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news.AEterna Zentaris and Japanese partner Shionogi & Co have reported positive results for a phase IIa trial with cetrorelix in benign prostatic hyperplasia (BPH) initiated in 2005 in Japan.
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Results showed that cetrorelix, the company’s lead luteinizing hormone-releasing hormone (LHRH) antagonist, was safe and well tolerated at all dosage regimens. Furthermore, Japanese patients responded to cetrorelix with a transient reduction of testosterone concentration in blood, which did not reach or remain at the castration level.
Additionally, none of the dosage regimens tested caused a suppression of PSA levels. Finally, data generated with Japanese patients showed that the bioavailability of cetrorelix was similar to that observed in non-Japanese patients.
On the basis of this study, Shionogi initiated a 300-patient phase IIb study to assess primarily the efficacy of cetrorelix in BPH in Japanese patients.
BPH is characterized by an abnormal benign growth of the prostatic tissues caused by testosterone. Symptoms linked to BPH include pain while urinating and frequent urges to urinate during the night and sometimes, kidney problems. In some cases, if left untreated, BPH may develop into prostate cancer.
Cetrorelix is marketed under the brand name Cetrotide and is used as part of in-vitro fertilization programs in Europe, the US and Japan. It was launched on the market through Merck Serono in the USA, Europe and in several other countries, as well as in Japan through Shionogi.