Eterna Zentaris Inc announced statistically significant positive results from a randomized, double-blind, placebo-controlled phase II trial designed to evaluate different dosage regimens of a depot formulation of cetrorelix, a luteinizing hormone-releasing hormone (LHRH) antagonist, in 250 patients with symptomatic benign prostatic hyperplasia (BPH).
These new data demonstrate a dose-dependent, durable and statistically significant (p less than 0.001) improvement of clinical symptoms characteristic of BPH, including IPSS (International Prostate Symptom Score), at all dosages except the lowest, as well as an excellent safety and tolerability profile. These positive results are consistent with data from earlier studies and provide the basis for further development of cetrorelix in BPH through collaboration with Solvay Pharmaceuticals and Shionogi/Nippon Kayaku, an official release said.
"We are very excited about the positive results from this new phase II trial, the last one from a broad seven-study phase II programme evaluating cetrorelix in a combination of indications, and believe it provides strong evidence for the efficacy and safety of cetrorelix in BPH, endometriosis and myoma," said Prof. Jürgen Engel, executive vice president, Global R&D and COO at Eterna Zentaris. He added, "These results, in our opinion, compare very favorably to currently marketed therapies for BPH, which require daily administration. We look forward to continued advancement of this program by our development and marketing partners worldwide, and the initiation of pivotal programs on cetrorelix, including in BPH."
"The successful completion of this latest trial is a remarkable achievement and confirms the excellent partnership we have built with Eterna Zentaris. We believe that the results of the extensive phase II programme will now allow us to finalize the development plans for the compound," stated Dr. Werner Cautreels, Solvay Pharmaceuticals' Global Head of R&D.
Benign prostate hyperplasia is characterized by an abnormal, but not malignant, testosterone-mediated growth of prostate tissue. BPH is estimated to affect approximately 33 million men over 60 years of age. In 2004, the amount spent on drug treatment for this condition is expected to be around US$1.8 billion.
Eterna Zentaris Inc is a biopharmaceutical company focused in oncology and endocrine therapy.