ARDANA ANNOUNCES POSITIVE RESULTS IN
PHASE I STUDY OF ORAL GROWTH HORMONE SECRETAGOGUE

Edinburgh, UK; 19 April 2005 : Ardana plc (LSE:ARA) today announces positive results in a Phase I study of its oral Growth Hormone Secretagogue (GHS), EP1572.  

EP1572 is a novel synthetic compound that is orally active and stimulates the secretion of growth hormone (GH) from the patient’s pituitary gland for the treatment of growth hormone disorders (GHD).  Ardana licensed the compound with exclusive worldwide rights, including the right to sub-licence, from Aeterna Zentaris (TSX:AEZ; NASDAQ:AEZS) in 2002.

The Phase I study provides clear evidence that EP1572 is able to induce a rise in growth hormone levels.  The open, randomised, placebo-controlled dose-escalation study involved a total of 36 healthy male volunteers, divided into three groups of 12 volunteers. Nine subjects in each group received a single oral dose of EP1572 - 0.005 mg/kg in the first group, 0.05 mg/kg in the second group and 0.5 mg/kg in the third group - with the other three subjects in each group receiving a placebo. All subjects had been initially checked for their ability to release growth hormone by the intravenous administration of another hormone, growth hormone releasing hormone (GHRH). 

The data show that between 1-2 hours after drug administration there was a large increase in the levels of growth hormone in the blood without any effect on other hormones with the mean GH value being 79.12 ng/ml at the highest dose of EP1572 (p = 0.009), compared to 52.62 ng/ml with GHRH and 3.58 ng/ml for placebo.  In all cases, EP1572 was well-tolerated and no adverse events were reported.

EP1572 is the only orally active growth hormone in development and this presents a major competitive advantage in terms of ease and convenience of delivery, particularly in the treatment of children.  Current treatment is only via injectable delivery.

Additional studies are on-going and in-line with the company’s business strategy, Ardana intends to seek a partner to accelerate development of EP1572 for GHD and the more significant marketing opportunity of cachexia (muscle wasting) associated with chronic disease, maintaining its focus on reproductive health.  In 2004 the global growth hormone market was estimated to be worth $2.3 billion (source: Wood Mackenzie’s ProductView December 2004).

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