Leone Asset Management Inc (PK)【LEON】株式ニュース

Go Epic Health to Begin Next Round of Clinical Studies for Cholesterade®Press Release | 03/21/2018

Leone Asset Management announces that their subsidiary Go Epic Health is beginning their next clinical study for Cholesterade®

St. Petersburg, FL, March 21, 2018 (GLOBE NEWSWIRE) -- James Price, CEO of Go Epic Health, stated, “We are extremely excited to begin the next round of clinical studies on Cholesterade®. When Dr. Cade first created the product he conducted case studies at the University of Florida and had amazing results in the study. Recently, Dr. Richard Goldfarb conducted a proof of concept study to once again prove the efficacy of Cholesterade® on lowering cholesterol and also experienced amazing and similar results as Dr. Cade. The next round of studies will be a much larger scale as well as being conducted in a multi-center program.”

The research study is to validate the use of Cholesterade® to improve lipid profiles of individuals and examine the cardiovascular benefits of this reduction in lipids.

The research study will involve the use of human subjects and thus will need to be in a clinical setting. It will also require prior IRB approval. We intend to use Western IRB for study protocol approval. The study will be conducted in several clinic locations in the Memphis, Tennessee area and will use Cleveland Heart Labs advanced Lipid screen for lab draws and test results.

The genesis of this study is based on a previous case study conducted on Cholesterade® namely - Effect of two Dietary Soluble Fibers on Cholesterol and Triglyceride Concentrations in Human Plasma - which showed robust improvement in Lipid profiles of test subjects within 4 weeks of use including LDL, HDL, Total Cholesterol and Triglycerides.

We want to build on the results of that study and further explore the medium and long-term effects of Cholesterade® on reduction in lipids and improvement in overall lipid profile as a cardio-protective mechanism for improved clinical outcomes in test subjects.

This new proposed study will involve human subjects who will have baseline Total Cholesterol, LDL, HDL, TG and advanced Lipids. These advanced Lipids and Arterial Inflammatory markers have been shown to be elevated in subjects vulnerable to an impending cardiovascular adverse event.

In addition to the standard Lipid profile mentioned above and as tested in the previous study, we will be testing for F2-IsoPs, OxLDL - which correlate with lifestyle concerns. ADMA/SDMA, Microalbumin, hsCRP - which correlate with development of metabolic or cardiovascular disease, Lp-PLA2 Activity, MPO - which correlate with formation of vulnerable plaque and increased risk for an adverse event.

We will also check for advanced Lipid particles - Apolipoprotein B (ApoB) and A1 (ApoA1), Small-Dense LDL (sdLDL), Lipoprotein (a) (Lp(a)) and HDL2b – which address additional risk factors for Cardiovascular disease including the number of atherogenic particles, the size of these particles and the inherent risk of developing CVD.

These labs will be drawn at baseline before the start of the study period. After signing a consent form to be a part of the study protocol, these subjects will then be randomized into the Cholesterade® or Placebo group for a period of 12 months without changing any lipid lowering therapy. An attempt will also be made to keep medication profiles unchanged over the course of the study period.

These subjects will undergo a 3-month, 6-month, 9-month and 12-month follow up clinic visits and have the same labs drawn on each visit.

We will longitudinally follow these patients and also look for cardiovascular outcomes including new onset Diabetes, Hypertension, Cardiovascular event (defined as Unstable Angina, NSTEMI or STEMI) and Ischemic Stroke during the study period.

We will try to propensity match the placebo and treatment groups. We will look to minimize confounding. The Lipid profiles and change in lipid particle values will be statistically evaluated. We will also compare cardiovascular outcomes as defined in the protocol between the placebo and treatment groups.

We will also look at adverse reactions and side effect profile of the product during this research study.

The results will be published in a peer-reviewed journal and be available on PubMed for review and viewing. We expect to validate the findings of the previous case series and add to the value of Cholesterade® by showing improved lab results not only in the standard lipid panel but advanced lipids and inflammatory markers which are more reliable markers of Cardiovascular disease risk. This will put Cholesterade® on the forefront of Cardiovascular disease prevention as an over the counter non-medicinal product and further enhance its market share.

We will also explore the possibility of doing a Meta-analysis of clinical data involving the use of Cholesterade® product in various clinical outcomes. This will evolve as more trials are conducted using the Cholesterade® product.

About Leone Asset Management

Leone Asset Management, Inc., is a multi-national, multi-industry conglomerate with subsidiary companies that operate in Health and Wellness, Infrastructure development and agriculture management. For additional information, visit: www.leoneasset.com.

About Go Epic Health

Go Epic Health, a Leone Asset Management subsidiary, is a nutritional product holding company which owns the intellectual property and worldwide manufacturing and distribution rights to Cholesterade®, a natural cholesterol reducing product created by the late Dr. Robert Cade, creator of Gatorade®. Go Epic Health markets and distributes Cholesterade® as well as other new and innovative consumer goods through the nation's largest retail pharmacy chain stores, drug and health food stores and product specific catalogs. For further information, please visit www.goepichealth.com and www.cholesterade.com.

Forward-Looking Statements Disclosure:

This press release may contain "forward-looking statements" within the meaning of the federal securities laws. In this context, forward-looking statements may address the Company's expected future business and financial performance, and often contain words such as "anticipates," "beliefs," "estimates," "expects," "intends," " plans," "seeks," "will," and other terms with similar meaning. These forward-looking statements by their nature address matter that are, to different degrees, uncertain. Although the Company believes that the assumptions upon which its forward-looking statements based are reasonable, it can provide no assurances that these assumptions will prove to be correct. All forward-looking statements in this press release are expressly qualified by such cautionary statements, risk, and uncertainties, and by reference to the underlying assumptions.

Woody Junot President Go Epic Health (727) 581-1500 wjunot@goepichealth.com