MYOS Corporation Announces Positive Safety Data Demonstrating Fortetropin's™ Lack of Adverse Effect on Serum Lipids and Cholesterol Levels
Daily Use of Fortetropin Does Not Adversely Affect Cholesterol, HDL or Triglycerides; Company Announces New Data From The University of Tampa Clinical Data Conducted in 1H 2014
CEDAR KNOLLS, NJ--(Marketwired - Nov 4, 2014) - MYOS Corporation ("MYOS" or the "Company") (NASDAQ: MYOS), an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and performance, announced today the positive results of lipid serum safety studies, which demonstrate that daily use of Fortetropin™ at recommended and three times the recommended dose has no adverse lipid effect and does not adversely affect cholesterol, HDL or triglyceride levels.
The lipid panel protocol was part of the Company's double-blind, placebo-controlled clinical study conducted earlier this year at The University of Tampa, which demonstrated that the use of Fortetropin significantly increases muscle size and lean body mass in recreationally trained male subjects. The trial examined the effects of Fortetropin in conjunction with modest resistance training in average men. Serum sample collection was completed for all subjects during the 12-week study. The study divided the participants into placebo, 6.6 gram and 19.8 gram Fortetropin daily dosing arms. After 12-weeks of daily consumption at both the low and higher doses of Fortetropin there was no change in participant lipid profiles.
Robert Ashton, M.D., Chief Medical Officer of MYOS, commented, "The source of active proteins and lipids in Fortetropin is fertilized chicken egg yolk, which is well known as one of the most nutritionally dense, natural foods available. There have been numerous published nutrition and serum lipid studies confirming that daily dietary consumption of egg does not change lipid profiles, but unfortunately, there is a general misconception that it does."
Dr. Ashton continued, "In an effort to dispel this misconception, we specifically studied serum lipid profiles in the University of Tampa clinical trial protocol to continue to build on our growing body of data that demonstrates that the consumption of an egg-derived product does not raise cholesterol levels. As we anticipated, the study's serum panel results showed that Fortetropin had no adverse effects on participants' lipid profiles either during or after the study."
None of the participants in the study's active arms saw any elevation in their total cholesterol or triglyceride levels or any decline in their HDL levels. This outcome demonstrates that use of Fortetropin does not negatively affect cholesterol at low or high doses. The lipid panel results confirmed that daily use of Fortetropin does not have any adverse effect on serum lipids.
MYOS expects to submit abstracts with the full data set of the lipid serum analysis related to use of Fortetropin for presentation at scientific congresses and/or peer-reviewed journals in the coming months.
About MYOS Corporation
MYOS is an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and function essential to the management of sarcopenia, cachexia and degenerative muscle diseases. MYOS is the owner of Fortetropin™, the first clinically proven natural myostatin inhibitor. Myostatin is a natural regulatory protein, which inhibits muscle growth and recovery. Medical literature suggests that lowering myostatin levels has many potential health benefits including increased muscle mass, healthy weight management, improved energy levels, stimulation of muscle healing as well as treating sarcopenia, a condition of age-related loss of muscle mass. To discover why MYOS is known as "The Muscle Company,"™ visit www.myoscorp.com.
The Company's first commercial product containing Fortetropin (MYO-T12), is distributed by Maximum Human Performance (MHP) under the brand name MYO-X® and is currently available on popular retailer websites including http://mhpstrong.com, www.bodybuilding.com, www.amazon.com and in specialty retailers including GNC and Vitamin Shoppe and others. MYOS believes that Fortetropin, as well as future products it envisions, will redefine existing standards for muscle health.
Any statements in this release that are not historical facts are forward-looking statements. Actual results may differ materially from those projected or implied in any forward-looking statements. Such statements involve risks and uncertainties, including but not limited to those relating to the successful continued research of Fortetropin™ and its effects on myostatin inhibition, inflammatory cytokine levels and cholesterol levels, including our research and development activities described herein, customer demand for our products, the continued growth of repeat purchases, market acceptance of our existing and future products, the ability to create new products through research and development, growth in our revenue, the successful entry into new markets including the age management market, the ability to successfully launch our own core branded products, the ability to collect our accounts receivable from our distributors, the ability to attract additional investors and increase shareholder value, the ability to generate the forecasted revenue stream and cash flow from sales of Fortetropin and MYO-X®, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, the ability to maintain and expand our manufacturing capabilities and reduce the costs of our products, the ability to comply with NASDAQ's continuing listing standards, competition from other providers and products, risks in product development, our ability to raise capital to fund continuing operations, and other factors discussed from time to time in our Securities and Exchange Commission filings. We undertake no obligation to update or revise any forward-looking statement for events or circumstances after the date on which such statement is made except as required by law.
These statements have not been evaluated by the Food and Drug Administration. Our products are not intended to diagnose, treat, cure or prevent any disease.
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Released November 4, 2014