MYOS Clinical Research Study Confirms
Published: Mar 20, 2013
CEDAR KNOLLS, NJ--(Marketwire - March 20, 2013) -
MYO-T12 Product Website
MYO-T12 is the Company's first commercialized product. It is the first clinically demonstrated natural myostatin inhibitor. Myostatin is a naturally occurring regulatory protein which inhibits muscle growth and recovery. Medical literature suggests that lowering myostatin levels has many potential health benefits including an increase in muscle mass, healthy weight management, an increase in energy and the stimulation of muscle healing, as well as helping with sarcopenia, a condition of age-related loss of muscle mass and strength.
"This study serves as an important starting point for MYOS, and a basis for further studies to show the importance of MYO-T12 for improving muscle health," said Glen Fleischer, Chief Executive Officer of MYOS. "Myos is committed to continued investment in research to provide a sound scientific basis for our products. We strongly believe that safe and effective products which improve muscle health will come to be recognized as a pillar in the healthy lifestyles of athletes, fitness enthusiasts, and the broader wellness focused population, potentially including the management of chronic illnesses and muscle weakness from aging."
In this clinical study, 36 healthy human male subjects, aged 18 to 55, were enrolled and randomized into one of three groups receiving either a placebo, 10 grams of MYO-T12 or 30 grams of MYO-T12. Whole blood samples were drawn at multiple intervals, including pre-treatment, as well as 6, 12, 18 and 24 hours after dosing. The study was conducted at an independent national clinical research organization and the blood was analyzed for myostatin by a leading university medical school.
The data showed that subjects had significant variability in pre-treatment baseline myostatin levels across the study population with a mean of 29.7 ng/ml, which is consistent with the levels reported in medical literature [Pawel Szulc, et al. (October 2012). Endocrine and Clinical Correlates of Myostatin Serum Concentration in Men - the STRAMBO Study. J Clin Endocrinol Metab, 97(10):3700-3708. doi: 10.1210/jc.2012-1273]. A larger decrease in myostatin levels from baseline was observed at all time points (6, 12, 18, and 24 hours) following treatment in the 10 gram dosed subjects, and at 18 and 24 hours following treatment in the 30 gram dosed subjects, when compared to the placebo group. Pooled data from the test groups versus placebo group showed a larger drop in myostatin levels from baseline at all times following treatment.
Dr. Louis Aronne, a member of the MYOS board of directors and the Company's Scientific Advisory Board, commented, "We undertook this study to better understand how MYO-T12 affects serum myostatin levels and to gain greater insight into the kinetics of this effect. This work is just the beginning of our efforts to explore the potential value of MYO-T12 as a dietary supplement capable of lowering serum myostatin levels to enhance muscle growth and recovery."
About MYOS Corporation
MYOS is a development 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 demonstrated natural 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 for muscle health. 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 the successful continued research of MYO-T12 and its effects on myostatin inhibition, product and customer demand, market acceptance of our products, the ability to create new products, the ability to achieve a sustainable profitable business, the effect of economic conditions, the ability to protect our intellectual property rights, the continued growth of MYO-X in GNC, Vitamin Shoppe and other specialty retail stores, 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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Stephanie Prince/Jody Burfening