Aura Renew Acq Regulatory News (ARA)

4 Sep 2007 07:01

Ardana PLC04 September 2007 ARDANA ANNOUNCES POSITIVE PRELIMINARY PHASE II RESULTS FOR TEVERELIX LA IN PROSTATE CANCER Edinburgh, UK: 4 September 2007 : Ardana plc (LSE:ARA) today announces positivepreliminary results from a Phase II study in patients with prostate cancerdemonstrating a new dose regimen extended to 8 weeks from 4 weeks for its leaddevelopment compound, the GnRH antagonist, Teverelix Long-Acting (LA). The progression of prostate cancer is driven by male sex hormones (androgens)such as testosterone. It is widely accepted that reducing levels of thesehormones in advanced stage disease can help slow the growth of the cancer andprolong survival. The production of testosterone can be reduced surgically bythe removal of the testes, or through medicines that affect the production oftestosterone. Previous Phase II studies have confirmed that Teverelix LA canattain and maintain suppression of testosterone to castration level for at least4 weeks in patients with prostate cancer. This new study has demonstrated adosage regime that can extend this to at least 8 weeks. Dr. Maureen Lindsay, Ardana's CEO said: "We are very encouraged by thesepositive and very promising preliminary results, which have identified a dose ofTeverelix LA that extends the suppression of serum testosterone to belowcastration level from four weeks to eight weeks or more." Study design This randomised Phase II study involved 38 patients with prostate cancer.Patients were randomly assigned to one of two dose regimens of Teverelix LA. 20patients received the higher dose and 18 patients received the lower dose. Theprimary endpoint was the duration of suppression of testosterone to belowcastration level (< 0.5 ng/ml). The secondary endpoints were the percentage of patients attaining andmaintaining medical castration, the effects on prostate specific antigen (PSA),a commonly used serum marker for prostate cancer, the effects on luteinizinghormone (LH) and the local and systemic tolerability of Teverelix LA. Preliminary study results: Mean testosterone levels in the higher and lower dose groups at baseline were3.71 ng/ml and 4.3 ng/ml respectively. Suppression of testosterone was attainedin both dose groups by Day 3 in 18/20 and 14/18 patients, respectively. Preliminary data from the higher dose group shows that reduction of testosteronelevels to castration level was attained in 19/20 patients. For these 19patients, the duration of castration was between 54 and 147 days with 17patients being castrated for 8 weeks (56 days) or more. Also noted in the higher dose group was a rapid effect on PSA levels. At Week 4,14/19 (74%) of patients had normalised PSA (< 4.0 ng/ml). Mean PSA levels forthe group were normalised at 8 weeks. After skin cancer, prostate cancer is the most common type of cancer diagnosedin men in the USA and is the fourth most common cause of cancer related deathsin men in northern Europe. It is estimated1 that the prostate cancer market wasworth over $4.1 billion in 2005 and is expected to grow to $4.2 billion in 2010. In addition to prostate cancer, Ardana is developing Teverelix LA for two otherindications - benign prostatic hyperplasia (BPH) (Phase II) and endometriosis(Phase I). 1 Wood Mackenzie dataview. 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 built a broad and balanced portfolio to managerisk and actively pursue product and technology in-licensing and out-licensingto 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, for which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • StriantTM 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 development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • Testosterone Cream, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; • InvicorpTM, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. • ARD-07 a growth hormone secretagogue in late stage development for the diagnosis of growth 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. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange