The overall market for Radiopharmaceuticals is expected to exceed US$6.1 billion. The rising prevalence of cancer and cardiovascular diseases are the main factors driving the radiopharmaceuticals market.
QSAM Biosciences, Inc. (“QSAM”) is comprised of industry experts formed to acquire the rights to and seek commercialization of Samarium-153 DOTMP, aka CycloSam®, a bone targeting radiopharmaceutical from IsoTherapeutics Group.
IsoTherapeutics’ scientists, leaders in the development of radiopharmaceuticals, also developed FDA approved and commercially released Quadramet® (Samarium-153 EDTMP), indicated for pain palliation.
CycloSam® shares the same FDA approved radioisotope as Quadramet®, but utilizes a novel chelate that had demonstrated preliminary increased efficacy and decreased side effects in animal models.
CycloSam® is cleared by the FDA under an investigator IND to commence human dosing immediately in patients with osteosarcoma and bone metastasis.
The study protocol, Principal Investigator, 1 clinical site and manufacturing plan are all finalized and the clinical trial is ready to commence. Additional sites are proposed to be coming online in the coming months to participate in the clinical trial.
CycloSam® is also cleared by the FDA under a second single-patient IND to perform bone marrow ablation prior to allogenic marrow transplantation (BMA/T).
Fifteen (15) patents under prosecution in the US and internationally; two of which have been issued.