QSAM Biosciences Announces FDA Clearance of IND for Samarium-153 DOTMP (CycloSam®), an Investigational Radiopharmaceutical for the Treatment of Bone Cancer
Austin, TX, Aug. 25, 2021 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines, including Samarium-153 DOTMP (CycloSam®), for the treatment of cancer and related diseases and conditions, announced that the U.S. Food and Drug Administration (FDA) has cleared QSAM’s investigational new drug (IND) application which allows the Company to commence Phase 1 clinical trials and the dosing of patients with bone cancer.
“This IND clearance is another major milestone for QSAM and the advancement of CycloSam. We expect to commence our Phase 1 open-label dose escalation trial in bone cancer patients by the end of this year. These trials will be intended to investigate the efficacy, safety, tolerability and pharmacokinectics of CycloSam to establish the optimal dose for pivotal Phase 2/3 clinical trials,” stated the Company’s Co-Founder and CEO, Douglas R. Baum. “The clearance of our IND also continues to validate our data-driven approach in oncology drug development and sets the stage for additional aggressive efforts we are undertaking in pediatric and adult cancer therapies.”
CycloSam is expected to be a significantly improved formulation of a previously FDA-approved radiopharmaceutical. This novel drug candidate utilizes both a more efficient method of isotope manufacturing and an advanced chelation technology which may potentially allow for repeated dosing of patients with bone cancer in an effort to halt or reverse tumor growth.
About QSAM Biosciences:
QSAM Biosciences, Inc. is developing next-generation nuclear medicines for the treatment of cancer and related diseases. QSAM’s initial technology is CycloSam® (Samarium-153 DOTMP), a clinical-stage bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space who also developed a previous FDA-approved and commercially available radiopharmaceutical product indicated for pain palliation. QSAM is led by an experienced executive team and Board of Directors that have completed dozens of FDA approvals and multiple successful biotech exits.
CycloSam® has demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared human trial successfully performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium-154 impurity) 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 primary and secondary bone cancers. Since CycloSam® has the ability to deliver targeted radiation selectively 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, and in procedures to reduce external beam radiation to bone tumors. This multi-patented drug candidate utilizes an FDA approved radioisotope combined with a novel chelant that has demonstrated preliminary increased efficacy and decreased side effects in animal models and veterinary treatment of bone cancer in dogs. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process that is already in place. Given these factors, management believes there is a strong pathway to commercialization for CycloSam®.
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Released August 25, 2021