QSAM - QSAM receives clearance from FDA to expand enrollment criteria for bone cancer treatment
2023-03-08 09:30:07 ET
- QSAM Biosciences ( OTCQB:QSAM ) said on Wednesday the U.S. Food & Drug Administration (FDA) had cleared its clinical trial protocol to increase the maximum age of participants to 75 years old from the prior age limitation of 65, in a phase 1 study testing CycloSam to treat bone cancer.
- The prevalence of bone metastases in patients over age 70 is greater than 30% among breast cancer patients and almost 50% for prostate cancer patients, according to recently published literature from the NIH SEER database
- This is in accordance to the FDA's encouragement for sponsors to enroll participants of clinically relevant populations, including age and sex, to allow for the collection of sufficient information pertaining to safety and effectiveness for product labeling.
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QSAM receives clearance from FDA to expand enrollment criteria for bone cancer treatment