Lutathera first MNM theragnostic drug, enters Ph III in cancer patients with midgut carcinoid

France-based Advanced Accelerator Applications (AAA), a privately-owned player in molecular nuclear medicine (MNM), has announced the initiation of an international Phase III clinical trial evaluating the effect of Lutathera, an investigational peptide, in patients with inoperable progressive midgut carcinoid.

The study will be conducted at multiple centers in Europe and North America. The first European patient was enrolled on July 20 2012 in Madrid, Spain. The US Food and Drug Administration approved the trial on September 10 and the first patient is expected to be enrolled in the US during the fourth quarter of 2012. Lutathera is the first theragnostic drug in Molecular Nuclear Medicine (MNM) to enter phase III clinical development, according to AAA.

Stefano Buono, chief executive of AAA, commented: “We believe Lutathera represents a promising new treatment for patients with this disease and other neuro endocrine tumors (NETs). Previous investigator sponsored studies in Europe, Asia and Australia have produced very encouraging data in thousands of patients and, as result, Lutathera has been approved, on a named patient basis, for pre-marketing sales in selected European countries.”