Insmed to Evaluate possible Initiation of stage II Trial for IPLEX(TM) in MMD sufferers with serious Insulin Resistance
RICHMOND, Va., June 25, ’09 /PRNewswire-FirstCall by way of COMTEX information Network/ — Insmed Inc. (Nasdaq: INSM), a biopharmaceutical company, today announced results from its exploratory U.S. stage II clinical trial evaluating IPLEX(TM) (mecasermin rinfabate) in sufferers with myotonic muscular dystrophy (“MMD”). The randomized, double-blind, placebo-controlled stage II trial carried out in 13 centers throughout the U.S. enrolled 69 sufferers with MMD, for any six-month period. As this was an exploratory trial, a major endpoint wasn’t pre-defined. The trial explored measures of endurance, making use of the six-minute walk test, muscle functionality and strength, cognitive function, gastrointestinal function, pain, top quality of life, insulin sensitivity, lipid metabolism, and safety and tolerability of IPLEX(TM).
The results of the trial indicated that IPLEX(TM) didn’t exhibit a statistically considerable betterment in the functional calculate of endurance through the six-minute walk test, muscle function, muscle strength, or top quality of life in any of the lab tests utilized during this study. depending on the restricted quantity of subjects enrolled with considerable impairments in cognitive function, gastrointestinal functionality or pain, Insmed was not able to achieve any conclusions concerning the results of IPLEX(TM) on these endpoints
IPLEX(TM) did, however, demonstrate improvements in standard measures of insulin sensitivity and reductions in fasting glucose, fasting insulin, cholesterol and triglycerides, which is constant while using anticipated metabolic report of insulin-like development factor. Administration of IPLEX(TM) also resulted in anabolic results of greater system mass index and greater amounts of
testosterone. The medicine was perfectly tolerated in MMD subjects and demonstrated a safety report constant with previous research of IPLEX(TM).