On November 8, 2021 Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, reported that it has successfully completed recruitment of the Radspherin RAD-18-002 clinical study (Press release, Oncoinvent, NOV 8, 2021, https://www.oncoinvent.com/press-release/oncoinvent-announces-completion-of-enrollment-in-the-rad-18-002-phase-1-clinical-study/?utm_source=mailpoet&utm_medium=email&utm_campaign=oncoinvent-announces-completion-of-enrollment-in-the-rad-18-002-phase-1-clinical-study_45 [SID1234594736]). All patients enrolled in the study will be followed until disease progression in the abdominal cavity, or for 12 months after the administration of Radspherin whichever comes first. The biodistribution and radiation dosimetry after administration of Radspherin were explored in the six patients included in the expansion phase of the RAD-18-002 study. The dosimetry data will be reported later this year.
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"We are pleased that we did not observe any SAE’s related to the Radspherin, nor did we reach a MTD (maximum tolerated dose) in this phase 1 study." stated Jan A. Alfheim, Oncoinvent CEO. "This indicates that the product is safe to use in combination with cytoreductive surgery and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) in this patient population. We are now busy preparing for the next phase of Radspherin development, in which we will turn our focus on measuring the efficacy of Radspherin in the treatment of peritoneal carcinomatosis".
About Radspherin
Radspherin is a novel alpha-emitting radioactive microsphere suspension designed for treatment of metastatic cancers in body cavities. The radium-224 based therapeutic, Radspherin has shown strong and consistent anticancer activity at doses being essentially non-toxic in preclinical studies. It is anticipated that the product can potentially be used to treat several forms of metastatic cancer.
About the RAD-18-002 Study
The phase 1 open-label, dose-escalation clinical trial is designed to assess the dose, safety, and tolerability of Radspherin, an α-emitting radionuclide therapy, administered into the intraperitoneal cavity in subjects with peritoneal carcinomatosis from colorectal carcinoma following complete cytoreductive surgery and HIPEC. Key objectives in the study include determining maximum tolerated dose, abdominal biodistribution, and preliminary anti-tumor activity. Please refer to www.clinicaltrials.gov for additional clinical trial details.