Palm Beach, FL, Jan. 21, 2021 (GLOBE NEWSWIRE) — QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines for the treatment of cancer and related diseases and conditions, announced today favorable results from a study to evaluate the radioactive impurity levels in its flagship 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 radiopharmaceutical 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.
“We are very pleased with the results of this study as it confirms CycloSam’s superior safety profile for impurities and the integrity of our manufacturing procedures. Developing a radiopharmaceutical for the treatment of multiple types of primary and metastatic bone cancers that safely enables higher and multiple dosing significantly widens the therapeutic applications and utility of our product,” stated Douglas R. Baum, CEO and Co-Founder of QSAM.
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.
About QSAM Biosciences:
QSAM Bioscience, Inc. holds the worldwide license for CycloSam® (Samaium-153 DOTMP), a clinical stage novel radiopharmaceutical meant to treat different types of bone cancer and related diseases. QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc.
CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelant that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.
CycloSam® is cleared by the FDA under an investigator initiated IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020.
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