Houston, TX; Plano, TX, (June 21st, 2017) – 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 pre-clinical 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.
About Neuroendocrine Tumors
Neuroendocrine tumors (NETs) are a heterogeneous group of rare neoplasms that originate from neuroendocrine cells. These neoplasms occur mostly in the gastrointestinal tract and pancreas, but can also occur in other tissues including thymus, lung, and other uncommon sites such as ovaries, heart and prostate. Most NETs strongly express somatostatin receptors (SSTRs), predominantly of the SSTR2 subtype, providing the basis of anti-secretory and antiproliferative therapy with somatostatin agonists (SSA), such as octreotide or lanreotide. Peptide receptor radiotherapy (PRRT), using therapeutically radiolabeled SSTR receptor ligands, directed against SSTRs has shown highly promising outcomes, even in patients with advanced disease.
More about RadioMedix Inc.
RadioMedix, Inc. is a clinical stage biotechnology company, based in Houston, Texas, focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring and therapy of cancer. The company is commercializing generator-produced radiopharmaceuticals based on Gallium-68 chemistry for PET imaging and therapeutic (Alpha and Beta) radiopharmaceuticals for targeted radionuclide therapy in cancer. RadioMedix has also established two service facilities for academic and industrial partners: cGMP Manufacturing Suite for human clinical trials and probe development and small animal Molecular Imaging Facility for evaluation of agents in animal models. More information at http://radiomedix.com.
More about AREVA Med
AREVA Med is a nuclear biotech company developing innovative therapies in oncology. AREVA Med has developed new processes for producing lead-212 (212Pb), a rare radioactive isotope used in Targeted Alpha Therapy (TAT), an innovative and promising approach of nuclear medicine allowing to recognize and destroy cancer cells while limiting the impact on nearby healthy cells. With its partners, AREVA Med pursues the development of effective therapies to address patients’ needs. AREVA Med is the subsidiary of the AREVA group. More information at http://arevamed.com. Follow @AREVAmed on Twitter.
Media Contact : Izabela Tworowska, PhD