CEDAR KNOLLS, NJ--(Marketwired - Mar 27, 2014) - MYOS Corporation (OTCBB: MYOS), an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve human muscle health and performance ("MYOS" or the "Company"), announced today that it will participate in a working group on March 28, 2014 including physicians, researchers, patient groups and the U.S. Food and Drug Administration (FDA) to develop measures of clinical benefit for therapeutic products developed or used to treat sarcopenia. The group, the Aging in Motion (AIM) Coalition, was formed to promote understanding about the importance of improving research efforts and developing innovative treatments in the area of sarcopenia and age-related functional decline. At present, the FDA does not have a policy on sarcopenia and currently there are no drugs approved for this disease indication.
Sarcopenia is the degenerative loss of skeletal muscle mass (0.5 to 1% loss per year after the age of 25), quality and strength associated with aging and is a component of frailty syndrome. Frailty is highly prevalent in elderly people and confers high risk for falls, disability, hospitalization, and mortality. Frailty has been considered a comorbidity synonymous with disability and other characteristics of declining physical function. Scientists and clinicians increasingly recognize that frailty may have a biological basis and could, perhaps, be a distinct clinical syndrome. Addressing sarcopenia and frailty syndrome will be a key challenge in caring for aging baby-boomers.
The AIM Coalition believes patient-reported outcome (PRO) measures are potential endpoints to support regulatory assessment of sarcopenia treatments. PROs may be most relevant for measuring improvement in ambulatory function and quality of life. Currently, according to the FDA, any studies or clinical trials for sarcopenia must demonstrate that a treatment improves how patients with the disease feel, function or survive.
MYOS' Chief Medical Officer Robert Ashton, M.D. noted, "This first meeting of the working group will discuss defining sarcopenia as a disease, advancing performance-based outcome measures like short physical performance battery (SPPB) and Gait Speed and how patient input and PRO measures specifically, may play a role in clinical trials for sarcopenia treatments. The treatment of sarcopenia is an important focus for MYOS. We are eager to work with other companies, doctors and patients on this project and look forward to improving the diagnosis and treatment of people with sarcopenia associated conditions."
As part of its commitment to building an education awareness program around combating sarcopenia, MYOS has taken significant steps to educate the public on the effects and treatment options for sarcopenia. The Company has created an information portal for the benefit of those suffering from sarcopenia. For more information please visit www.sarcopeniacure.com.
About the Aging in Motion Coalition
The Aging in Motion (AIM) Coalition is a diverse group of patient, caregiver, health and aging groups working together to press for greater levels of research and innovation to develop treatments in the area of sarcopenia and age-related functional decline. Initiated by the Alliance for Aging Research, the AIM Coalition members are leading ongoing interactions with clinicians, regulators and policy influencers to overcome obstacles that impede the development and evaluation of promising treatments for sarcopenia and associated functional decline in people as they age. AIM members represent patients, providers, caregivers, consumers, aging Americans, researchers, employers and the health care industry.
With its diverse constituency groups and credible scientific guidance from clinical experts, AIM interacts with the scientific community, physicians who treat older patients, the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and Congressional policymakers to help improve functional strength and independence for a growing number of aging people.
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 Fortetropin™ (also known as 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.