MYOS to Study Synergistic Effects of Myostatin Inhibition on Testosterone-Mediated Muscle Growth; Brigham and Women's Hospital's, a Teaching Affiliate of Harvard Medical School, to Conduct the Study
CEDAR KNOLLS, NJ--(Marketwired - August 15, 2013) -
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Testosterone replacement/supplementation therapy is gaining broad recognition as an effective treatment for hypogonadism in men. One of the most prominent effects of testosterone therapy is improved muscle mass and muscle strength. Augmenting those muscle gains with a safe and effective oral myostatin inhibitor in the form of a dietary supplement may provide an important adjunct to testosterone therapy. MYO-T12 is the Company's flagship product and the world's first clinically proven natural myostatin inhibitor; it is currently marketed as MYO-X™ "Powered by MYO-T12."
The principal investigator conducting the study is Shalender Bhasin, M.D., Harvard Medical School Professor of Medicine, a pre-eminent research physician and endocrinologist who heads the Boston-based Brigham and Women's Hospital Research Program in Men's Health: Aging and Metabolism. He is an internationally recognized expert in men's health, age-related sarcopenia and functional decline, and function-promoting anabolic therapies. He chaired the Endocrine Society's Expert Panel for the development of Guidelines for Testosterone Therapy.
Myostatin is a naturally occurring regulatory protein of the TGF-beta family of growth factors known to negatively regulate, or inhibit, muscle growth. Considerable published literature suggests that lowering myostatin levels results in increased lean body muscle mass and improved body composition. In fact, myostatin-null mice show hyper-muscularity and resistance to diet-induced liver fat accumulation and insulin resistance.
MYOS researchers have been evaluating the possible synergy between androgenic therapy, like testosterone, and myostatin inhibition, as a way to optimize and improve the durability of beneficial effects on muscle that these approaches may have in the treatment of age and disease-related sarcopenia. Sarcopenia represents a syndrome characterized by loss of lean muscle mass and strength which contribute to increased risk of mobility limitation, falls, fractures, and metabolic disorders.
MYOS President and COO, Peter Levy, said, "Our objectives in undertaking this study are to determine the effects of MYO-T12 alone or in combination with testosterone on skeletal muscle and fat mass and further our understanding of the potential role of safe and effective myostatin inhibition in the treatment of conditions like sarcopenia. As an emerging biotherapeutics company, MYOS is committed to investing in research which will broaden our intellectual property portfolio and reinforce our position as a leader in muscle health. We are cautiously optimistic this study may expand the range of therapeutic and dietary products we may offer in the future, and help strengthen the rationale for using MYO-T12 to improve the health and performance of muscle tissue."
Commenting on the study protocols, Dr. Bhasin said, "Recent scientific evidence shows that testosterone increases muscle mass and decreases fat mass in healthy young men and in older men with low testosterone levels. In this pre-clinical study we will evaluate whether co-administration of MYO-T12 and testosterone will result in superior gain in skeletal muscle mass, muscle performance, body composition and metabolism compared to MYO-T12 or testosterone alone."
As a functional food, MYOS has received compelling positive anecdotal reports from many of the thousands MYO-X users who report muscle mass gains, improving Body Mass Index (BMI), fat loss and healthy weight stabilization in people ranging from competitive athletes to those afflicted with sarcopenia.
Bloomberg News, on May 10, 2012, reported: As many as 13.8 million men in the U.S. over the age of 45 have low levels of testosterone, according to a 2006 study in the International Journal of Clinical Practice. The male sex hormone begins to decline after age 30 and tends to drop 1 percent each year. Lower-than-normal levels can lead to a decrease in bone and muscle mass... "In what may become one of the most sought-after lifestyle drugs since the introduction of Pfizer's (PFE) Viagra 14 years ago, new testosterone drugs from Eli Lilly (LLY), Abbott Laboratories (ABT), and other drugmakers are hot. Prescriptions for testosterone replacement therapies have more than doubled since 2006 to 5.6 million last year, according to data compiled by Bloomberg. Sales are expected to triple to $5 billion by 2017, forecasts Global Industry Analysts."
Louis Aronne, M.D., a member of the MYOS Board of Directors and the Scientific Advisory Board, commented, "Positive results from this pre-clinical study will establish a solid foundation for evaluating MYO-T12 as a functional food in human clinical trials as an adjust therapy for muscle related disease such as cachexia and sarcopenia as well as a potential adjunctive treatment for anorexia nervosa, obesity, and potentially Type II diabetes."
About MYOS Corporation
MYOS is a developmental stage company focused on the discovery, development and commercialization of products that improve human muscle health and performance. MYOS is the owner of MYO-T12, 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. For more information on MYO-T12 and to discover why MYOS is known as "The Muscle Company,"™ visit www.myoscorp.com.
The Company's first commercial product MYO-X™, powered by MYO-T12, is distributed by Maximum Human Performance (MHP) and is currently available on popular e-tailer websites including www.mhpstrong.com, www.bodybuilding.com and in specialty retailers including GNC and Vitamin Shoppe and others. MYOS believes that MYO-X, 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 MYO-T12 and its effects on myostatin inhibition, including the study described herein, product and customer demand, the continued growth of repeat purchases, market acceptance of our products, the ability to create new products through research and development, the continued growth in revenue, the ability to generate the forecasted revenue stream and cash flow from sales of MYO-X, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, the continued growth and expansion of MYO-X in GNC, Vitamin Shoppe and other specialty retail stores, the ability to `strengthen our manufacturing relationships and reduce the costs of our products, 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. This product is not intended to diagnose, treat, cure or prevent any disease.
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