QSAM Biosciences Inc. announced favorable results from a study to evaluate the radioactive impurity levels in its drug candidate Samarium-153-DOTMP (aka CycloSam®). The results of this study are positive indicators about the safety profile and potential expanded uses of CycloSam if ultimately approved for commercial usage by the U.S. Food and Drug Administration (FDA). The study, conducted by leading radiopharmaceutical research firm, IsoTherapeutics Group, LLC, confirmed that the long-lived radionuclidic impurities of Europium-154 (Eu-154) in CycloSam are decreased over 40-fold to nearly non-detectable levels from those reported for a similar adiopharmaceutical product previously approved by the FDA for commercial usage. The findings also indicate significantly less buildup of these impurities, which enhances the clinical utility of CycloSam, potentially allowing safe, multiple dosing regimens, and possibly leading to broader therapeutic applications across multiple indications. QSAM expects to enter Phase 1 clinical trials for CycloSam in the first half of this year. The company, through its exclusive, worldwide license agreement with IsoTherapeutics Group, has issued patents that encompasses Sm-153 and reduced Europium-154 impurity via its ‘High purity therapeutic bone agents’ patents. Technical Information on Eu-154 Impurities: Radionuclidic impurities arise from the production process or the decay of the primary radioisotopes used in radiopharmaceuticals and are of particular concern to clinicians and patients due to the resulting increase in radiation dose received by the patient. Samarium-153 is prepared in a nuclear reactor and, in the process, generates radioactive Eu-154. Eu-154 is present in FDA-approved and clinically utilized products, and there are significant limitations and safety concerns associated with its higher level of impurities because of its long half-life of 8.8 years. Eu-154 administered to a patient can result in the isotope giving an undesirable dose to a patient, essentially irradiating at them at a lower level for years. CycloSam® Sm-153-DOTMP also uses Sm-153 as the isotope, however, due to DOTMP’s superior ability to chelate Sm, it can be formulated with lower specific activity Sm-153. This Sm-153 is irradiated in a beryllium reflector area of the reactor for a shorter period of time, resulting in low or negligible radionuclidic impurities.