QSAM Biosciences announced in an Aug. 25, 2021 press release that FDA has cleared QSAM’s Investigational New Drug (IND) application for Samarium-153 DOTMP (CycloSam), allowing the company to commence Phase I clinical trials and the dosing of patients with bone cancer. CycloSam is an investigational radiopharmaceutical for the treatment of bone cancer.
According
to the press release, CycloSam is expected to be an improved formulation of a
previously FDA-approved radiopharmaceutical, Sm-153-EDTMP. CycloSam uses a more
efficient method of isotope manufacturing and an advanced chelation technology.
This may allow for repeated dosing of patients with bone cancer in an effort to
halt or reverse tumor growth.
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Source:
BioPharm