QSAM Biosciences Inc. (OTCQB: QSAM) is thrilled to announce that the U.S. Food & Drug Administration has cleared the Company’s amended clinical trial protocol, significantly expanding the potential pool of participants for its Phase 1 study evaluating CycloSam® in the treatment of bone cancer. The new age criterion now allows for participants up to 75 years old, as opposed to the 65-years-old limit before. This is an exciting development, opening up the possibility of helping many more patients in the fight against bone cancer.
The prevalence of bone metastases in patients over age 70 is alarmingly high. According to the NIH SEER database, breast cancer patients over 70 have a prevalence of over 30%, and prostate cancer patients have a prevalence of almost 50%. This makes elderly patients a significant portion of those suffering from metastatic bone cancer and in need of CycloSam® drug product. The FDA encourages sponsors to include elderly participants in research studies to ensure that enough information is collected about the safety and effectiveness of the product for labeling.
QSAM’s clinical trial has just seen its first three participants under the care of Julio Peguero, M.D., a board certified Internal Medicine and Medical Oncology Subspecialty physician. Encouragingly, the safety data show no serious adverse events (SAE’s) or clinically significant adverse events that would cause concern for the older population, who are most likely to suffer from bone metastasis. With this promising evidence, QSAM is eager to continue the trial and fill the urgent and immediate need for elderly cancer patients.
QSAM is thrilled to announce that the FDA has cleared their amended clinical trial protocol, which will enable them to accept a larger percentage of participants for enrollment. This will expedite their mission of making CycloSam® available to a wider population of those suffering from a deadly disease. According to CEO Douglas Baum, “Our mission at QSAM is making sure the broadest possible population fighting this deadly disease may one day be able to benefit from CycloSam®.”
About QSAM Biosciences
QSAM Biosciences, Inc., led by an expert team of executives and board members with proven success in the biotech industry, is developing the next generation of nuclear medicines to fight cancer and related diseases. Their first technology, CycloSam® (Samarium-153 DOTMP), is a clinical-stage bone-targeting radiopharmaceutical with the potential to exceed the FDA-approved indications of the current market-leading Quadramet® (Samarium-153 EDTMP) product. By engineering the Cyclosam® product to overcome the limitations of its predecessor, QSAM is pioneering a groundbreaking approach to cancer treatment.
CycloSam® is an innovative nuclear treatment that holds great promise for treating primary and secondary bone cancers. It uses low specific activity Samarium-153, combined with DOTMP, a chelator that is believed to reduce or eliminate off-target migration and target sites of high bone turnover. Unlike other treatments, CycloSam® delivers targeted radiation selectively to the skeletal system and to bone tumors, making it ideal for use in procedures to reduce external beam radiation to bone tumors. The technology is backed by preliminary safety and efficacy data from animal studies and a single patient FDA-cleared human trial performed in 2020 at the Cleveland Clinic. Its streamlined, just-in-time manufacturing process means there is a strong pathway to commercialization. With its potential to revolutionize bone cancer treatment, CycloSam® is a multi-patented drug candidate that holds great hopes for the future.