Clinical development of Ardana's Teverelix Long Acting (LA) in prostate cancer continues on track following pre-IND application meeting with the United States Food & Drug Administration (FDA)

Ardana plc (LSE:ARA) today announces that the company has had a pre-Investigational New Drug (IND) application meeting with the FDA to discuss the development for prostate cancer of its lead compound Teverelix LA, a GnRH antagonist.

Recent results from two Phase II studies in patients with prostate cancer have been detailed in previous press releases. In these studies Teverelix LA successfully suppressed serum testosterone to the required levels for treatment.

An additional Phase II study outside the USA is expected to commence within the coming month and results from this study should be available in the first half of 2006.

The FDA has confirmed that serum testosterone levels can serve as a reliable surrogate marker for efficacy in the treatment of prostate cancer.  The meeting reached agreement on the path forward for the development of Teverelix LA for the treatment of prostate cancer, which will allow Ardana to meet its registration timelines and previously announced launch target of the end of 2009.  Ardana is planning to submit to the FDA its first study to be performed under an IND in the pursuit of this indication within the next few months. 

Dr Maureen Lindsay, CEO Ardana, said “We are very encouraged by the feedback we have had from the FDA.  The clinical development and launch for prostate cancer is on track according to our original schedule. Teverelix LA is also being developed for the treatment of Benign Prostatic Hyperplasia (BPH) and Endometriosis. We expect to be reporting shortly on a further meeting with the FDA about BPH. ”

For more information contact:

back to top