The first study of the phase III program will assess an intermittent dosage regimen of cetrorelix as a potential safe and tolerable treatment providing prolonged improvement in benign prostatic hyperplasia (BPH) related signs and symptoms.
“We strongly believe that given its known attributes, cetrorelix has the potential to successfully penetrate a $4 plus billion market,” stated David Mazzo, president and CEO of Aeterna Zentaris.
The primary efficacy endpoint of this first study is absolute change in the International Prostate Symptom Score (IPSS), while safety endpoints include changes in sexual function as well as BPH symptom progression. Other important endpoints consist of plasma levels of testosterone and changes in bone mineral density.
The second study of this phase III program is expected to be initiated in the second half of 2007.