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 completed cohort of three participants received the lowest dosage of CycloSam® in the study. The total dosage of the active radioisotope Samarium-153 to be received by the second cohort, expected to commence in early Q2 2023, will be 50% higher.
“Completion of our first cohort of patients is an important milestone for QSAM,” stated
The most recent participant in QSAM’s clinical trial was a patient with breast cancer that had metastasized to the bone, a serious and life-threatening disease for which there is an unmet need by patients and an area of high interest by management for the clinical trials and product development of CycloSam®. The only two commercially available radiotherapies for bone cancer, to management’s knowledge, are only FDA-approved for use in men who have bone metastases from prostate cancer. CycloSam®, which delivers its radioactive payload using a chelant that is highly targeted to high calcium turnover in bone and bone tumors, is currently being studied in a clinical trial for both male and female 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.
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
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Corporate Communications
ir@qsambio.com
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