QSAM Biosciences Inc. announced that the U.S. Food & Drug Administration (FDA) has cleared the Company's amended clinical trial protocol increasing the maximum age of participants to 75 years old from the prior age limitation of 65. This amendment to the enrollment criteria significantly expands the population of potential participants in QSAM's Phase 1 study evaluating CycloSam(R) in the treatment of bone cancer. older patients comprise a significant percentage of the current population of patients with metastatic bone cancer that is targeted by the CycloSam(R) drug product.

The FDA encourages sponsors to enroll participants who reflect the characteristics of clinically relevant populations, including age and sex, to allow for the collection of sufficient information pertaining to safety and effectiveness for product labeling.