QSAM Biosciences Completes Enrollment of Initial Cohort in its Phase 1 Study of CycloSam® Targeting Metastatic Bone Cancer
QSAM Biosciences has completed the enrollment of the first cohort in its Phase 1 clinical trial for CycloSam®, a radiopharmaceutical aimed at treating metastatic bone cancer. The trial assesses the maximum tolerated dose and early safety signals of CycloSam®, with results indicating positive early outcomes. The next cohort, receiving a 50% higher dosage, is set to begin in early Q2 2023. This trial addresses a significant unmet medical need for patients with bone cancer, including those with metastatic breast cancer. The company aims to advance CycloSam® as a treatment option amid limited existing alternatives for female patients.
- Completion of the first cohort in Phase 1 clinical trial for CycloSam®.
- Early positive results regarding safety and efficacy signals.
- Next cohort to receive a 50% higher dosage, commencing in early Q2 2023, indicating progress in the trial.
- None.
Austin, TX, Feb. 28, 2023 (GLOBE NEWSWIRE) -- QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation therapeutic radiopharmaceuticals, including Samarium-153-DOTMP (CycloSam®), for the treatment of bone cancer and related diseases and conditions, today announces the completion of enrollment in the first participant grouping (“cohort”) of its Phase 1 study evaluating CycloSam® in the treatment of bone cancer. The last participant dosed was a breast cancer patient with active metastatic bone cancer.
QSAM’s study is a multiple center, open label, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam® in patients, and also assess early safety and efficacy signals. The completed cohort of three participants received the lowest dosage of CycloSam® in the study. The total dosage of the active radioisotope Samarium-153 to be received by the second cohort, expected to commence in early Q2 2023, will be
“Completion of our first cohort of patients is an important milestone for QSAM,” stated Douglas R. Baum, CEO. “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."
The most recent participant in QSAM’s clinical trial was a patient with breast cancer that had metastasized to the bone, a serious and life-threatening disease for which there is an unmet need by patients and an area of high interest by management for the clinical trials and product development of CycloSam®. The only two commercially available radiotherapies for bone cancer, to management’s knowledge, are only FDA-approved for use in men who have bone metastases from prostate cancer. CycloSam®, which delivers its radioactive payload using a chelant that is highly targeted to high calcium turnover in bone and bone tumors, is currently being studied in a clinical trial for both male and female patients with bone cancer that has metastasized from the breast, lungs, prostate or other organs, as well as patients with cancer that has originated in the bone such as osteosarcoma and Ewing’s Sarcoma – diseases that mostly affect children and young adults.
Adults with bone cancer that has migrated or metastasized from the breast, lung or prostate is common and frequently fatal. QSAM is dedicated to developing its Cyclosam® product for this important patient population, and patients with any of these bone cancer types are eligible for this clinical trial. Osteosarcoma, while still a rare pediatric disease, is the most common form of bone cancer in children and young adults (ages 15-39) with primary high-grade bone malignancy, and Ewing’s Sarcoma bone cancer is the second most common form of bone cancer in children. According to the Cancer Facts & Figures 2021 produced by the American Cancer Society there are about 400,000 new cases of malignant bone metastasis (which includes approximately
About QSAM Biosciences
QSAM Biosciences, Inc. 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 who also developed the FDA-approved Quadramet® (Samarium-153 EDTMP) radiopharmaceutical product. The QSAM team has designed the Cyclosam® product with the goal of overcoming the limitations of the Quadramet® (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 long-lived Europium impurities) and DOTMP, a chelator which 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 and to bone tumors, it is also believed to be a great potential candidate for future effectiveness 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 multi-patented drug candidate utilizes a radioisotope previously approved by the FDA combined with a novel 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®.
Legal Notice Regarding Forward-Looking Statements: This news release contains "forward-looking statements.” These statements relate to future events or our future financial performance. These statements are only predictions and may differ materially from actual future results or events. We disclaim any intention or obligation to revise any forward-looking statements, whether as a result of new information, future developments or otherwise. There are important risk factors that could cause actual results to differ from those contained in forward-looking statements, including, but not limited to, our ability to fully commercialize our technology, risks associated with changes in general economic and business conditions, regulatory risks, clinical trial risks, early stage versus late-stage product safety and efficacy, actions of our competitors, the extent to which we are able to develop new products and markets, the time and expense involved in such development activities, the ability to secure additional financing, the ability to consummate acquisitions and ultimately integrate them, the level of demand and market acceptance of our products, inflation and recession risks, climate-related risks and changes in our business strategies. This is not an offering of securities, and securities may not be offered or sold absent registration or an applicable exemption from the registration requirements.
Corporate Communications
ir@qsambio.com
Namrata Chand, VP-Operations
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