21st Annual Meeting of the European Association of Urology (EAU),
Paris, 5th - 8th April 2006
Treatment with degarelix results in fast, profound and sustained
reductions in testosterone and prostate-specific antigen (PSA) levels
without a testosterone surge
- Following the presentation today of the results of
the Phase IIb programme with degarelix in prostate cancer, which are
in line with previous promising studies, Ferring Pharmaceuticals
announced the immediate start of Phase III trials(1).
The findings from the international multi-centre trial in 187 men
showed that 100% of those treated with an initial dose of 240mg and a
maintenance dose of 160mg achieved androgen deprivation from day 28
to the full year. Androgen deprivation achieves disease control in
prostate cancer patients.
"Degarelix is one of the first drugs in the emerging novel GnRH
blocker class of treatments for prostate cancer and represents a new
option which builds on many years of experience with effective
hormonal therapies," commented Professor Hein Van Poppel of the
Department of Urology at the University of Gasthuisberg. Leuven,
Belgium. "The results from this trial indicate that degarelix offers
a potentially fast, profound and sustained suppression of
testosterone and PSA, the well-known marker for prostate cancer."
"Prostate cancer is the second leading cause of cancer death among
men and there is an ongoing need for better treatments," explained Dr
Bo-Eric Persson, Director, Medical Sciences, Urology / Oncology for
Ferring Pharmaceuticals. "These results encourage us further that
degarelix has the potential to answer some of these unmet needs in
prostate cancer treatment."
HOW DEGARELIX WORKS
Currently used hormonal treatments for prostate cancer include
GnRH (gonadotrophin releasing hormone) agonists. Unlike degarelix,
these therapies stimulate the natural hormone's receptor on the
pituitary gland. These agents also have a desired clinical effect,
but they stimulate testosterone production before shutting it down.
This initial stimulation of the receptors stimulates
hormone-dependent tumour growth rather than inhibits it, and may lead
to a worsening of cancer symptoms or 'flare'.
Degarelix is designed to target and block the GnRH receptor. This
rapidly prevents the production of testosterone and avoids the surge
of testosterone and risk of flare.
DEGARELIX STUDY FINDINGS
Degarelix was investigated in one multicentre, one-year study in
Europe/South Africa. The study involved the evaluation of initiation
doses of 200mg and 240mg administered subcutaneously followed by
three maintenance doses 80, 120 and 160 mg given every 28 days.
The therapeutic effect was assessed by measuring testosterone and
prostate-specific antigen (PSA) levels. 187 patients (age 52-93,
median 72 years) with histologically confirmed Prostate Cancer and
PSA more than or equal to 2 ng/mL received degarelix subcutaneously
every 28 days.
Among those initially treated with 240mg of degarelix,
testosterone levels of less than or equal to 0.5 ng/mL were achieved
in 92% of patients at Day 3 and 95% of patients at Day 28 compared
with 88% at Day 3 and 86% at Day 28 for those administered with a
From Day 28 until Day 364, 100% of patients receiving maintenance
doses of 160 mg achieved testosterone levels of less than or equal to
0.5 ng/mL at each monthly visit, compared with 96% of those
receiving 120 mg and 92% of those receiving maintenance doses of 80
No evidence of testosterone surge was detected. PSA levels were
reduced by 90% 8 weeks after initiation of therapy, by 94% after 12
weeks and by 96% after 24 weeks of treatment.
Notes for editors
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 197,800 new cases,
126,900 in the 5 biggest European countries and 30,400 new cases in
Japan were estimated in 2003. In 2002 GLOBOCAN cancer database
reported 542,909 new cases of prostate cancer diagnosed worldwide and
204,000 deaths due to this disease.
Current Treatment Options for Prostate Cancer
Current therapeutic options include surgery, radiation therapy,
hormonal manipulation therapy or a combination of these. The approach
to treatment is influenced by the patient's age, stage of cancer and
co-existing medical problems, though no agreed treatment pathway
exists and treatment patterns vary in different countries.
Several different hormonal approaches are available for prostate
cancer including bilateral orchiectomy (surgical removal of the
testicles), GnRH analogues and anti-androgens.
GnRH blockers versus agonists
Naturally occurring GnRH binds to the GnRH receptor on cells in
the pituitary gland, triggering the production of luteinising hormone
(LH), which subsequently stimulates the production of testosterone.
Both GnRH agonists and blockers bind to this same receptor target.
Agonists, however, work initially by stimulating release of LH and
hence testosterone production meaning there is surge in testosterone
at the start of treatment leading to characteristic flare responses
in symptoms and tumour growth. Meanwhile blockers, like degarelix,
directly prevent the release of LH, which means testosterone
suppression is fast and profound without a surge. In addition, with
blockers there is no need to administer a second hormonal agent,
called an anti-androgen, normally used to combat the flare responses
that accompany the GnRH agonist usage.
Degarelix is a GnRH blocker, a synthetic peptide modelled on the
body's own gonadotrophin-releasing hormone.
1. Van Poppel, de la Rosette, Persson, Jensen, Olesen, A one year,
multicentre, randomised study of degarelix, a gonadotrophin-releasing
hormone (GnRH) receptor block in prostate cancer patients. 21st
Annual Meeting of the European Association of Urology (EAU), Paris,
5th - 8th April 2006.
Ferring is a Swiss-based research driven, speciality
biopharmaceutical group active in global markets. The company
identifies, develops and markets innovative products in the areas of
endocrinology, gastroenterology, gynaecology, infertility and
urology. 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.ferring.com
ots Originaltext: Ferring Pharmaceuticals