QSAM’s study is a multiple center, open label, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam® in patients, as well as assess early efficacy signals. Patients with bone cancer that has metastasized from the breast, lungs, prostate or other organs, as well as patients with cancer that has originated in the bone such as osteosarcoma and Ewing’s Sarcoma – diseases that mostly affect children and young adults -- may be eligible.
"We are pleased to be working with the excellent team at
“Metastatic bone cancer is often life threatening and remains an area of high unmet medical need for patients with limited treatment options that are often ineffective,” stated
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 adjacent to areas of bone tumors where the beta-emitting Samarium-153 can irradiate and potentially 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 effectiveness 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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