ARDANA COMMENCES PHASE III REGISTRATION TRIAL FOR ITS

ORAL GROWTH HORMONE SECRETAGOGUE DIAGNOSTIC

Edinburgh, UK: 8 August 2007 :  Ardana plc (LSE:ARA) today announces the commencement in the USA of a planned pivotal registration study of its oral growth hormone secretagogue (GHS) ARD-07 which is in development for the diagnosis of growth hormone deficiency in adults.  The first patient has now been enrolled in the study.

Results from the study are expected in the second half of 2007 and the Company anticipates filing for registration at the end of the year with a possible launch in 2008.  Ardana believes that GHS’ oral formulation has the potential to give clinicians a simpler and more effective test for growth hormone deficiency.

This phase III study is a multi-centre, randomized, cross-over study investigating the safety and effectiveness of oral GHS as a Growth Hormone (GH) stimulation test compared to intravenous L-Arginine (L-ARG) plus Growth Hormone Releasing Hormone (GHRH).

The study will be conducted under an Investigational New Drug (IND) application accepted by the U.S. Food & Drug Administration (FDA) in 10 centres in the USA with 80 subjects.  Half of the subjects will be patients with proven GH deficiency and the other half will be matched controls (healthy subjects). 

GHS is a novel synthetic small molecule sized peptidomimetic agent that is orally active and stimulates the secretion of GH from the patient’s pituitary gland and/or indirectly via stimulation of GHRH from the hypothalamus.

Initial phase I studies have indicated that GHS stimulates growth hormone secretion in a dose dependent manner following oral and intraduodenal administration in healthy male subjects.  No apparent adverse effects of GHS on other hormones (eg ACTH, cortisol, ghrelin, insulin) or on glucose secretion were observed.

GHS is being developed under an exclusive worldwide licence from Æterna Zentaris Inc. (TSX: AEZ, NASDAQ: AEZS) who will receive an undisclosed milestone payment for the initiation of this trial.

As previously announced, the FDA granted Orphan Drug status for GHS in May 2007.

Dr Maureen Lindsay, Ardana’s CEO said “This trial is an important step forward in the development of GHS, which we believe could play a pivotal role in the diagnosis of growth hormone deficiency by providing clinicians with a convenient, reliable and effective diagnostic test.”

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