QSAM Biosciences, Inc. announced the addition of Rutgers Cancer Institute of New Jersey (RCINJ) as a clinical trial site approved to begin enrolling patients into the Phase 1 study evaluating CycloSam® in treating patients with bone cancer that either originated in or has metastasized to the bone.
RCINJ is part of Rutgers Health and New Jersey’s only National Cancer Institute (NCI) – designated Comprehensive Cancer Center, an elite recognition that is granted competitively to institutions based on their scientific leadership, resources, and outstanding track record of research discoveries and ability to translate these discoveries to benefit cancer patients. RCINJ is QSAM’s second trial site approved to enroll patients in this study.
QSAM’s study is a multiple-center, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam® in patients, and also assess early efficacy signals. Patients with bone cancer that has metastasized from the breast, prostate, lung, or other organs are eligible to enroll in the study. Additionally, osteosarcoma and Ewing’s Sarcoma bone cancer patients, diseases that mostly affect children and young adults, are also eligible.
"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,” stated Douglas R. Baum, CEO. “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®."
“We look forward to being part of this important clinical trial evaluating this new and novel formulation of Samarium-153 as a therapeutic,” stated Sanjay Goel, MD, Director of Phase I/Investigational Therapeutics and Medical Oncologist who will serve as the Investigator for the clinical trial site located in New Brunswick, NJ. “New treatment options for primary and metastatic bone cancer are very much needed and therapeutic radiopharmaceuticals such as CycloSam® offer potential benefits for these patients,” Dr. Goel added.
Adults with bone cancer that has migrated or metastasized from the prostate, breast, or lung is common and frequently fatal. QSAM is dedicated to developing its Cyclosam® drug candidate for this important patient population to address this major unmet medical need, 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 and 3,610 new cases of primary bone cancer diagnosed in the United States each year.
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