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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

Maureen Lindsay

Tel: + 44 (0) 131 226 8550

Financial Dynamics

(corporate/financial media relations)

Julia Phillips/John Gilbert

Tel: +44 (0)20 7831 3113


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