The first patient was dosed in a clinical trial evaluating the radiopharmaceutical agent, CycloSam, in patients with bone cancer or cancer that has metastasized to the bone.
The first patient was dosed in a clinical trial evaluating CycloSam (Samarium-153-DOTMP) for the treatment of cancer originating in the bone, such as osteosarcoma and Ewing sarcoma, as well as cancer that metastasized (or spread) to the bone from the lung, breast or prostate, according to QSAM Biosciences, the manufacturer of the drug.
The goal of the open-label (meaning that patients and clinicians know what drug is being administered), phase 1 trial is to determine the safety, tolerability and dosimetry (radiation dose) and preliminary efficacy of the drug.
To be eligible for the trial, patients must be aged between 15 and 65 years and have a confirmed diagnosis of a solid tumor that has spread to the bone or osteosarcoma with either an unresectable primary tumor or metastasis. Potential participants should also have proper kidney function and have adequately recovered from the effects of prior chemotherapy. Previous treatments should have been effective, and patients should have no potentially curative options available.
Patients who have received prior radiotherapy to all known areas of their disease or who are not eligible to receive radiotherapy will not be eligible for trial participation.
Of note, the Food and Drug Administration granted a rare pediatric disease designation to CycloSam in February 2022 for the treatment of children with osteosarcoma. In doing so, the radiopharmaceutical agent will be reviewed and potentially brought to the market sooner.
“Successfully treating patients with primary or secondary bone cancer remains an area of significant unmet medical need and a goal for CycloSam,” Douglas R. Baum, CEO and co-founder of QSAM, said in a press release. “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.”
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