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AEterna Zentaris Reports Positive Results with Cetrorelix in BPH,for Japanese Phase 2a Trial

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The completed Phase 2a trial with cetrorelix in BPH was designed to evaluate primarily pharmacokinetics and safety (systemic and local tolerability) in Japanese subjects, whereas evaluation of efficacy was only exploratory.

In this multicenter, placebo-controlled and randomized trial, the sustained release formulation cetrorelix pamoate was administered intramuscularly as single or multiple dosing schedules. A total of 50 patients were included in 5 dosing groups corresponding to single administration of 30 mg, 60 mg or 90 mg cetrorelix and multiple administration of 60 mg and 90 mg, 3 times 8 weeks apart. The observation period was up to 32 weeks in the multiple administration dosing groups.

Results

The pharmacokinetic data generated with Japanese patients showed that the bioavailability of cetrorelix after intramuscular cetrorelix pamoate injection is similar to that observed in non-Japanese patients. Similarly, the Japanese patients responded to cetrorelix with a transient reduction of testosterone concentration in blood, which did not reach or remain at the castration level.

Intramuscular injection of cetrorelix pamoate was safe and well tolerated at all dosages tested, both locally and systemically. None of the dosage regimens tested caused a suppression of PSA levels which is important considering that a treatment-related suppression would prevent the use of this marker for the routine monitoring of BPH patients for the potential development of prostate cancer.

The sizes per dosage group were too small to evaluate efficacy trends for statistical significance.

About Benign Prostatic Hyperplasia

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. BPH affects more
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