Ardana announces successful results in Phase II trial of Teverelix in prostate cancer

Edinburgh, UK, 17 February 2005: Ardana today announces successful results in a Phase II study of the Gonadotrophin Releasing Antagonist (GnRH), Teverelix LA (Long Acting), in patients with advanced prostate cancer.

Prostate Cancer is a malignant tumour in the prostate of men.  Prostate cancer growth is driven by male sex hormones known as androgens.  Reducing levels of these hormones can help slow the growth of the cancer.  The most common androgen is testosterone.  The production of testosterone can be reduced either surgically, with removal of the testicles, or through drugs that affect production of testosterone.  In clinical studies Teverelix has been shown to cause testosterone levels to drop rapidly to castration levels.

In the Phase II trial of 14 patients with advanced prostate cancer, 93% of patients on Teverelix LA showed reduced levels of testosterone equivalent to those of castrated men (<0.5 ng/ml) as early as Day 3 and 100% was achieved within the first week. Testosterone levels were maintained below 0.5ng/ml in all patients for between 4 and 14 weeks.  Duration of these reduced levels following the initial dosing of Teverelix LA was for an average of six weeks.  Teverelix LA was also shown to rapidly reduce and normalise PSA levels (Prostate Specific Antigen), a key marker for disease progression. Ardana’s work to date indicates that the tolerability of Teverelix LA was generally good and no allergic reactions have been recorded.

After skin cancer, prostate cancer is the most common type of cancer in men diagnosed in the US and is the fourth most common cause of cancer related deaths in men in northern Europe. It is estimated that the prostate cancer market was worth $3,716 million in 2004, and is expected to rise to $3,934 million in 2008.

Dr. Maureen Lindsay, Chief Executive of Ardana, said:

“These very encouraging results indicate that we have an exciting compound that has considerable potential not just in the treatment of prostate cancer but in the treatment of several other diseases. With this product in our portfolio we believe that we are well- positioned to become a future leader in reproductive health.”

The data from a second, ongoing Phase II study of Teverelix LA in patients with advanced prostate cancer are expected in the second quarter of 2005. In addition, Teverelix LA is currently in clinical development for other indications such as Benign Prostatic Hyperplasia (BPH), and endometriosis. Data from an on-going Phase II study in patients with BPH is expected by mid 2005.

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