'We have met all criteria to continue patient enrollment at a higher dose level in the next group of patients,' stated
QSAM's study is a multiple-center, open label, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam in patients, and also assess early safety and efficacy signals. The total dosage of the active radioisotope Samarium-153 to be received by participants in the second cohort is 50% higher than the total dose received by participants in the first cohort.
Adults with bone cancer that has migrated or metastasized from the breast, lung or prostate is common and frequently fatal. QSAM is dedicated to developing its Cyclosam product for this important patient population, and patients with any of these bone cancer types are eligible for this clinical trial. Osteosarcoma, while still a rare pediatric disease, is the most common form of bone cancer in children and young adults (ages 15-39) with primary high-grade bone malignancy and Ewing's Sarcoma bone cancer is the second most common form of bone cancer in children. According to the Cancer Facts & Figures 2021 produced by the
About
CycloSam has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial performed in 2020 at the
Since CycloSam delivers targeted radiation selectively to the skeletal system and to bone tumors, it is also believed to be a great potential candidate for future effectiveness clinical trials in bone marrow ablation as preconditioning for bone marrow transplantation, as well as its future clinical trials 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 chelant, DOTMP, 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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