QSAM Biosciences has commenced subject enrolment for its Phase I clinical trial of its therapy CycloSam (Samarium-153 DOTMP) to treat bone cancer, after activating its first clinical site.
The trial will assess the bone-seeking therapy to treat several types of bone cancer that originated in or has metastasised to the bone.
Developed by IsoTherapeutics Group, CycloSam showed preliminary safety, as well as efficacy in animal studies and a single patient human trial performed last year.
The drug candidate uses DOTMP, a chelant to remove off-target migration.
The multi-centre, dose-escalation Phase I study will determine CycloSam’s maximum tolerated dose in bone cancer patients.
The trial will also evaluate the early efficacy markers.
QSAM Biosciences CEO Douglas Baum said: “The initiation of our first Phase I clinical trial of CycloSam is an important development for QSAM as it demonstrates the potential for treating bone cancers using our new approach.
“We look forward to driving enrolment forward and establishing a safety profile and understanding of CycloSam’s potential for efficacy.”
The company stated that the initial enrolment site for the Phase I clinical trial is at Oncology Consultants in Houston, Texas, US.
Patients suffering from osteosarcoma and Ewing’s Sarcoma are also eligible to enrol in the clinical study.
The US Food and Drug Administration (FDA) granted Orphan Drug Designation to CycloSam for the treatment of osteosarcoma, in August this year.
Approximately 400,000 new malignant bone metastasis cases are diagnosed in the US every year, according to the American Cancer Society.
In January 2021, QSAM Biosciences closed a $2.5m Series B financing round to fund its upcoming clinical trials for its flagship drug ‘Samarium-153-DOTMP’.