GARCHING, Germany--(BUSINESS WIRE)--Isotopen Technologien München AG (ITM), a specialized radiopharmaceutical company, today announced the enrollment of the first patient recruited in Europe for the COMPETE phase III clinical trial at the University Hospital Marburg, Germany.
COMPETE is led as an international pivotal multi-center phase III clinical trial evaluating the efficacy and safety of (no-carrier-added) n.c.a.177Lu-Edotreotide (Solucin®) compared to Everolimus. The enrollment requires patients with inoperable, progressive, somatostatin-receptor positive neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The primary endpoint is progression-free survival (PFS). The study will be conducted predominantly in Europe, North America, South Africa and Australia. The first patient to be enrolled and treated was in Australia.
The compound under investigation, Solucin®, is known as a Targeted Radionuclide Therapy (TRT) agent, which consists of the targeting molecule Edotreotide, an octreotide-derived somatostatin analogue and ITM´s EndolucinBeta® (no-carrier-added Lutetium-177). EndolucinBeta® is a synthetic, low-energy beta-emitting isotope of Lutetium, a recently EMA approved pharmaceutical precursor. The radiopharmaceutical Solucin® is administered as an intravenous infusion, specifically targeting and destroying the tumor cells with ionizing radiation.
Solucin® received an Orphan Designation (EMA/OD/196/13) for the treatment of GEP-NET, based on early clinical experience1, which has demonstrated a substantial clinical benefit with increased PFS and quality of life.
Steffen Schuster, Chief Executive Officer of ITM, said: „GEP-NETs are rare diseases with complex clinical features and reduced life expectancy. COMPETE sets a milestone, as there are only few suitable and well tolerated treatment options, where prospective clinical trials with radiopharmaceuticals are limited. We are happy to having enrolled the first patient in Europe for the COMPETE study at the University Hospital Marburg, Germany. This marks the starting point of COMPETE in Europe, whereby we expect a rapid increase in the number of recruits.”
Dr Anja Rinke, coordinator of the NET center at the University Hospital Marburg, added: “COMPETE offers us the opportunity to answer critical questions regarding the treatment of GEP-NETs with Targeted Radionuclide Therapy. In particular, we expect to learn at which point of the treatment algorithm Targeted Radionuclide Therapy should be used most sensibly. Moreover we would like to know whether Targeted Radionuclide Therapy with 177Lu-Edotreotide provides better results than the treatment with a licensed substance, Everolimus.”
For more information about ITM, please visit: http://www.isotope-technologies-munich.com/news/press-releases/
ITM Isotopen Technologien München AG
Chairman of the Supervisory Board - Udo J. Vetter, Executive Board - Steffen Schuster (Chairman), Thomas Dürre
Registered Office of the Company - Lichtenbergstr. 1, 85748 Garching – Commercial Register Munich - HRB 154944