Aura Renew Acq Regulatory News (ARA)

8 Aug 2007 07:00

Ardana PLC08 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 thecommencement in the USA of a planned pivotal registration study of its oralgrowth hormone secretagogue (GHS) ARD-07 which is in development for thediagnosis of growth hormone deficiency in adults. The first patient has nowbeen enrolled in the study. Results from the study are expected in the second half of 2007 and the Companyanticipates filing for registration at the end of the year with a possiblelaunch in 2008. Ardana believes that GHS' oral formulation has the potential togive clinicians a simpler and more effective test for growth hormone deficiency. This phase III study is a multi-centre, randomized, cross-over studyinvestigating the safety and effectiveness of oral GHS as a Growth Hormone (GH)stimulation test compared to intravenous L-Arginine (L-ARG) plus Growth HormoneReleasing Hormone (GHRH). The study will be conducted under an Investigational New Drug (IND) applicationaccepted by the U.S. Food & Drug Administration (FDA) in 10 centres in the USAwith 80 subjects. Half of the subjects will be patients with proven GHdeficiency and the other half will be matched controls (healthy subjects). GHS is a novel synthetic small molecule sized peptidomimetic agent that isorally active and stimulates the secretion of GH from the patient's pituitarygland and/or indirectly via stimulation of GHRH from the hypothalamus. Initial phase I studies have indicated that GHS stimulates growth hormonesecretion in a dose dependent manner following oral and intraduodenaladministration in healthy male subjects. No apparent adverse effects of GHS onother hormones (eg ACTH, cortisol, ghrelin, insulin) or on glucose secretionwere observed. GHS is being developed under an exclusive worldwide licence from AEternaZentaris Inc. (TSX: AEZ, NASDAQ: AEZS) who will receive an undisclosed milestonepayment 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 forwardin the development of GHS, which we believe could play a pivotal role in thediagnosis of growth hormone deficiency by providing clinicians with aconvenient, reliable and effective diagnostic test." For more information contact:Ardana Financial DynamicsMaureen Lindsay Julia PhillipsTel: + 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 andmarketing of innovative products to improve human reproductive health, a $25.5billion market. Since its foundation, Ardana has maintained a broad and balanced portfolio tomanage risk and actively pursues product and technology in-licensing andoutlicensing 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 tickersymbol 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