ARDANA ANNOUNCES POSITIVE PRELIMINARY

PHASE II RESULTS FOR TEVERELIX LA

IN PROSTATE CANCER

Edinburgh, UK: 4 September 2007 :  Ardana plc (LSE:ARA) today announces positive preliminary results from a Phase II study in patients with prostate cancer demonstrating a new dose regimen extended to 8 weeks from 4 weeks for its lead development compound, the GnRH antagonist, Teverelix Long-Acting (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 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.  Previous Phase II studies have confirmed that Teverelix LA can attain and maintain suppression of testosterone to castration level for at least 4 weeks in patients with prostate cancer.  This new study has demonstrated a dosage regime that can extend this to at least 8 weeks.

Dr. Maureen Lindsay, Ardana’s CEO said: “We are very encouraged by these positive and very promising preliminary results, which have identified a dose of Teverelix LA that extends the suppression of serum testosterone to below castration level from four weeks to eight weeks or more.”

Study design

This randomised Phase II study involved 38 patients with prostate cancer.  Patients were randomly assigned to one of two dose regimens of Teverelix LA.  20 patients received the higher dose and 18 patients received the lower dose.  The primary endpoint was the duration of suppression of testosterone to below castration level (< 0.5 ng/ml).

The secondary endpoints were the percentage of patients attaining and maintaining medical castration, 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:

Mean testosterone levels in the higher and lower dose groups at baseline were 3.71 ng/ml and 4.3 ng/ml respectively. Suppression of testosterone was attained in both dose groups by Day 3 in 18/20 and 14/18 patients, respectively.

Preliminary data from the higher dose group shows that reduction of testosterone levels to castration level was attained in 19/20 patients.  For these 19 patients, the duration of castration was between 54 and 147 days with 17 patients being castrated for 8 weeks (56 days) or more.

Also noted in the higher dose group was a rapid effect on PSA levels. At Week 4, 14/19 (74%) of patients had normalised PSA (< 4.0 ng/ml).  Mean PSA levels for the group were normalised at 8 weeks. 

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.

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.

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