LEXINGTON, Mass., Nov. 28 IndevusPharmaceuticals, Inc. (Nasdaq: IDEV) today announced positive results from itsPhase II octreotide implant trial in patients with acromegaly, a disordercharacterized by excessive blood levels of growth hormone (GH) and insulin-like growth factor 1 (IGF-1). The implant utilizes the Company's patentedHydron technology to deliver effective levels of octreotide for six months.Octreotide is a synthetic peptide that mimics the natural hormone somatostatinto block release of GH. In the recently completed six-month trial, theoctreotide implant effectively suppressed levels of GH and IGF-1 at ratessimilar to those seen with current FDA approved injectable formulations ofoctreotide. In addition, the drug was well tolerated.
"I am extremely pleased to report the successful completion of ouroctreotide implant trial and we are looking forward to the initiation of ourPhase 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 asix-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 forpeople who suffer from this life-long debilitating condition. In addition,based on the successful results of this trial, we are exploring opportunitiesto expand our octreotide development program to address other indicationswhere injectable formulations of octreotide are currently utilized, includingcarcinoid tumors."
The trial was an open-label study designed to evaluate the pharmacokineticand pharmacodynamic response of octreotide implants in patients withacromegaly. The trial evaluated the release effectiveness of both pre-hydrated and non-hydrated (dry) implants and evaluated the suppression ofgrowth hormone (GH) and insulin-like growth factor 1 (IGF-1). The trialenrolled and evaluated a total of 34 patients who had previously demonstrateda full or partial GH and IGF-1 response to octreotide. Approximately half ofthe patients had a baseline growth hormone of <5 ng/mL on entry into thestudy, indicating that the prior octreotide injections were providing adequatecontrol. In these patients, the octreotide implant successfully maintained GHat this level in 94% of patients. This response rate is similar to the rateseen with Sandostatin(R) LAR(R) (83 to 97%). Approximately 60% of theseimplant trial patients achieved a normal age-adjusted IGF-1 concentration.Sandostatin LAR produces a similar age-adjusted normalization of IGF-1concentrations (51 to 67%).
The remaining patients had entered the trial with baseline GH levels >5ng/mL, and 59% achieved GH suppression to <5 ng/mL and 35% achievedsuppression to <2.5 ng/mL. This response rate is similar to the rate seenfrom partial responders when treated with Sandostatin LAR (32% and 4%respectively).
All enrolled patients completed the six-month trial and there were noserious or severe adverse events reported.
The trial also confirmed by pharmacokinetic analysis that there was nodifference in the predictable, steady release of octreotide from either thepre-hydrated or non-hydrated octreotide implants. The Company intends toutilize the non-hydrated (dry) octreotide implant in its Phase III program.The octreotide implant employs the same patented Hydron technology utilized inthe Company's currently approved and marketed products SUPPRELIN(R) LA andVANTAS(R).
Acromegaly is a chronic hormonal disorder that occurs when a pituitarytumor produces excess growth hormone, or GH. It most commonly affect middle-aged adults, and if untreated, causes enlargement of certain bones, cartilage,muscles, organs and other tissues, leading to serious illness and potentialpremature death. There are approxi