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 and conditions, has completed enrollment in its first participant grouping, or cohort, for its upcoming phase 1 study. The study is designed to evaluate CycloSam in the treatment of bone cancer. The company is focused on developing its Cyclosam product for patients who have bone cancer, which has often migrated or metastasized from the breast, lung or prostate, and is frequently fatal. According to the announcement, the last participant who received a dose was a breast cancer patient with active metastatic bone cancer; the completed cohort was comprised of three participants who all received the lowest dosage. “Completion of our first cohort of patients is an important milestone for QSAM,” said QSAM Biosciences CEO Douglas R. Baum in the press release. “We are pleased with the early results, and are looking forward to continuing enrollment in subsequent cohorts in this important clinical trial evaluating the early safety and efficacy of CycloSam in patients with metastatic bone cancer.”
To view the full press release, visit https://ibn.fm/PNa6W
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. The QSAM team has designed the CycloSam product with the goal of overcoming the limitations of the Quadramet(R) (Samarium-153 EDTMP) product’s FDA-approved indications. 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 is believed to reduce or eliminate off-target migration and targets sites of high bone turnover, 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 great potential candidate for future effectiveness in clinical trials in bone marrow ablation as preconditioning for bone marrow transplantation as well as its future clinical trials 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, 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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