Austin, Texas, March 17, 2021 (GLOBE NEWSWIRE) — QSAM Biosciences, Inc. (OTCQB: QSAM) announced today that it has signed an Exclusive Option Agreement with IsoTherapeutics Group, LLC to allow the Company a 120-day period to perform diligence and negotiate a worldwide, exclusive license agreement for a pre-clinical staged radiochemical therapy called BetaBrach™.
BetaBrach is a brachytherapy, a cancer treatment where radioactive implants are inserted directly into diseased tissue to eradicate the target tumor. BetaBrach uses beta radiation (Yyttrium-90) chemically formulated to significantly reduce migration to non-targeted healthy tissue. It has been used extensively in numerous small animal laboratory models of cancer as well as in the University of Missouri’s College of Veterinary Medicine to treat large animals with naturally occurring tumors with very promising results. Such therapy could be used to treat many types of cancer in humans, including breast and prostate.
“This is an important step in our strategy to build a pipeline of radiochemical assets to develop and commercialize for critical and high unmet medical needs, such as cancer,” stated Douglas R. Baum, the Company’s CEO and Co-Founder. “Delivering a precise and personalized dose of BetaBrach directly to the targeted tumor has the potential to be an optimal treatment option for a broad base of cancer patients, as we believe it can also prevent the debilitating side effects and systemic toxicity associated with current treatments such as chemotherapy.”
The option to license BetaBrach follows the Company’s strategy used to acquire the worldwide rights to CycloSam® (Samarium-153 DOTMP) in 2020 from an IsoTherapeutics affiliated company whose founders created Quadramet® (Samarium-153-EDTMP), one of the first FDA approved and commercially available radiopharmaceuticals.
About QSAM Biosciences:
QSAM Biosciences, Inc. holds the worldwide license for CycloSam® (Samaium-153 DOTMP), a clinical-stage novel radiopharmaceutical meant to treat different types of bone cancer and related diseases. QSAM’s initial technology is Samarium-153 DOTMP, aka CycloSam®, a clinical-staged bone targeting radiopharmaceutical developed by IsoTherapeutics Group LLC, leaders in the nuclear medicine space who also developed FDA-approved and commercially available Quadramet® (Samarium-153 EDTMP), indicated for pain palliation. CycloSam was assigned to IsoTherapeutics Group’s subsidiary, IGL Pharma, Inc.
CycloSam® has already demonstrated preliminary safety and efficacy in animal studies and a single patient FDA-cleared successful human trial performed in 2020. This nuclear technology uses low specific activity Samarium-153 (resulting in far less europium) and DOTMP, a chelator which is believed to eliminate off-target migration and targets sites of high bone turn over making it an ideal agent to treat osteosarcoma or other bone metastases. Osteosarcoma is the most common malignant bone tumor among children and adolescents. Because of its ability to deliver radiation to the skeletal system, it is also believed to be an effective agent to perform bone marrow ablation as pre-conditioning for bone marrow transplantation. This drug candidate utilizes an FDA approved radioisotope combined with a novel chelant that has demonstrated increased efficacy and decreased side effects in animal models. Further, CycloSam® utilizes a streamlined, just-in-time manufacturing process. Given these factors, management believes there is a strong pathway to commercialization.
CycloSam® is cleared by the FDA under an investigator initiated IND to commence human dosing in patients with osteosarcoma and bone metastasis. CycloSam® was also cleared by FDA and successfully used under a single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T) in 2020.
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