Ardana PLC
14 February 2007
ARDANA ANNOUNCES FAVOURABLE PRELIMINARY RESULTS FOR TEVERELIX LA IN DEVELOPMENT
FOR PROSTATE CANCER
Edinburgh, UK, 14 February 2007 - Ardana plc (LSE:ARA) today announces
preliminary results from a study in male subjects of its lead development
compound, the GnRH antagonist Teverelix Long Acting (LA). This study, which is
part of the ongoing clinical development of Teverelix LA for the treatment of
advanced prostate cancer, is the first to be completed under a granted
Investigational New Drug (IND) application for Teverelix LA.
The progression of prostate cancer is driven by male sex hormones (androgens)
such as testosterone. It is widely accepted that reducing levels of these
hormones in advanced disease can help slow the growth of the cancer and prolong
survival. The production of testosterone can be reduced either surgically, with
the removal of the testes, or through medicines that affect production of
testosterone. Previous Phase II studies have confirmed that Teverelix LA can
attain and maintain suppression of testosterone to castration levels in patients
with advanced prostate cancer.
This study was designed to establish whether the pharmacokinetics and
subsequently the effectiveness of Teverelix LA in suppressing testosterone
levels is similar in normal weight and obese subjects, an issue raised by the
United States Food and Drug Administration (FDA) at a previously reported
pre-IND meeting held in 2005.
This open-label, Phase I study in males, involved 22 normal weight subjects with
a Body Mass Index (BMI) between 18.5 and 25, and 22 obese subjects with a BMI
greater than 30. All subjects received Teverelix LA administered as a single
subcutaneous injection. The primary endpoint was a comparison between the two
groups of the pharmacokinetics of Teverelix LA, including mean maximum drug
level and area under the curve (a measure of the total amount of drug absorbed
by the body). A comparison of the effects of Teverelix LA on serum testosterone
levels was the key secondary endpoint. Study results provide evidence that, over
an 8-week period, there were no differences between the groups in terms of both
the pharmacokinetics of Teverelix LA and its effect on testosterone suppression.
An additional Phase II study in patients with advanced prostate cancer is
currently ongoing, with results expected in the second quarter of 2007.
Teverelix LA is also in development for the treatment of benign prostatic
hyperplasia and endometriosis.
Dr. Maureen Lindsay, Ardana's CEO, said: 'We are very encouraged by the
progress made in the development of Ardana's long-acting formulation of
Teverelix. This programme of studies continues to support the development of
Teverelix LA as a potential new treatment for prostate cancer, a disease where
new therapies remain a major medical need in a multi-billion dollar market.'
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 built 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 lead products are summarised below:
• Emselex(R), a once a day treatment for the symptoms of overactive bladder
syndrome, which Ardana has exclusive UK marketing and promotion rights and
is being distributed in collaboration with Novartis UK Limited;
• StriantTM 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 confirmed
hypogonadism;
• Teverelix LA, in development for three initial indications (prostate
cancer, benign prostatic hyperplasia and endometriosis);
• Testosterone Cream, a trans dermal testosterone delivery system in
development for the treatment of male hypogonadism, in Phase II trials;
• InvicorpTM, an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe and has been launched in Denmark.
• EP01572 a growth hormone secretagogue in late stage development for the
diagnosis of growth hormone deficiency
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
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