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FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).
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.
“This IND clearance is another major milestone for QSAM and the advancement of CycloSam. We expect to commence our Phase I open-label dose escalation trial in bone cancer patients by the end of this year. These trials will be intended to investigate the efficacy, safety, tolerability, and pharmacokinectics of CycloSam to establish the optimal dose for pivotal Phase II/III clinical trials,” said Douglas R. Baum, co-founder and CEO, QSAM Biosciences, in a press release. “The clearance of our IND also continues to validate our data-driven approach in oncology drug development and sets the stage for additional aggressive efforts we are undertaking in pediatric and adult cancer therapies.”
According to the press release, CycloSam is expected to be an improved formulation of a previously FDA-approved radiopharmaceutical. 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.
Source: QSAM Biosciences