Austin, TX, October 26, 2022 (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 addition of the Rutgers Cancer Institute of New Jersey (RCINJ) as an approved clinical trial site to begin enrolling patients in the Phase 1 study evaluating CycloSam® in the treatment of patients with bone cancer that originated in or has metastasized to the bone.
RCINJ is part of Rutgers Health and the only National Cancer Institute (NCI): Designated Comprehensive Cancer Center, an elite recognition competitively awarded to institutions based on their scientific leadership, resources, and outstanding track record of research discovery and ability to translate these discoveries to the benefit of cancer patients. RCINJ is the second QSAM trial center approved to enroll patients in this study.
The QSAM study is a multi-center, dose-escalation clinical trial to determine the maximum tolerated dose of CycloSam.® in patients, and also evaluate the first signs of efficacy. Patients with bone cancer that has metastasized to the breast, prostate, lung, or other organs are eligible to enroll in the study. In addition, patients with osteosarcoma and Ewing’s sarcoma bone cancer, diseases that primarily affect children and young adults, are also eligible.
“Adding Rutgers as our second clinical trial site will allow us to more quickly advance our study in this major population center in the Northeast,” said Douglas R. Baum, CEO. “We are pleased and honored to have the participation of the outstanding Rutgers CINJ Team, who bring a great depth of knowledge and clinical development experience to our trials for CycloSam.”®.”
“We look forward to being a part of this important clinical trial evaluating this new and novel formulation of Samarium-153 as a therapeutic agent,” said Sanjay Goel, MD, director of Phase I/Investigational Therapeutics and a medical oncologist who will serve as investigator for the clinical trial site located in New Brunswick, NJ. “New treatment options for primary and metastatic bone cancer and therapeutic radiopharmaceuticals such as CycloSam are sorely needed.® offer potential benefits for these patients,” added Dr. Goel.
Adults with bone cancer that has migrated or metastasized from the prostate, breast, or lung is common and often fatal. QSAM is dedicated to developing its Cyclosam® drug candidate for this important patient population to address this significant unmet medical need, and patients with any of these types of bone cancer are eligible for this clinical trial. Osteosarcoma, although still a rare pediatric disease, is the most common form of bone cancer in children and young adults (15 to 39 years) with high-grade primary malignancy of bone, and Ewing’s sarcoma is the second most common. most common form of bone cancer. In children. According to the cancer facts and Figures 2021 Produced by the American Cancer Society, there are about 400,000 new cases of malignant bone metastases and 3,610 new cases of primary bone cancer diagnosed in the United States each year.
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-targeted radiopharmaceutical developed by IsoTherapeutics Group LLC, pioneers in the nuclear medicine space that also developed the FDA-approved Quadramet® (Samarium-153 EDTMP) radiopharmaceutical product, which is indicated to alleviate pain. 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 shown preliminary safety and efficacy in animal studies and a 2020 FDA-approved single-patient human trial at the Cleveland Clinic. This nuclear technology uses low specific activity samarium-153 (resulting in much shorter lived europium impurities) and DOTMP, a chelator that is believed to reduce or eliminate off-target migration and target sites of high bone turnover, which makes it, in management. opinion, an ideal agent to treat primary and secondary bone cancers. From CycloSam® administers selectively targeted radiation to the skeletal system and to bone tumors, it is also believed to be a candidate for efficacy trials in bone marrow ablation as a precondition for bone marrow transplantation, as well as in procedures to reduce external beam radiation to bone tumors. This multi-patent drug candidate uses a previously FDA-approved radioisotope combined with a novel chelator, DOTMP, which has shown preliminary increased efficacy and decreased side effects in animal models and in the veterinary treatment of bone cancer in dogs. In addition, CycloSam® uses a streamlined just-in-time manufacturing process that is already underway. Taking these factors into account, management believes there is a strong path to commercialization of CycloSam.®.
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Namrata Chand, Vice President of Operations