QSAM is actively enrolling patients with metastatic bone cancer in a Phase I clinical trial across four clinical research centers in
“As a radiopharmaceutical development company, it is important to be able to successfully replicate our production process across different nuclear reactors which adds capacity to produce and supply CycloSam® and further diversifies our overall supply chain risk,” stated
“We are pleased to work with
Samarium-153 (Sm-153) is a beta-emitting radioisotope that carries radiation designed and intended to disrupt tumor cell metabolism and cause cancer cell death. With a short 46-hour radiation half-life, Sm-153, in combination with the bone-seeking chelant DOTMP that is believed to significantly limit undesirable off-target migration of radiation to nearby healthy tissues, represents a potentially highly effective bone cancer treatment. The addition of qualified nuclear reactors is expected to support QSAM’s clinical research and future commercial supply of Sm-153 if approved by the FDA.
About
CycloSam® is currently being studied in an open-label, dose escalating Phase 1 safety study at four clinical trial sites in
CycloSam® uses a patented formulation of low specific activity Samarium-153 (resulting in far less long-lived europium impurities) and DOTMP, a chelator that targets sites of high bone turnover and is believed to reduce or eliminate off-target migration, making it, in management’s opinion based on scientific data, an ideal agent to treat primary and secondary bone cancers. Through the carrier vehicle DOTMP, CycloSam® delivers targeted radiation selectively to the skeletal system with high uptake in sites of increased bone turn-over adjacent to bone tumors where the beta-emitting Samarium-153 can irradiate and destroy cancer cells. Because of CycloSam’s mechanism of action and demonstrated safety profile to date, it is also believed to be a candidate for efficacy trials in bone marrow ablation as preconditioning for stem cell transplantation, as well as in procedures to reduce external beam radiation to bone tumors. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process that is already significantly in place. Given these factors, management believes there is a strong pathway to commercialization for CycloSam®.
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