Aura Renew Acq Regulatory News (ARA)

7 Sep 2006 07:02

Ardana PLC07 September 2006 ARDANA ANNOUNCES PRELIMINARY POSITIVE PHASE I RESULTS OF TEVERELIX LA FOR THE TREATMENT OF ENDOMETRIOSIS Edinburgh, UK: 7 September 2006: Ardana plc (LSE:ARA), the pharmaceuticalcompany focused on improving human reproductive health, today announcespreliminary results of a Phase I study of the Gonadotrophin Releasing Hormone(GnRH) Antagonist, Teverelix LA (Long Acting) in healthy female subjects. Endometriosis arises in pre-menopausal woman when the lining of the womb(endometrium) grows outside the uterus, often in the pelvic cavity. Symptomsassociated with endometriosis include cyclical or chronic pelvic pain, heavyperiods and infertility. It is well documented that endometriosis is a hormonesensitive condition and a reduction in estrogen levels causes a shrinkage of theendometriotic lesions and an improvement in symptoms. Current treatment optionsinclude GnRH agonists. However this class of compounds is associated with sideeffects, similar to menopausal symptoms, such as hot flushes, reduced libido andloss of bone density, due to the reduction in estrogen to those levels seen inpost-menopausal women. In a previous clinical study of two dose-regimens, different from thoseinvestigated in this study; Teverelix LA has been shown to reduce estrogenlevels rapidly and in a dose-dependent manner. Preliminary data from this Phase I, randomised, single-blind, placebo-controlledstudy of a single subcutaneous injection of Teverelix LA, at one of two doses to24 healthy female subjects, indicates that Teverelix LA can reduce estrogenlevels to a desired level at the lower end of the normal range which should helpto avoid menopausal symptoms. In this study estrogen levels were reduced toaverage concentrations over a period of 8 weeks of 40.5 pg/ml and 49.0 pg/mlrespectively vs. 88.8 pg/ml for placebo. The effect of Teverelix LA on certain bone absorption markers such as serumtelopeptides and urine deoxypyridinoline were also investigated in the study. Onthe basis of the available data these markers appear unaffected by TeverelixLA.. Additional data analysis is ongoing and a complete data set is expected by theend of 2006. This study provides data to support the further development of Teverelix LA inendometriosis and a Phase II study is currently planned to start by the end of2006. Dr Maureen Lindsay, CEO of Ardana said "The results from this study confirm thatTeverelix LA is not only a potential treatment for male indications (prostatecancer and benign prostate hyperplasia) for which we have previously reportedproof-of-concept Phase II results but is also a potential drug for femaleindications that respond to oestrogen suppression, such as endometriosis andeventually fibromyomas of the uterus, both conditions with an unmet medicalneed." It has been estimated that in 2005, there were approximately 17 million cases ofendometriosis in the seven major pharmaceutical markets (US, Japan, France,Germany, Italy, Spain and the UK) of which approximately 3.9 million cases werediagnosed. For more information contact: Ardana Financial DynamicsMaureen Lindsay (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/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 four lead products are summarised below: • 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 hypogonadism; • Teverelix LA, in development for three initial indications (prostate cancer, BPH and endometriosis); • Testosterone Cream, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe. 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. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange