|By Marketwired .||
|April 9, 2014 07:35 AM EDT||
CEDAR KNOLLS, NJ -- (Marketwired) -- 04/09/14 -- MYOS Corporation ("MYOS" or the "Company") (OTCBB: 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 initiation of a clinical study of Fortetropin (also known as MYO-T12®) conducted in resistance trained male subjects. The study, being led by Jacob Wilson, Ph.D., CSCS*D, Assistant Professor and Director of the Skeletal Muscle and Sports Nutrition Laboratory of the Department of Health Sciences and Human Performance at The University of Tampa, a world leading muscle physiology laboratory, will study the effects of Fortetropin on increasing skeletal muscle mass and strength in male subjects.
The clinical study of Fortetropin is being conducted with 45 resistance trained male subjects in a 12-week randomized, double-blind, placebo controlled trial and will evaluate various endpoints including skeletal muscle hypertrophy, lean body mass and fat mass and measure changes in strength and perceptual measures on pain and recovery. The study participants will be divided into three groups and undergo supervised training, individualized diet and nutrition assessments and meet with a nutritionist on a regular basis. Body composition will be evaluated using Dual Emissions X-ray Absorptiometry (DEXA) and ultrasonography. The subjects' strength will be assessed by bench and leg press; power will be measured using force platform, cycle ergometry, and a 10 second sprint test. Analogue scales will record study participants' perceptual measures on pain and retrieval. Additionally, blood samples will be collected during the study to establish a basic safety profile and determine the effect of Fortetropin on serum myostatin and other biomarker levels.
Dr. Wilson commented, "I am very excited to conduct this study in our human performance laboratory. Muscle health is one of the key components to total health and well-being for both athletic conditioning and for the overall population particularly as it pertains to maintaining an active, vibrant lifestyle as we age. I look forward to exploring Fortetropin's potential role in improving muscle mass and strength in the trial participants."
Robert Ashton, M.D., Chief Medical Officer of MYOS added, "We believe the University of Tampa clinical study will provide us with additional valuable information to add to our growing body of clinical data for Fortetropin. We are committed to understanding the broad bioactivity of this nutritional supplement in different indications. The initial study results will provide insight into the outcome measures and daily dosing guidelines for Fortetropin."
Dr. Ashton concluded, "We believe Fortetropin has significant therapeutic potential in a much broader population to increase lean muscle mass and strength which has been shown to be beneficial in preventing decline in bone mineral content and bone density, and to aid in the reduction of serum glucose and triglyceride levels and suppress inflammation. This study is an important component of our clinical development strategy as we continue to expand Fortetropin's utility into other muscle-related disorders including age-associated muscle loss, known as sarcopenia. We believe Fortetropin can play a major role in the management of frailty associated with many chronic illnesses as well as in age-management."
MYOS expects to report topline data from the Fortetropin study in the second half of 2014.
About The University of Tampa
The University of Tampa (UT), is a private, co-educational university in Downtown Tampa, Florida, United States. It is accredited by the Southern Association of Colleges and Schools. In 2006, the University celebrated its 75th anniversary. UT offers over 150 undergraduate degree options, along with 12 master's degree programs. The University of Tampa's exercise physiology laboratories are designed for studying human performance, exercise metabolism and cardiovascular and muscle physiology.
The Human Performance Research Lab contains the latest computerized systems for the measurement of oxygen uptake, blood lactate and blood gas analyzers. Electromyography is used to analyze skeletal muscle activation, and accelerometers are used to quantify the rate and velocity of human movement. The lab also houses the most current force plate technology along with computerized Monarch Wingate bikes, capable of measuring power output in real time.
About MYOS Corporation
MYOS is a developmental stage bionutrition and biotherapeutics 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 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 retailer websites including www.mhpstrong.com, www.bodybuilding.com, www.amazon.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 our research and development activities described herein or in our other public filings, 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 market expansion and revenue, the successful entry into new markets, the ability to attract additional investors and increase shareholder value, 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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