QSAM Biosciences announces 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 in the treatment of bone cancer. Douglas Baum, CEO of QSAM stated: "We thank the FDA for clearing our amended clinical trial protocol, which should allow us to accept a greater percentage of the participants screened for enrollment, and as a result, move the study ahead more quickly and efficiently. Our mission at QSAM is making sure the broadest possible population fighting this deadly disease may one day be able to benefit from CycloSam."
Published first on TheFly
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