RadioMedix and AREVA Med announce initiation of Phase 1 clinical trial of AlphaMedix(TM), a Targeted Alpha Therapy for patients with neuroendocrine tumors

HOUSTON, TX, USA and COURBEVOIE, France I January 10, 2018 I RadioMedix Inc. and AREVA Med today announced the initiation in the United States of Phase 1 trial for AlphaMedixTM in patients with somatostatin receptor positive neuroendocrine tumors. AlphaMedixTM 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 CEO 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 U.S.” 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 tumors. In this context, AlphaMedixTM could prove to be particularly appropriate for patients suffering from NETs and go beyond limitations of existing treatments” said Julien Dodet, AREVA Med’s CEO.

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).

About AlphaMedixTM

AlphaMedixTM 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.

More about RadioMedix

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 radiopharmaceuticals for PET imaging and therapeutic (alpha and beta-labeled) 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 pre-clinical evaluation of radiopharmaceuticals in animal models. More information at www.radiomedix.com.

More about Excel Diagnostics and Nuclear Oncology Center

Excel Diagnostics & Nuclear Oncology Center (EDNOC) is Houston’s leading diagnostic imaging and therapeutic nuclear medicine facility. EDNOC utilizes the latest generation of imaging equipment and offers a full range of imaging modalities. In addition to our comprehensive imaging services, EDNOC pioneers in targeted radionuclide therapy research and offers several targeted therapies for conditions such as lymphoma, neuroendocrine tumors, and prostate cancer. We have assembled a staff of highly skilled technical and medical professionals to meet and exceed the demanding standards of the industry. More information at www.exceldiagnostics.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 recognizing and destroying 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.

SOURCE: RadioMedix

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