Indevus Reports Positive Results Of Phase II Octreotide Implant Trial
Indevus Pharmaceuticals announced positive results from its Phase II octreotide implant trial in patients with acromegaly, a disorder characterized by excessive blood levels of growth hormone (GH) and insulin- like growth factor 1 (IGF-1). The implant utilizes the Company's patented Hydron technology to deliver effective levels of octreotide for six months. Octreotide is a synthetic peptide that mimics the natural hormone somatostatin to block release of GH. In the recently completed six-month trial, the octreotide implant effectively suppressed levels of GH and IGF-1 at rates similar to those seen with current FDA approved injectable formulations of octreotide. In addition, the drug was well tolerated.
"I am extremely pleased to report the successful completion of our octreotide implant trial and we are looking forward to the initiation of our Phase III program in the first half of 2008," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "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."
The trial was an open-label study designed to evaluate the pharmacokinetic and pharmacodynamic response of octreotide implants in patients with acromegaly. The trial evaluated the release effectiveness of both pre- hydrated and non-hydrated (dry) implants and evaluated the suppression of growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The trial enrolled and evaluated a total of 34 patients who had previously demonstrated a full or partial GH and IGF-1 response to octreotide. Approximately half of the patients had a baseline growth hormone of <5 ng/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 patients. This response rate is similar to the rate seen with Sandostatin LAR (83 to 97%). Approximately 60% of these implant trial patients achieved a normal age-adjusted IGF-1 concentration. Sandostatin LAR produces a similar age-adjusted normalization of IGF-1 concentrations (51 to 67%).
The remaining patients had entered the trial with baseline GH levels >5 ng/mL, and 59% achieved GH suppression to <5 ng/mL and 35% achieved suppression to <2.5 ng/mL. This response rate is similar to the rate seen