RadioMedix Successfully Completed The Phase I/ II Clinical Studies For Aminomedix Used For Radiation Kidney Protection During Peptide-Receptor Radionuclide Therapy (PRRT)
Houston, TX, Oct. 20, 2016 (GLOBE NEWSWIRE) -- RadioMedix Inc. (Houston,TX) is excited to announce the completion of the Phase I/II clinical trial of
AminoMedix ™ proprietary formulation used for kidney radioprotection during PRRT.
Kidneys are dose-limiting organs during the Peptide Receptor Radionuclide Therapy (PRRT) due to reabsorption of radiotherapeutic agents in the kidneys. Due to the lack of an FDA approved compound to protect kidneys during PRRT, currently different solutions of amino acids are being used, off-labeled, in the clinics. While the co-administration of these megalin-targeting compositions, decrease the accumulation of nephrotoxic radiopeptides in renal proximal tubular cells, it also may lead to severe side effect, including grade 3 or 4 hyperkalemia and severe nausea and vomiting. RadioMedix Phase I/II clinical trials confirmed the correct dose of the components of AminoMedix ™ and also presented both safety and effectiveness of AminoMedix ™ composition in reducing kidney radiation absorbed dose while preventing clinically significant hyperkalemia, nausea and vomiting, during PRRT. RadioMedix has completed the dose optimization of AminoMedix ™ formulation and the company is in the process of scaling up of GMP manufacturing and stability studies of AminoMedix ™ for its centralized distribution plan.
“AminoMedix ™ responds to an unmet need in the growing area of PRRT in patients with Neuroendocrine tumors. The current off label use of TPN and other amino-acid solutions to remedy radiation toxicity related to PRRT in U.S. or other countries in the world is very suboptimal and causes significant adverse effects such as severe nausea, vomiting and hyperkalemia in patients undergoing PRRT. These side effects sometimes have been so severe preventing patients tolerating their treatment. AminoMedixTM proprietory composition (WO 2014/204854 A1) addresses all these adverse effects while protecting the kidneys during PRRT ”, said Dr. Ebrahim S. Delpassand, MD, CEO and Chairman of RadioMedix.
“The AminoMedix composition will limit the nephrotoxic effect of both beta and alpha-emitter labeled agents, including but not limited to positively charged peptides and antibodies. The commercialization of AminoMedixTM aligns well with pipeline of radio-theranostic agents developed by RadioMedix”, echoes Izabela Tworowska, PhD, CSO of RadioMedix.
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://www.radiomedix.com.
Izabela Tworowska , Ph.D., Chief Science Officer RADIOMEDIX, Inc. I 9701 Richmond Ave., Suite 222 I Houston, TX 77042 Mobile: 832-868-2812 I Fax: 713-581-8937 E-mail: itworowska@radiomedix.com