The US Food and Drug Administration (FDA) has granted clearance for Oncoinvent’s investigational new drug (IND) application to commence the Phase IIb clinical trial of Radspherin for peritoneal carcinomatosis in colorectal cancer patients.
The randomised, controlled trial will evaluate the safety and efficacy of Radspherin.
It will enrol patients with peritoneal carcinomatosis from colorectal carcinoma subsequent to cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC).
Progression-free survival (PFS) between patients following CRS and HIPEC and Radspherinc compared to CRS and HIPEC is the trial’s primary objective.
The trial is anticipated to commence in the second quarter of next year.
Oncoinvent CEO Anders Månsson said: “We are excited to announce the IND clearance for Radspherin for colorectal cancer patients following the promising indications of safety and efficacy from the RAD-18-002 Phase I/IIa clinical trial.
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“This is an important corporate milestone for Oncoinvent, allowing us to clinically advance Radspherin and expand to the US landscape. “
“The announcement, in conjunction wisth the positive clinical data supporting Radspherin, continues to reinforce our belief in its transformative potential, and we look forward to advancing its clinical development.”
Findings from the ongoing Phase I/IIa clinical trials of Radspherin showed that all the tested dose levels were found to be well tolerated and 7MBq was determined as the recommended dose.
Furthermore, initial safety and efficacy data from the RAD-18-002 study showed that in patients with peritoneal carcinomatosis from colorectal cancer, none in the 7MBq arm experienced peritoneal recurrences at 18 months.