QSAM Biosciences Inc. announced the completion of enrollment in the first participant grouping (“cohort”) of its Phase 1 study evaluating CycloSam in the treatment of bone cancer. The last participant dosed was a breast cancer patient with active metastatic bone cancer. 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 Second Quarter 2023, will be 50% higher. 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 American Cancer Society there are about 400,000 new cases of malignant bone metastasis (which includes approximately 14% of the 265,000 women diagnosed with breast cancer each year), and 3,610 new cases of primary bone cancer diagnosed in the United States each year.