Statistically significant top-line clinical data demonstrating Fortetropin’s anti-inflammatory biotherapeutic properties reported
MYOS Corporation, an emerging biotherapeutics and bionutrition company focused on the discovery, development and commercialization of products that improve muscle health and performance, has announced new data from its clinical trial conducted at The University of Tampa which examined the effects of FortetropinTM in conjunction with modest resistance training in average men. Earlier this year MYOS reported positive data confirming that the use of Fortetropin significantly increases muscle size and lean body mass in recreationally-exercised male subjects. Further analysis of serum biomarkers from subjects in the clinical trial revealed that daily use of Fortetropin significantly decreases inflammatory cytokine levels which demonstrates Fortetropin’s promising anti-inflammatory biotherapeutic properties.
The double-blind, placebo-controlled trial divided forty-five participants into placebo, 6.6 grams and 19.8 grams Fortetropin daily dosing arms for a period of 12 weeks. In addition to measuring skeletal muscle growth, lean body mass, strength, and power, the study protocol also called for a series of serum panel evaluations including IFN-? inflammatory cytokine screening. For subjects in the placebo group, no statistically significant changes in serum levels of IFN-? were noted. However, subjects in both Fortetropin daily dosing arms experienced statistically significant decreases (p < 0.05) in serum levels of the IFN-? inflammatory cytokine. IFN-? is recognized as a signature pro-inflammatory cytokine protein that plays a central role in inflammation and autoimmune diseases. Excess levels of inflammatory cytokines are associated with muscle-wasting diseases such as sarcopenia and cachexia.
Robert Ashton, M.D., Chief Medical Officer of MYOS, commented, “We have closely monitored the consumer experience with Fortetropin, particularly in the sports nutrition and body building communities and have been struck by the high frequency of reports of improvement of symptoms associated with chronic inflammatory conditions. We believe there is a close association between the myostatin regulatory system and the inflammatory response to injury and are greatly encouraged by this intriguing clinical data revealing a significant reduction of IFN-? cytokine levels resulting from daily use of Fortetropin. This data has important implications for potential treatment options in treating diseases such as myofibrositis, fibromyalgia and other inflammatory conditions.”
Dr. Ashton continued, “The effect on the important inflammation biomarker also demonstrates that Fortetropin reduces another key factor in sarcopenia and cachexia. This new data may represent a secondary mechanism through which our product may improve MYOS’ therapeutic areas of focus. The broader implications of a safe, orally-active product which builds muscle and reduces inflammation will be the focus of our ongoing research.”
MYOS expects to publish full details of the serum analysis on the study participants’ IFN-? inflammatory cytokine levels at scientific congresses and/or peer-reviewed journals over the coming months.
Source: MYOS Corporation