Austin, TX, April 28, 2021 (GLOBE NEWSWIRE) — QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next-generation nuclear medicines for the treatment of cancer and related diseases, announced today that it has appointed Richard K. Burt, M.D., to its Scientific Board of Advisors.
“Stem cell procedures, in which Dr. Burt is a world-renowned expert, are a core safety measure to some of the high dose indications we envision for our lead radiopharmaceutical candidate, CycloSam®, due to the way radiation therapy is delivered to the bone. We also see bone marrow ablation prior to a stem cell transplant, similar to the procedure we performed on a patient last year, and potential future uses to treat sickle cell disease, as key indications for our technology,” stated Douglas R. Baum, the Company’s CEO and Co-Founder. “We believe Dr. Burt will bring invaluable clinical guidance to the development of CycloSam, and we are enthusiastic about the contributions he will make to our long-term success.”
Over the last 35 years, Dr. Burt pioneered the use of hematopoietic stem cells to treat autoimmune diseases and he was among the first doctors in the United States and the World to perform autologous hematopoietic stem cell transplants for numerous immune–mediated diseases including rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, Crohn’s disease, type 1 diabetes, and other serious conditions. He was the first Autoimmune Committee Chairperson for the International Bone Marrow Transplant Registry (IBMTR) and was the principal investigator of a National Institute of Health (NIH) $10 million multi-center contract to develop stem cell clinical trials for autoimmune diseases.
In 2006, Dr. Burt was recognized by Scientific American along with Al Gore and Steve Jobs as one of the top 50 people in the world for improving humanity due to his pioneering stem cell work. In 2011, Science Illustrated recognized Dr. Burt’s stem cell work as one of the top 10 advances of the decade.
About QSAM Biosciences:
QSAM Biosciences, Inc. holds the worldwide license for CycloSam® (Samaium-153 DOTMP), a clinical-stage novel radiopharmaceutical meant to treat different types of bone cancer and related diseases. QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc and subsequently exclusively licensed to QSAM Biosciences, Inc.
CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA-approved radioisotope combined with a novel chelant that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.
CycloSam® is cleared by the FDA under an investigator initiated IND to commence human dosing in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020.
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