Oncoinvent announces completion of enrollment in the RAD-18-002 phase 1 clinical study
Twenty-three colorectal cancer patients in total have been enrolled in the Radspherin® RAD-18-002 phase 1 clinical trial and treated with Radspherin®. No SAE’s related to the Radspherin® treatment have been observed.
Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, today announced that it has successfully completed recruitment of the Radspherin® RAD-18-002 clinical study. 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.
“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”.
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.
Oncoinvent AS is a clinical stage company developing innovative radiopharmaceutical technology that delivers precise, alpha-emitting particles across solid cancers. By leveraging internal manufacturing and supply chain capabilities to enable a clinical supply of radioisotopes, the company is advancing a pipeline of novel products that use alpha particles, a higher Linear Energy Transfer (LET) form of radiation, that can potentially eradicate cancer cells. Oncoinvent’ s lead candidate, Radspherin®, is designed for treatment of metastatic cancers in body cavities, and its versatility allows it to be deployed for the treatment of a variety of cancer indications. Radspherin® is in two ongoing Phase 1 studies to treat peritoneal carcinomatosis from both ovarian cancer and colorectal cancer.
For further information, please contact:
Jan A. Alfheim, Chief Executive Officer
Cell: +47 46 44 00 45
Courtney Turiano, Stern Investor Relations