AAA to conduct pivotal study of Lutate in neuroendocrine tumours
This article was originally published in Clinica
Executive Summary
Advanced Accelerator Applications (AAA) is to begin a pivotal Phase III trial of Lutate, its radiolabelled peptide anticancer compound. The 300-patient multicentre trial will assess Lutate in the treatment of patients with metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs). Saint Genis Pouilly, France-based AAA has commissioned Pierrel Research International to conduct the study. Lutate is a somatostatine analogue labelled with Lutetium-177. It selectively targets somatostatine receptors, which are overexpressed in tumour cells; the radiation then destroys the cells. Lutate has FDA and EMEA Orphan Drug status, giving it protection from competition for seven years in the US and 10 years in Europe following approval. Sales of the compound could begin in 2015 (www.clinica.co.uk, 6 April 2011).