QSAM Biosciences (OTCQB: QSAM), a company developing next-generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP, or CycloSam(R), for the treatment of bone cancer and related diseases, has added Rutgers Cancer Institute of New Jersey (“RCINJ”) as a clinical trial site for its phase 1 CycloSam study. RCINJ has been approved to begin enrolling patients into the study, which will evaluate the effectiveness of CycloSam in treating patients with bone cancer. According to the announcement, RCINJ is part of Rutgers Health and is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center, a designation granted to institutions based on scientific leadership, resources and track record of research discoveries. RCINJ is the second trial site approved to enroll patients in the multiple-center, dose-escalation clinical trial. Eligible patients are those with bone cancer that has metastasized from the breast, prostate, lung or other organs, as well osteosarcoma and Ewing’s Sarcoma bone cancer patients. “The addition of Rutgers as our second clinical trial site will allow us to advance our study more rapidly in this major northeast population center,” said QSAM Biosciences CEO Douglas R. Baum in the press release. “We are pleased and honored to have the participation of the outstanding Rutgers CINJ team, who brings a substantial depth of knowledge and clinical development experience to our trials for CycloSam.”
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About QSAM Biosciences Inc.
QSAM Biosciences is developing next-generation nuclear medicines for the treatment of cancer and related diseases. QSAM’s initial technology, CycloSam (Samarium-153 DOTMP), is a clinical-stage, bone-targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space that also developed the FDA-approved Quadramet(R) (Samarium-153 EDTMP) radiopharmaceutical product, which is indicated for pain palliation. QSAM is led by an experienced executive team and board of directors that have completed numerous 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 performed in 2020 at the Cleveland Clinic. This nuclear technology uses low specific activity Samarium-153 (resulting in far less undesirable europium impurity) and DOTMP, a chelator that targets sites of high mineral turnover (bone) making it, in management’s opinion, an ideal agent to treat primary and secondary bone cancers. Since CycloSam delivers targeted radiation selectively to the skeletal system, it is also believed to be a candidate for effectiveness trials in bone marrow ablation as preconditioning for bone marrow transplantation as well as in procedures to reduce external beam radiation to bone tumors. This multipatented drug candidate utilizes a radioisotope previously approved by the FDA, combined with a novel targeting chelant, DOTMP (“DOTMP”) 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. For more information about the company, please visit www.QSAMBio.com
NOTE TO INVESTORS: The latest news and updates relating to QSAM are available in the company’s newsroom at http://ibn.fm/QSAM
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