Cedar Knolls, NJ (Marketwire) - MYOS Corporation (OTCBB: MYOS), a company focused on the discovery, development and commercialization of muscle health and performance therapeutic products, today announced that it has initiated a broad human clinical research study designed to confirm the unique myostatin modulating activities of its first product, MYO-T12™. The study will also explore other clinical effects of the product on normal healthy subjects.
With a focus on enhanced muscle health through science, MYOS anticipates the clinical study will be completed, and its results announced, later in the fourth quarter of 2012.
Peter Levy, Chief Operations Officer of MYOS, said, "The early clinical experience thus far suggests the unique health and wellness benefits of MYO-T12 and myostatin inhibition. We are optimistic that a well designed clinical study will support new and wider consumer use and future therapeutic applications for MYO-T12's proprietary formulation, as part of MYOS' overall leadership in the advancement of muscle health."
MYO-T12 is the Company's recently launched inaugural product. It is the world's first clinically demonstrated myostatin inhibitor, designed to build lean muscle mass and improve strength and endurance. Myostatin is a natural regulatory protein which acts to inhibit muscle growth and recovery (www.myoscorp.com). Research suggests that reducing myostatin levels has many potential health benefits including an increase in muscle mass, healthy weight management, increasing energy and the stimulation of muscle healing. Sarcopenia is a leading cause of progressive muscle loss in men over 18, and inhibiting myostatin levels can aid in the reduction of sarcopenia.
Louis Aronne, M.D., Clinical Professor of Medicine and Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center, as well as a member of the MYOS Scientific Advisory Board commented, "While there have been claims for many products regarding building of lean muscle mass, it is extremely important to conduct standardized clinical protocols that can demonstrate activity both at the biological level and in terms of key measures of health and well-being. To my knowledge, this is the first broad clinical study of its kind for a myostatin modulator, and I look forward to the results of the program."
"MYOS will continue to invest in the research necessary to fully understand the therapeutic value of MYO-T12 and our other products and the role of myostatin regulation in maximizing muscle health as well as in the treatment of other allied diseases such as sarcopenia, obesity, and Type II Diabetes," added Chief Operations Officer, Peter Levy.
The purpose of this clinical research is to validate and extend the existing research of MYO-T12's inventor, Dr. Carlon Colker, whose technology reduced serum myostatin concentration in the early clinical study of healthy men.
This MYOS study will be conducted in compliance with FDA guidelines and both U.S. and international standards of Good Clinical Practice.
Previous MYO-T12 Clinical Research
The health benefits of the active ingredients in MYO-T12 were clinically evaluated in earlier studies. In one published study, MYO-T12 was tested in ten healthy adult male human subjects while only administering a single 10-gram serving size ("Effect on Serum Myostatin Levels of High-Grade Handled Fertile Egg Yolk Powder" in the Journal of the American College of Nutrition, Volume 28, No.3, Abstract 47; October 2009).
In this earlier study, subjects received a single dose of ten grams of MYO-T12. Results showed an average baseline myostatin level of 27.5pg/ml, which was consistent with the author's established publications of average baseline myostatin levels for men ages 20-55. A second myostatin measurement was drawn 12 hours after dosing demonstrated a decline to 12.6pg/ml, a 46% drop in myostatin from baseline across all ten subjects. Finally, at the 24 to 30-hour time point a mean value of 28.1pg/ml was observed, representing normalization of the mean myostatin concentration.
About MYOS Corporation
MYOS Corporation is a development stage company focused on the discovery, development and commercialization of therapeutic products that improve muscle health and performance (www.myoscorp.com).
MYOS is the owner of MYO-T12®, the world's first clinically demonstrated myostatin inhibitor. Myostatin is a natural regulatory protein, which inhibits muscle growth and recovery. MYO-T12 is manufactured to optimize biological activity, which MYOS believes has the potential to redefine existing standards of physical health and wellness enhancement. For more information on MYO-T12 and to discover why MYOS is known as "The Muscle Company,"™ visit www.myoscorp.com.
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 product and customer demand, market acceptance of our products, the ability to create new products through research and development, the successful completion of the clinical study herein, the successful launch of Myo-X, 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, competition from other providers and products, risks in product development, our ability to raise additional capital to fund continuing operations, and other factors discussed from time to time in the Company's Securities and Exchange Commission filings. The Company undertakes 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.
SOURCE: MYOS Corporation