Palm Beach, FL, Dec. 10, 2020 (GLOBE NEWSWIRE) — QSAM Biosciences Inc. (OTCQB: QSAM), a company developing next generation nuclear medicines, including Cyclosam® Samarium-153-DOTMP, for the treatment of cancer and related diseases and conditions, announced today that the European Patent Office (EPO) has allowed the first patent covering “DOTMP kit formulations for radioisotopes.” This is the first patent outside the United States and is in addition to the two prior patents issued by the United States Patent & Trademark Office (USPTO) covering “High purity and low specific activity therapeutic bone agents.”
The EPO patent allowance covers technology licensed exclusively by QSAM from IGL Pharma, Inc. that protects the radiopharmacy preparation of CycloSam. The DOTMP kits, which refer to the chelating agent that binds the radioisotopes to growing cells in the bone and is believed by management to reduce toxicity and increase efficacy of the drug candidate, are a crucial component of the Cyclosam radiopharmaceutical product.
“We are pleased that the EPO has recognized the novelty of our scientific discoveries and innovations by allowing our first patent outside the United States. This enhances our entire IP estate which currently covers 15 total patents across 3 distinct patent families all of which are in various stages of prosecution and issuance both in the United States and internationally,” stated Douglas R. Baum, CEO of the Company. “We expect additional patents to be issued through our exclusive worldwide license agreement with IGL Pharma, as we add patent filings in the coming year.”
About QSAM Biosciences:
QSAM Bioscience, 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 earlier 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 immediately 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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