Positive Phase III Data Unveiled For New GnRH Blocker Degarelix - Degarelix Suppressed Testosterone Within Three Days In 96% Of Patients

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 18 Jun 2008 - 2:00 PST

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Data from a Phase III study which demonstrated that the investigational GnRH blocker, degarelix, produced a significant reduction in levels of testosterone , within three days in more than 96% of study patients2 was discussed during the Late Breaking Science Forum at the 2008 Annual Meeting of the American Urological Association (AUA).

The new data, originally presented at the 23rd Annual European Association of Urology Congress in Milan , show that degarelix provided a fast effect on testosterone levels, close to the immediate effect achieved with surgery (orchidectomy).2,

The phase III study compared monthly administration of degarelix with monthly LHRH agonist leuprolide's 7.5 mg in a 12-month randomized, open-label, parallel-group study in prostate cancer (PCa) patients. In comparison to leuprolide, degarelix suppressed serum testosterone and Prostate Specific Antigen (PSA) faster. In addition, degarelix was able to sustain these low levels during the entire 12 month study.2

By day 3 of the study, testosterone levels were suppressed to ≤ 0.5ng/mL in 96.1% of patients in the degarelix arms of the study compared to 0% in the leuprolide arm. By day 14 100% of patients in the degarelix arms achieved suppression of testosterone levels at ≤0.5ng/mL compared to 18.2% in the leuprolide arm.2

After 14 days of treatment, PSA levels had declined in the degarelix treated patients by a median of 64%, while patients who were administered leuprolide saw an 18% decline. Both treatments were well tolerated and showed similar side effect profiles.

"Orchidectomy has long been the gold standard for achieving immediate and sustained androgen deprivation; however, patients are subjected to the physical and psychological adverse effects of surgical castration," commented Dr. Neal Shore, a practicing Urologist from South Carolina "A non-surgical treatment, with clinical equivalency, that accomplishes the same rapid suppression of testosterone would be a very welcome advancement for prostate cancer patients."

Degarelix went through an extensive clinical program of more than 20 studies. All studies have found degarelix to be safe, well tolerated and with no evidence of systemic allergic reactions.2, ,

Main Adverse Events

The most frequently reported adverse events in the phase III trial include (incidence ≥ 5%):

-- Hot flushes: Degarelix 26% vs Leuprolide 21%
-- Weight increased: Degarelix 9% vs Leuprolide 12%
-- ALT > 3 ULN: Degarelix 7% vs Leuprolide 6%)
-- Back pain: Degarelix 6% vs Leuprolide 8%
-- Hypertension : Degarelix 6% vs vs Leuprolide 4%
-- Constipation: Degarelix 5% vs Leuprolide 5%
-- Chills: Degarelix 5% vs Leuprolide 0%
-- Joint pains : Degarelix 5% vs Leuprolide 9%
-- Urinary tract infection: Degarelix 5% vs Leuprolide 9%
-- Injection site reactions : Degarelix 35% vs Leuprolide <1%
-- Most of the Degarelix injection reactions occurred in the beginning of therapy (initiation dose: 34%, maintenance dose: 4%)

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 186,320 new cases were estimated for 2008, with a mortality rate of 28,660. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.

About degarelix

Degarelix is a GnRH blocker currently being developed for prostate cancer. Ferring submitted a New Drug Application (NDA) to the FDA and EMEA in February 2008.

About Ferring

Ferring is a Swiss-based, research driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynecology, and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit www.ferringusa.com

1 - Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28
2 - Klotz L, Boccon-Gibod L, Shore N, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK, Schroder F; Degarelix in a 12-month randomized, open-label, parallel-group phase III study in prostate cancer patients: presented during the Late Breaking Science Forum at the AUA Annual Meeting, Orlando, USA 2008
3 - Boccon-Gibod L, Klotz L, Schröder FH, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot 7.5 mg in a 12-month randomised, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008.
4 - Nielsen S, Connolly M, Persson B, Variation between countries in the perceived use of antiandrogens to prevent flare symptoms: results of a comprehensive survey. Abstract 539 presented at the 23rd EAU Congress, Milan, Italy, 2008
5 - Gittelman M, Pommerville P, Persson B, Olesen T, One-year North American multicentre, randomized dose-finding study of degarelix, a gonadotropin-releasing hormone (GnRH) receptor blocker, in prostate cancer patients. Poster presented at 1st EMUC, Barcelona, 2-4 Nov 2007.
6 - Tammela T, Iversen P, Johansson J, Persson B, Jensen J, Olesen T. Degarelix-a phase II multicentre, randomised dose escalating study testing a novel GnRH receptor blocker in prostate cancer patients (Abstract No. 904) European Urology Supplements 4 (2005) No.3, pp 228.