The primary objective of this trial is to assess the efficacy, measured as first-year height velocity, and safety of three different combination regimens of growth hormone and IGF-1 compared to growth hormone alone in the treatment of short stature associated with IGF-1 deficiency. The combination product will be studied in children with short stature not associated with growth hormone deficiency, who also have low IGF-1 levels.
This Phase II study, referred to as MS316, is a randomized clinical trial comparing three different combination regimens to growth hormone alone. The three combination arms each contain a different ratio of IGF-1 to growth hormone. The primary efficacy endpoint is height velocity during the first 12 months of therapy. After evaluation of the primary endpoint, the study will be continued to evaluate long-term effects. Approximately 100 patients will be enrolled in the study. Tercica expects to complete enrollment in mid-2009.
John Scarlett, president and CEO of Tercica, said: “With demonstrated synergies in pre-clinical studies, the combination of growth hormone and IGF-1 could have the potential for several important therapeutic benefits compared to either growth hormone or IGF-1 monotherapy alone for the treatment of patients with short stature.”