Research Update
Ardana PLC
07 September 2006
ARDANA ANNOUNCES PRELIMINARY POSITIVE PHASE I RESULTS OF TEVERELIX LA FOR THE
TREATMENT OF ENDOMETRIOSIS
Edinburgh, UK: 7 September 2006: Ardana plc (LSE:ARA), the pharmaceutical
company focused on improving human reproductive health, today announces
preliminary results of a Phase I study of the Gonadotrophin Releasing Hormone
(GnRH) Antagonist, Teverelix LA (Long Acting) in healthy female subjects.
Endometriosis arises in pre-menopausal woman when the lining of the womb
(endometrium) grows outside the uterus, often in the pelvic cavity. Symptoms
associated with endometriosis include cyclical or chronic pelvic pain, heavy
periods and infertility. It is well documented that endometriosis is a hormone
sensitive condition and a reduction in estrogen levels causes a shrinkage of the
endometriotic lesions and an improvement in symptoms. Current treatment options
include GnRH agonists. However this class of compounds is associated with side
effects, similar to menopausal symptoms, such as hot flushes, reduced libido and
loss of bone density, due to the reduction in estrogen to those levels seen in
post-menopausal women.
In a previous clinical study of two dose-regimens, different from those
investigated in this study; Teverelix LA has been shown to reduce estrogen
levels rapidly and in a dose-dependent manner.
Preliminary data from this Phase I, randomised, single-blind, placebo-controlled
study of a single subcutaneous injection of Teverelix LA, at one of two doses to
24 healthy female subjects, indicates that Teverelix LA can reduce estrogen
levels to a desired level at the lower end of the normal range which should help
to avoid menopausal symptoms. In this study estrogen levels were reduced to
average concentrations over a period of 8 weeks of 40.5 pg/ml and 49.0 pg/ml
respectively vs. 88.8 pg/ml for placebo.
The effect of Teverelix LA on certain bone absorption markers such as serum
telopeptides and urine deoxypyridinoline were also investigated in the study. On
the basis of the available data these markers appear unaffected by Teverelix
LA..
Additional data analysis is ongoing and a complete data set is expected by the
end of 2006.
This study provides data to support the further development of Teverelix LA in
endometriosis and a Phase II study is currently planned to start by the end of
2006.
Dr Maureen Lindsay, CEO of Ardana said 'The results from this study confirm that
Teverelix LA is not only a potential treatment for male indications (prostate
cancer and benign prostate hyperplasia) for which we have previously reported
proof-of-concept Phase II results but is also a potential drug for female
indications that respond to oestrogen suppression, such as endometriosis and
eventually fibromyomas of the uterus, both conditions with an unmet medical
need.'
It has been estimated that in 2005, there were approximately 17 million cases of
endometriosis in the seven major pharmaceutical markets (US, Japan, France,
Germany, Italy, Spain and the UK) of which approximately 3.9 million cases were
diagnosed.
For more information contact:
Ardana Financial Dynamics
Maureen Lindsay (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert
Tel: +44 (0)20 7831 3113
About Ardana
Ardana plc is a pharmaceutical company focused on the discovery, development and
marketing of innovative products to improve human reproductive health, a $25.5
billion market.
Since its foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology in-licensing and
outlicensing to maintain a robust pipeline.
Ardana's four lead products are summarised below:
• Striant(TM) SR, a testosterone replacement therapy that has been launched by
Ardana through its own sales force in the UK and through marketing partners
in certain European countries, as a treatment for men with hypogonadism;
• Teverelix LA, in development for three initial indications (prostate
cancer, BPH and endometriosis);
• Testosterone Cream, a trans dermal testosterone delivery system in
development for the treatment of male hypogonadism, in Phase II trials;
• Invicorp, an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe.
In addition, Ardana has a strong portfolio of follow-on products in development.
Ardana is listed on the Main Market of the London Stock Exchange.
For further information please see www.ardana.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange