RadioMedix Inc. and AREVA Med announced today the completion of the exploratory clinical trial evaluating the biodistribution and safety of 203Pb-AR-RMX in patients with somatostatin receptor positive neuroendocrine tumors in May of 2017.
A total of six patients were enrolled in the first-in-human open-label, single-dose, dosimetry and biodistribution of 203Pb-AR-RMX. All patients were evaluated and followed up for any evidence of renal, hepatic, or hematologic toxicity. No significant acute toxicity was observed during or after the scans. As no statistically significant difference was observed between the 68Ga-DOTATATE PET/CT and 203Pb-AR-RMX SPECT/CT, 68Ga-DOTATATE could be used in lieu of 203Pb-SPECT/CT to evaluate the eligibility of patients for further targeted alpha therapy with 212Pb-AR-RMX (AlphaMedixTM).
“We are pleased to announce the completion and favorable results of the eIND”, said Dr.Ebrahim Delpassand, CEO of RadioMedix Inc. “We strongly believe that 212Pb-Targeted Alpha Therapy using AlphaMedixTM has the potential to expand the therapeutic treatment options available to patients with neuroendocrine cancers,” added Dr. Delpassand.
“The results of the preclinical efficacy and toxicity studies of 212Pb-AR-RMX (AlphaMedixTM), as well as the favorable outcome of current eIND study of this agent, provide us guidance on the design of the first-in-human clinical studies of alpha-emitter-labeled AR-RMX,” said Dr. Izabela Tworowska, CSO of RadioMedix Inc. “Both RadioMedix and AREVA Med are fully committed to initiate the Phase 1 clinical studies of AlphaMedixTM for targeted alpha emitter therapy of neuroendocrine tumors as soon as possible,” added Dr. Tworowska.
“With the completion of the exploratory 203Pb-AR-RMX clinical trial, we reached an important milestone in our efforts to bring new 212Pb-labeled compounds into clinical development. We are eager to start the Phase 1 clinical studies of 212Pb-AR-RMX (AlphaMedixTM) that could be a new option for patients affected by neuroendocrine tumors,” said Dr. Julien Torgue, AREVA Med’s Scientific Director.