QSAM Biosciences Receives Japanese Patent for its Clinical Stage Radiopharmaceutical Drug Candidate, CycloSam®
Austin, TX, April 12, 2022 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam®), for the treatment of cancer and related diseases, announced today that the Japan Patent Office has granted a key patent that protects the use of “lower specific activity” Samarium-153 in conjunction with the treatment of bone cancer in children and adults.
This patent covers within the Japanese market the “high purity therapeutic bone agents” technology exclusively licensed to QSAM on a worldwide basis, and relates to the novel manner in which the Samarium-153 used in CycloSam® is produced. That process reduces long-lived impurities -- namely Europium-154 -- which may allow for higher and multiple dosing regimens in the treatment of different types of bone cancer, including cancer that has metastasized from the lung, breast or prostate. Those types of metastasized bone cancer are the subject of QSAM’s current FDA-cleared Phase 1 clinical trial, which has already begun recruiting and screening patients. Management believes that multi-dosing regimens may be the key to CycloSam® being able to successfully treat bone tumors, and is advancing it clinical trials toward that goal.
“This issuance marks our third granted patent in Japan, and further expands our IP estate consisting of 14 patents among 3 distinct patent families. This additional IP protection broadens our potential commercial market internationally for what we believe may be a breakthrough therapy for both primary and secondary forms of bone cancer,” stated Douglas R. Baum, CEO and co-founder of the Company.
About QSAM Biosciences
QSAM Biosciences, Inc. is developing next-generation nuclear medicines for the treatment of cancer and related diseases. QSAM’s initial technology, CycloSam® (Samarium-153 DOTMP), is a clinical-stage bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space who also developed the FDA-approved Quadramet® (Samarium-153 EDTMP) radiopharmaceutical product, which is indicated for pain palliation. QSAM is led by an experienced executive team and Board of Directors that have completed numerous FDA approvals and multiple successful biotech exits.
CycloSam® has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium impurity) and DOTMP, a chelator which is believed to reduce or eliminate off-target migration and targets sites of high bone turn over making it, in management’s opinion, an ideal agent to treat primary and secondary bone cancers. Since CycloSam® delivers targeted radiation selectively to the skeletal system, it is also believed to be a great candidate for effectiveness trials in bone marrow ablation as pre-conditioning for bone marrow transplantation, and in procedures to reduce external beam radiation to bone tumors. This multi-patented drug candidate utilizes a radioisotope approved by the FDA previously combined with a novel chelant that has demonstrated preliminary increased efficacy and decreased side effects in animal models and veterinary treatment of bone cancer in dogs. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process that is already in place. Given these factors, management believes there is a strong pathway to commercialization for CycloSam®.
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Released April 12, 2022