ARDANA ANNOUNCES PRELIMINARY

PHASE II REPEAT DOSE RESULTS FOR TEVERELIX LA

IN PROSTATE CANCER

Edinburgh, UK: 9 April 2008 :  Ardana plc (LSE:ARA) today announces preliminary results from a Phase II repeat dose study of its lead development compound, the GnRH antagonist Teverelix LA (Long-Acting), in patients with prostate cancer demonstrating testosterone suppression for 28 weeks using an alternative formulation for the first time.

Previous Phase II studies have confirmed that Teverelix LA can attain and maintain suppression of testosterone to castration level for up to eight weeks in patients with prostate cancer.  This new study, using a one month dosing regime repeated every four weeks up to the twenty fourth week, achieved results consistent with those previously announced.  The study utilised an alternative lyophilised formulation offering improvements over the existing powder fill formulation such as process scalability, product stability and potentially lower costs of production.

Dr. Huw Jones, Ardana’s CEO said: "We are encouraged by these results using an alternative formulation of Teverelix LA. This is the first time this formulation has been used in a clinical setting and it has produced good results. The lyophilised formulation has a number of potential advantages which can be used in the further development of Teverelix."

Study design

This randomised Phase II study involved forty patients with prostate cancer.  It was a single arm study where all subjects received initial loading doses of Teverelix LA and then a single repeat dose on Day 28 and every 28 days thereafter up to Week 24.  The primary endpoint was the suppression of testosterone to below castration level (< 0.5 ng/ml).

The secondary endpoints were the effects on prostate specific antigen (PSA), a commonly used serum marker for prostate cancer, the effects on luteinizing hormone (LH) and the local and systemic tolerability of Teverelix LA.

Preliminary study results:

Testosterone levels at baseline were 3.74 ng/ml.  Suppression in testosterone was attained within two days of dosing to a median value of 0.40 ng/ml.  Median testosterone values remained at or below the castration threshold of 0.5 ng/ml from two weeks following the first injection of Teverelix LA until the end of the study at week 28.

Mean PSA levels were reduced by approximately 75% within 4 weeks of the first injection of Teverelix  LA.  The suppression of PSA follows the suppression of testosterone in patients and also appears to be maintained throughout the 28 week study.

Steady state Teverelix LA plasma levels were achieved within four weeks of dosing.  The product appears to continue to be well tolerated and there was no evidence of immunogenicity.   

Following review of the all the results to date, including the results of this repeat dose study using the alternative lyophilised drug product and the success of the eight week dose regimen announced in September 2007, Ardana is finalising the prostate cancer development plan for Teverelix LA.

After skin cancer, prostate cancer is the most common type of cancer diagnosed in men in the USA and is the fourth most common cause of cancer related deaths in men in northern Europe.  It is estimated1 that the prostate cancer market was worth over $4.1 billion in 2005 and is expected to grow to $4.2 billion in 2010. 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 stage disease can help slow the growth of the cancer and prolong survival.  The production of testosterone can be reduced surgically by the removal of the testes, or through medicines that affect the production of testosterone.

In addition to prostate cancer, Ardana is developing Teverelix LA for two other indications – benign prostatic hyperplasia (BPH) (Phase II) and endometriosis (Phase I). 

1 Wood Mackenzie dataview.

For more information contact:

For further information please see www.ardana.co.uk

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