RadioMedix,a clinical stage biotechnology company, and Areva Med, a nuclear biotech company, have announced the initiation in the United States of phase 1 trial for AlphaMedix in patients with somatostatin receptor positive neuroendocrine tumours. AlphaMedix is composed of a somatostatin (SST) analogue radiolabeled with 212Pb, an isotope used for Targeted Alpha-emitter Therapy (TAT).
“Targeted Alpha-emitter Therapy (TAT) is the wave of the future in nuclear oncology and has a tremendous potential to treat patients with NET and overcome some of the limitations of current Peptide Receptor Radionuclide Therapy (PRRT)” said Dr. Ebrahim S. Delpassand, chairman and chief executive officer of RadioMedix, sponsor of the trial.
“Building on compelling preclinical results, I trust that this study with the combination of our excellent research and clinical teams and Areva Med’s expertise in 212Pb-labeled radiotherapeutics development, will mark an important milestone in TAT” added Dr. Izabela Tworowska, CSO of RadioMedix.
This open-label, dose escalation study’s objective is to determine safety, bio-distribution, and preliminary effectiveness of 212Pb-AR-RMX in adult patients with differentiated NETs. Patients will be enrolled at Excel Diagnostic and Nuclear Oncology Center (Houston, TX).
“Excel Diagnostics and Nuclear Oncology Center (EDNOC) was the first institution in the United States to conduct a clinical trial using Lu-177 DOTATATE PRRT, making this therapy available to NET patients. EDNOC in continuation of its tradition, will be the first center to pioneer TAT in the US” added Dr. Delpassand, Medical Director of EDNOC.
“Areva Med has for many years been focused on setting up a reliable production of 212Pb and developing therapeutics using this promising isotope. Our collaboration with RadioMedix and this phase 1 trial is an important accomplishment as we believe that 212Pb-based therapies will have a significant impact on difficult to treat tumours. In this context, AlphaMedix could prove to be particularly appropriate for patients suffering from NETs and go beyond limitations of existing treatments” said Julien Dodet, Areva Med’s chief executive officer.
AlphaMedix is a radiolabeled SSTR-targeting therapeutic investigational drug for treatment of NETs patients. The product consists of SSTR-targeting peptide complex radiolabeled with 212Pb and serve as an in vivo generator of alpha emitting particles. 212Pb isotope is particularly suitable for SSTR therapy applications based upon its half-life, energy and decay properties.