CEDAR KNOLLS, NJ--(Marketwired - February 27, 2014) - MYOS Corporation (OTCBB: MYOS), an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and performance, today announced the initiation of its first clinical study of MYO-T12® in women. The study, led by Stacy Zamuido, Ph.D., Senior Scientist and Director of Research for the Department of Obstetrics and Gynecology at Hackensack University Medical Center, will determine the effect of MYO-T12® on blood chemistry in healthy adult females. The 20-patient clinical trial will also observe the effect of MYO-T12® on body mass index (BMI) and waist circumference in addition to other indices of muscle health.
MYOS expects to report top-line clinical data from this female study in the second half of 2014 and hopes to utilize the results in building a strategy for establishing a platform for additional clinical trials of MYO-T12® in women. MYO-T12®, currently marketed as MYO-X™ "powered by MYO-T12®," is the Company's flagship product and the world's first clinically proven natural myostatin inhibitor.
Robert C. Ashton, Jr., M.D., Chief Medical Officer of MYOS commented, "Millions of active women and those facing age-related loss of muscle known as sarcopenia are seeking safe and effective natural products like MYO-T12® to optimize their health and athletic performance as well as help combat the effects of aging. This study, which is the first conducted with MYO-T12® in women, is an integral step in advancing our robust clinical development strategy. Importantly, we intend to broaden the clinical spectrum of treatment for MYO-T12® and expand our studies to evaluate use of our product in women and for treatment of sarcopenia."
Dr. Zamudio said, "A key factor in maintaining good health throughout the lifespan is muscle strength and function, especially as we age. Positive results from this clinical study of MYO-T12® will offer women of all ages a safe, natural dietary supplement to help them maintain and improve muscle health."
Myostatin is a muscle-secreted growth factor that is known to negatively regulate, or inhibit, muscle growth. Scientific literature suggests that lowering myostatin levels results in increased lean body muscle mass and improved body composition. It has been shown in preclinical studies that myostatin-null mice show hyper-muscularity and resistance to diet-induced liver fat accumulation and insulin resistance.
Additionally, previous clinical studies have demonstrated that MYO-T12® lowers serum myostatin levels in men. Myostatin suppression has been shown to enhance muscle growth and accelerate recovery and healing. The new clinical study involving healthy women is designed to show that MYO-T12® is well tolerated in women and may offer benefits which include improved BMI, and reduced waist circumference.
About Hackensack University Medical Center
HackensackUMC, a nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the county's first hospital, it is the flagship hospital of Hackensack University Health Network, one of the largest health networks in the state comprised of 1,140 beds, nearly 10,000 employees and 2,200 credentialed physicians. HackensackUMC was listed as the number one hospital in New Jersey and one of the top three New York metro area hospitals in the U.S. News & World Report's Best Hospital rankings for 2013-14. It also received 10 national rankings in: Cancer; Cardiology & Heart Surgery; Ear, Nose & Throat; Gastroenterology & GI Surgery; Geriatrics; Neurology & Neurosurgery; Orthopedics; Pulmonology; Urology; and the Joseph M. Sanzari Children's Hospital ranked as one of the Top 50 Best Children's Hospitals for Neurology and Neurosurgery in the 2013-14 Best Children's Hospitals list. The children's hospital is housed with the Donna A. Sanzari Women's Hospital in the Sarkis and Siran Gabrellian Women's and Children's Pavilion, which was designed with The Deirdre Imus Environmental Center using the highest "green building" standards, and was included on the Green Guide's list of Top 10 Green Hospitals in the U.S. HackensackUMC is among Healthgrades® America's Best 100 Hospitals in five different areas -- more than any other hospital in the state, is one of Healthgrades America's 50 Best Hospitals™ for seven years in a row, and received the Healthgrades Distinguished Hospital Award for Clinical Excellence™ 12 years in a row. The medical center has also been named a Leapfrog Top Hospital, and received 22 Gold Seals of Approval™ by the Joint Commission -- more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet® recognized hospital for nursing excellence; receiving its fifth consecutive designation in 2014. HackensackUMC is the Hometown Hospital of the New York Giants and the New York Red Bulls, and remains committed to its community through fundraising and community events. To learn more, visit: www.HackensackUMC.org.
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 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, 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.