Dosing study with degarelix, a novel gonadotrophin-releasing hormone (GnRH) receptor blocker, shows optimum efficacy at higher doses

The phase II dose-escalating study, presented for the first time today shows promising prospects for the use of Ferring's degarelix in the treatment of prostate cancer.(1) Based on these encouraging findings, degarelix is moving forward towards phase III clinical trials.

The multi-centre, randomised trial in 172 men, aged 48-89, tested the efficacy of degarelix by monitoring levels of testosterone (T) and prostate-specific antigen (PSA) in patients treated with doses between 120mg and 320mg at concentrations between 20 to 60 mg/mL. 169 patients (98 per cent) were evaluated at 28 days, with no patients withdrawing from the study due to side effects. The effects of degarelix were found to be dependent on dose and concentration. The best response was achieved by an initial dose of 240 mg (40mg/mL) such that 96% of the patients had T levels less than or equal to 0.5 ng/mL at day 3 and at day 28.

"The optimum dose in the study showed that degarelix created fast, profound and sustained suppression of testosterone production," commented Dr Tammela, Consultant Urologist, Tampere, Finland. "Blocking the body's production of testosterone with degarelix may represent benefits for patients. Degarelix appears to avoid problems traditionally associated with hormonal treatment, such as symptoms associated with the initial testosterone surge and severe flare of disease."

The results presented today support positive efficacy and safety results seen from earlier phase II research on degarelix, presented at SIU in September 2004.(2)

"The results of this trial play a key role for planning the late-stage full development of degarelix," explained Dr Bo-Eric Persson, Director, Medical Sciences, Urology / Oncology for Ferring Pharmaceuticals, makers of the new compound.

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