QSAM Biosciences Doses First Patient in its Clinical Trial for Radiopharmaceutical Drug Candidate for the Treatment of Bone Cancer

QSAM Biosciences Inc. recently announced the first patient commenced treatment in its clinical trial evaluating CycloSam in patients with metastatic bone cancer.

QSAM previously announced the clearance of its IND by the US FDA and activation of clinical trial sites in its multi-center clinical trial for patients with bone cancer, including cancer that has metastasized from the lung, breast or prostate. Patients with cancer that originated in the bone including osteosarcoma and Ewing’s sarcoma are also eligible to participate. The study is a Phase 1 open-label, dose-escalation trial to evaluate the safety, tolerability, dosimetry, and preliminary efficacy of CycloSam.

“This is an important milestone for QSAM. Successfully treating patients with primary or secondary bone cancer remains an area of significant unmet medical need and a goal for CycloSam. Every day our teams are working toward developing CycloSam as a breakthrough therapeutic for cancer patients, both children and adults, male and female, who unfortunately still have poor options and limited long-term survival prognosis,” said Douglas R. Baum, CEO and co-founder of the company. “We look forward to sharing the results of this study with our shareholders and the medical community.”

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 other FDA-approved radiopharmaceutical products. QSAM is led by an experienced executive team and Board of Directors that completed numerous FDA approvals and multiple successful biotech exits.

CycloSam demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. This radiopharmaceutical technology uses low specific activity Samarium-153 (resulting in far less undesirable europium impurity) and DOTMP, a chelator which the Company believes reduces or eliminates off-target migration, targets sites of high bone turn over, and makes it an ideal agent to treat primary and secondary bone cancers. Because CycloSam delivers targeted radiation selectively to the skeletal system, the company also believes it is an important candidate for use 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 previously approved by the FDA combined with a novel targeting chelant that demonstrated preliminary increased efficacy and decreased side effects in animal models and veterinary treatment of bone cancer in dogs. Further, CycloSam utilizes a well-established, streamlined, just-in-time manufacturing process.