The USA's Indevus Pharmaceuticals has reported positive results from a Phase II trial of its octreotide implant in patients with acromegaly, a disorder characterized by excessive blood levels of growth hormone and insulin-like growth factor-1. The implant delivered effective levels of the synthetic peptide, which mimics the natural hormone somatostatin, to block release of GH and IGF-1 over six months, the firm noted.
According to Indevus, approximately half of the patients had a baseline growth hormone of <5ng/mL on entry into the study, indicating that the prior octreotide injections were providing adequate control. In these patients, the octreotide implant successfully maintained GH at this level in 94% of subjects. This rate is similar to that seen with Novartis' Sandostatin [Soma (octreotide)] LAR (83% to 97%). 60% of these implant patients achieved a normal age-adjusted IGF-1 concentration, while Sandostatin LAR produces a similar age-adjusted normalization of IGF-1 concentrations (51% to 67%), Indevus said.
Glenn Cooper, chief executive of the firm, stated that "the market opportunity for a six-month octreotide implant for the treatment of acromegaly is substantial. The results of the trial demonstrate the potential of our octreotide implant, the only once-every-six-month treatment, to improve the treatment options for people who suffer from this life-long debilitating condition. In addition, based on the successful results of this trial, we are exploring opportunities to expand our octreotide development program to address other indications where injectable formulations of octreotide are currently utilized, including carcinoid tumors."
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