Insmed Inc (INSM)

[Christiaan F]

<<There has always been a question regarding TRCA's clinical trials and maybe the EU would ask for additional info. considering the known risks of naked IGF-1.>>

And this new study will not help TRCA's approval process!

First Editor’s Comment: This is the first study comparing 2 doses of GH in short children with SGA and the effect on growth and IGF-I levels. The issue is important since there is a theoretical risk of cancer after prolonged exposure to higher circulating levels of IGF-I and IGF-I/IGFBP3 ratio. This has led to repeated recommendations for the evaluation of circulating IGF-I levels, at least yearly, during GH treatment. The present data document precisely the effect of the 2 most frequently prescribed doses of GH and provide unique data for an appropriate comparison at 6 months of treatment. However, the study does not elucidate the question whether the dose-related increase of IGF values remains the same at a later time, when the high-dose GH does not produce a higher growth rate anymore.
http://www.gghjournal.com/volume22/3/ab04.cfm

CF