Indevus initiates Phase III acromegaly trial

This trial is designed to test the efficacy, safety and tolerability of the octreotide implant in patients with acromegaly. The implant utilizes the company’s patented Hydron polymer technology to deliver effective levels of octreotide for six months. Octreotide is a synthetic peptide that mimics the natural hormone somatostatin to suppress release of growth hormone (GH).

Approximately 34 clinical sites in six countries are participating in this open-label Phase III trial. Participants in the trial will be randomized in a 3:1 ratio to either the octreotide implant or monthly injections of Sandostatin LAR (S-LAR).

The trial is expected to recruit approximately 140 patients in the US and Europe. Patients must be known responders, having well-maintained GH and insulin-like growth factor 1 (IGF-1) levels, to somatostatin analogs and will be randomized to the octreotide implant or S-LAR. The primary efficacy endpoint of the Phase III trial is the suppression of GH and IGF-1.

Glenn Cooper, chairman and CEO of Indevus, said: “Providing an improved treatment option to individuals who suffer with this serious disease is an important milestone for both our octreotide program and our Hydron polymer technology. We expect that this single, large and well-controlled Phase III trial in acromegaly will serve as the basis for US and international marketing applications.”