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Outcome of Pre-IND Meeting
Outcome of Pre-IND Meeting.
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[{"type":"text","content":"\n Ardana PLC\n09 January 2008\n\n\n\n\n ARDANA ANNOUNCES OUTCOME OF PRE-IND MEETING WITH FDA ON TEVERELIX LA \n FOR THE TREATMENT OF ENDOMETRIOSIS\n\n\n\nEdinburgh, UK, January 9, 2008: Ardana Plc (LSE:ARA), the emerging\npharmaceutical company specialising in improving human reproductive health,\ntoday announces the positive outcome of a pre-Investigational New Drug (IND)\nmeeting with the United States Food and Drug Administration (FDA) for the\ndevelopment of its lead compound Teverelix LA (long-acting) for the treatment of\nendometriosis.\n\nThe pre-IND meeting resulted in agreement with the FDA on the clinical\ndevelopment path for Teverelix LA in this indication. Ardana plans to open an\nIND in 2008 and submit the first Phase II study design shortly thereafter.\n\nEndometriosis arises in pre-menopausal women when the lining of the womb\n(endometrium) grows outside the uterus, typically in the pelvic cavity. Symptoms\nassociated with endometriosis include cyclical or chronic pelvic pain, heavy\nperiods and infertility. It is well documented that endometriosis is a hormone\nsensitive condition and a reduction in estrogen levels causes a shrinkage of the\nendometriotic lesions and an improvement in symptoms. Current treatment options\ninclude GnRH agonists however this class of compounds is associated with side\neffects similar to menopausal symptoms including hot flushes, reduced libido and\nloss of bone density, due to the reduction in estrogen levels to those seen in\npost-menopausal women.\n\nIn two previous Phase I clinical studies of different dose-regimens, Teverelix\nLA has been shown to reduce estrogen levels rapidly and in a dose-dependent\nmanner. Preliminary data from the second Phase I, randomised, single-blind,\nplacebo-controlled study of a single subcutaneous injection of Teverelix LA, at\none of two doses to 24 healthy female subjects, indicated that Teverelix LA\ncould reduce estrogen levels to a desired level at the lower end of the normal\nrange which should help to avoid menopausal symptoms. In this study estrogen\nlevels were reduced to average concentrations over a period of 8 weeks of 40.5\npg/ml and 49.0 pg/ml respectively vs. 88.8 pg/ml for placebo.\n\nThe effect of Teverelix LA on certain bone absorption markers such as serum\ntelopeptides and urine deoxypyridinoline were also investigated in this ...