Edinburgh, Scotland-based Ardana has kicked off a pivotal registration study of its oral growth hormone secretagogue ARD-07 in the USA, after the first patient was enrolled in the trial assessing its use for the diagnosis of growth hormone deficiency in adults.
This Phase III, multicentre, randomised, cross-over study is designed to investigate the safety and effectiveness of oral GHS as a growth hormone stimulation test compared to the current standard intravenous L-arginine plus growth hormone releasing hormone.
Results are expected in the second half of 2007, and Ardana says it anticipates filing ARD-07 for registration at the end of the year, with a possible launch in 2008.
A novel, synthetic small molecule, ARD-07 stimulates the secretion of GH from the pituitary gland and/or indirectly via stimulation of GHRH from the hypothalamus. The company believes that its oral formulation of GHS, which is being developed under an exclusive worldwide licence from Æterna Zentaris, has the potential to give clinicians a simpler and more effective test for growth hormone deficiency.
Meanwhile, in its first interim statement Ardana said it held cash and cash equivalents of £13.3 million for the three month period ending June 30, compared to £16.3 million the prior year, and that net cash used by operating activities inched up 6% to £3.5 million.