SAINT GENIS POUILLY, France, September 19, 2012 /PRNewswire/ --

Highlights

Advanced Accelerator Applications (AAA), a fast growing international player in Molecular Nuclear Medicine (MNM), announces 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 centres in Europe and North America. The first European patient was enrolled on July 20th 2012 in Madrid, Spain. The FDA approved the trial on September 10th and the first patient is expected to be enrolled in the US during the fourth quarter of 2012.

Stefano Buono, Chief Executive Officer of AAA, commented: "We believe Lutatherarepresents a promising new treatment for patients withthisdisease and other Neuro Endocrine Tumours (NETs). Previous investigator sponsored studies in Europe, Asia and Australia have produced very encouraging data in thousands of patients and as resultLutatherahas been approved, on a named patient basis, for pre-marketing sales in selected European countries."

Study Design

The study, known as NETTER-1, is a Phase III, international, multi-center, randomised, comparator-controlled, parallel-group study evaluating the efficacy and safety of Lutathera compared to Novartis' Sandostatin LAR in patients with inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors. The primary endpoint is the assessment of Progression-Free Survival (PFS). Secondary endpoints include safety, Objective Response Rate (ORR), Time to Tumour Progression (TTP), Overall Survival (OS) and Quality of Life (QoL).

The trial, which is being managed in collaboration with Pierrel Research International, will be conducted at 28 centres across Europe and 14 centres in the USA.

About Lutathera[]

Lutathera, [177]Lutetium-DOTA[0]-Tyr[3]-Octreotate, is a radiolabeled somatostatin analog that selectively targets somatostatin receptors which are over-expressed in some tumor types.

It acts like a Trojan horse, delivering [177]Lu directly into the tumour cell. [177]Lu is an instable particle that releases an electron which, as in radiotherapy, is capable of killing the tumors. It also releases a gamma ray, which exits the body and enables physicians to image and evaluate the progress of the treatment via a SPECT (Single Photon Emission Computed Tomography) camera. Lutathera is a true example of a Theragnostic drug, since its efficacy can be evaluated and monitored using imaging at every therapeutic injection, without additional costs.

Read the original post:

Start of Pivotal Phase III Trial for Lutathera® in Cancer Patients With Progressive Midgut Carcinoid