ARDANA’S ORAL GROWTH HORMONE SECRETAGOGUE GAINS ORPHAN DRUG STATUS

Edinburgh, UK, 21 May 2007;  Ardana plc (LSE:ARA) today announces that the US Food and Drug Administration (FDA) has granted Orphan Drug status for ARD-07, its oral Growth Hormone Secretagogue (GHS), which Ardana is developing as a diagnostic for growth hormone deficiency in adults.

The granting of Orphan Drug status in the USA confers a number of advantages such as eligibility to apply for FDA grants towards clinical development, the waiving of the User Registration Fee of $896,200 and other registration fees moving forward.

GHS is a novel synthetic small molecule sized peptidomimetic agent that is orally active and stimulates the secretion of Growth Hormone (GH) from the patient’s pituitary gland and/or indirectly via stimulation of Growth Hormone Releasing Hormone (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 such as ACTH, cortisol, ghrelin, insulin and glucose secretion were observed.

Following meetings with the FDA consensus has been reached that the successful outcome from one pivotal clinical trial will allow registration of GHS as a diagnostic for growth hormone deficiency in adults.

The diagnostic clinical development and toxicology programmes are ongoing and, subject to clinical outcome, the Company anticipates filing for registration at the end of the year with a possible launch in 2008.  Ardana believes that GHS’ oral formulation will give clinicians a simpler and more effective test for growth hormone deficiency.

Dr. Maureen Lindsay, Ardana’s CEO, said:  “We are delighted and very encouraged that the FDA have granted Orphan Drug status for GHS.  We believe that GHS could play a very important role in providing clinicians with a convenient, reliable and effective diagnostic test for growth hormone deficiency.”

In addition to its possible use as a diagnostic, Ardana intends to undertake clinical trials to support registration of GHS in a number of adult therapeutic indications. 

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