RNS Number:3659LArdana PLC09 January 2008
ARDANA ANNOUNCES OUTCOME OF PRE-IND MEETING WITH FDA ON TEVERELIX LA FOR THE TREATMENT OF ENDOMETRIOSIS
Edinburgh, UK, January 9, 2008: Ardana Plc (LSE:ARA), the emerging
pharmaceutical company specialising in improving human reproductive health,today announces the positive outcome of a pre-Investigational New Drug (IND)meeting with the United States Food and Drug Administration (FDA) for thedevelopment of its lead compound Teverelix LA (long-acting) for the treatment ofendometriosis.The pre-IND meeting resulted in agreement with the FDA on the clinicaldevelopment path for Teverelix LA in this indication. Ardana plans to open anIND in 2008 and submit the first Phase II study design shortly thereafter.
Endometriosis arises in pre-menopausal women when the lining of the womb(endometrium) grows outside the uterus, typically in the pelvic cavity. Symptoms associated with endometriosis include cyclical or chronic pelvic pain, heavy periods and infertility. It is well documented that endometriosis is a hormone sensitive condition and a reduction in estrogen levels causes a shrinkage of the endometriotic lesions and an improvement in symptoms. Current treatment options include GnRH agonists however this class of compounds is associated with side effects similar to menopausal symptoms including hot flushes, reduced libido and loss of bone density, due to the reduction in estrogen levels to those seen inpost-menopausal women.
In two previous Phase I clinical studies of different dose-regimens,
Teverelix LA has been shown to reduce estrogen levels rapidly and in a dose-dependent manner. Preliminary data from the second Phase I, randomised, single-blind,placebo-controlled study of a single subcutaneous injection of Teverelix LA, atone of two doses to 24 healthy female subjects, indicated that Teverelix LA could reduce estrogen levels to a desired level at the lower end of the normal range which should help to avoid menopausal symptoms. In this study estrogen levels were reduced to average concentrations over a period of 8 weeks of 40.5pg/ml and 49.0 pg/ml respectively vs. 88.8 pg/ml for placebo.
The effect of Teverelix LA on certain bone absorption markers such as serum
telopeptides and urine deoxypyridinoline were also investigated in this study and these markers appeared to be unaffected by Teverelix LA.
Commenting on today's announcement Dr Huw Jones, Ardana's CEO, said: "We are encouraged by the feedback we have received from the FDA on the way forward for Teverelix LA in endometriosis.
There is, in our view, a high unmet medical need for an effective treatment for endometriosis which does not produce menopausal symptoms or a loss of bone mineral density.
"It has been estimated1 that 1 in 10 women suffer from some form of endometriosis during their lives and in 2004 it was estimated that there were approximately 17 million cases of endometriosis in the seven major pharmaceutical markets (US,Japan, France, Germany, Italy, Spain and the UK), of which approximately 3.9million cases were diagnosed.
Teverelix LA is also being developed for the treatment of prostate cancer and BPH (benign prostatic hyperplasia) both of which currently have active INDs.
Ardana announced positive Phase II data in both these indications in the secondhalf of 2007.