MYOS Corporation Announces Statistically Significant Top-Line Clinical Data Demonstrating Fortetropin's(TM) Anti-Inflammatory BioTherapeutic Properties
Daily Use of Fortetropin Significantly Decreases Inflammatory Cytokine Levels; Company to Explore a Much Broader Range of Opportunities for Fortetropin as a Treatment Option for Inflammatory Conditions
CEDAR KNOLLS, NJ -- (Marketwired) -- 10/30/14 -- 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 new data from its clinical trial conducted at The University of Tampa which examined the effects of Fortetropin™ in conjunction with modest resistance training in average men. Earlier this year MYOS reported positive data confirming that the use of Fortetropin significantly increases muscle size and lean body mass in recreationally-exercised male subjects. Further analysis of serum biomarkers from subjects in the clinical trial revealed that daily use of Fortetropin significantly decreases inflammatory cytokine levels which demonstrates Fortetropin's promising anti-inflammatory biotherapeutic properties.
The double-blind, placebo-controlled trial divided forty-five participants into placebo, 6.6 grams and 19.8 grams Fortetropin daily dosing arms for a period of 12 weeks. In addition to measuring skeletal muscle growth, lean body mass, strength, and power, the study protocol also called for a series of serum panel evaluations including IFN-γ inflammatory cytokine screening. For subjects in the placebo group, no statistically significant changes in serum levels of IFN-γ were noted. However, subjects in both Fortetropin daily dosing arms experienced statistically significant decreases (p < 0.05) in serum levels of the IFN-γ inflammatory cytokine. IFN-γ is recognized as a signature pro-inflammatory cytokine protein that plays a central role in inflammation and autoimmune diseases. Excess levels of inflammatory cytokines are associated with muscle-wasting diseases such as sarcopenia and cachexia.
Robert Ashton, M.D., Chief Medical Officer of MYOS, commented, "We have closely monitored the consumer experience with Fortetropin, particularly in the sports nutrition and body building communities and have been struck by the high frequency of reports of improvement of symptoms associated with chronic inflammatory conditions. We believe there is a close association between the myostatin regulatory system and the inflammatory response to injury and are greatly encouraged by this intriguing clinical data revealing a significant reduction of IFN-γ cytokine levels resulting from daily use of Fortetropin. This data has important implications for potential treatment options in treating diseases such as myofibrositis, fibromyalgia and other inflammatory conditions."
Dr. Ashton continued, "The effect on the important inflammation biomarker also demonstrates that Fortetropin reduces another key factor in sarcopenia and cachexia. This new data may represent a secondary mechanism through which our product may improve MYOS' therapeutic areas of focus. The broader implications of a safe, orally-active product which builds muscle and reduces inflammation will be the focus of our ongoing research."
MYOS expects to publish full details of the serum analysis on the study participants' IFN-γ inflammatory cytokine levels at scientific congresses and/or peer-reviewed journals over 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 and inflammatory cytokine levels, including our research and development activities described herein, product and customer demand, the continued growth of repeat purchases, market acceptance of our existing and future products, the ability to create new products through research and development, the continued growth in market expansion and 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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Source: MYOS Corporation
Released October 30, 2014