The US Patent and Trademark Office (USPTO) has issued a notice of allowance related to Cenestra Health's high-purity omega-3 fatty acid formulations and their methods of use. The patent claims cover a range of high-purity omega-3 formulations including ethyl-ester, free fatty acid and triglyceride forms. In 2010, Cenestra Health was issued US Patent No. 7652068, entitled “Omega-3 Fatty Acid Formulations,” covering its unique 4.1:1 ratio of eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA). The expanded patent range now covers high-purity omega-3 formulations with EPA:DHA ratios between about 3.5 to about 5:1. The patent claims also include methods of use to treat dyslipidemias including hypertriglyceridemia.
“The omega-3 landscape is in the midst of a major paradigm shift toward optimally formulated and very highly concentrated EPA/DHA products. The expanded patent claims allowed by the USPTO represent an important milestone in our scientific efforts as we advance novel investigational drugs into human clinical trials for the treatment of hypertriglyceridemia, central nervous system, and inflammatory disorders,” commented Louis Sanfilippo, MD, a managing director of the company and assistant clinical professor of Psychiatry at the Yale School of Medicine.
Data obtained from third party laboratories support Cenestra Health's expanded range of proprietary formulations by demonstrating unique properties associated with different ratios of EPA:DHA. Preclinical and clinical studies show the combination of high omega-3 concentration and these novel 'EPA:DHA ratio response effects' modulate key inflammatory cytokines, increase nerve growth factors, and lower triglycerides without increasing LDL cholesterol. Cenestra Health is utilizing its biomarker targets and human clinical data to develop safe, new prescription medications for cardiovascular disease, depression and inflammation-based illnesses.
Omega-3-acid ethyl esters represent a class of medications called lipid-regulating agents. Prescription omega-3s are used together with lifestyle changes (i.e., weight loss, diet) to reduce the amount of triglycerides by decreasing the amount of fats made in the liver. The FDA has approved a number of prescription drugs to treat elevated triglycerides, including an omega-3 ethyl ester medication.
Cenestra Health is a privately-held and unleveraged biopharmaceutical company formulates, develops and market “best-in-class” proprietary natural products with applications in the OTC, medical food and pharmaceutical markets.
Omega-3 fatty acids are considered "essential" fatty acids (EFAs) as they are necessary to human health but cannot be produced by the body.