Ardana PLC
08 August 2007
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 AEterna
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.'
For more information contact:
Ardana Financial Dynamics
Maureen Lindsay Julia Phillips
Tel: + 44 (0) 131 226 8550 John Gilbert
Tel: +44 (0)20 7831 3113
About Ardana
Ardana plc is a pharmaceutical company focused on the discovery, development and
marketing of innovative products to improve human reproductive health, a $25.5
billion market.
Since its foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology in-licensing and
outlicensing to maintain a robust pipeline.
Ardana's lead products are summarised below:
• Emselex(R), a once a day treatment for the symptoms of overactive bladder
syndrome which Ardana has exclusive UK marketing and promotion rights and is
being distributed in collaboration with Novartis UK Limited;
• Striant(TM) SR, a testosterone replacement therapy that has been launched by
Ardana through its own sales force in the UK and through marketing partners
in certain European countries, as a treatment for men with confirmed
hypogonadism;
• Teverelix LA, in phase II development for two initial indications
(prostate cancer and benign prostatic hyperplasia) and phase I development
for endometriosis;
• Testosterone Cream, a trans dermal testosterone delivery system in phase
III development for the treatment of male hypogonadism and phase I
development for a female indication;
• Invicorp(TM), an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe.
• ARD-07 an oral growth hormone secretagogue in late stage development for
the diagnosis of hormone deficiency.
In addition, Ardana has a strong portfolio of follow-on products in development.
Ardana is listed on the Main Market of the London Stock Exchange with ticker
symbol ARA-L.
For further information please see www.ardana.co.uk
This information is provided by RNS
The company news service from the London Stock Exchange
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