Oncoinvent Announces Advancement of Radspherin® to Fourth Dose Level Cohort in Ongoing RAD-18-001 Phase 1 Trial in Ovarian Cancer Patients
Safety Monitoring Committee review of third dose-level cohort allows progression of Phase 1 RAD-18-001 study to fourth and final cohort dose level cohort
Oncoinvent AS, a clinical stage company advancing a pipeline of radiopharmaceutical products across a variety of solid cancers, today announced that the trial Safety Monitoring Committee approved its first-in-human Phase 1 clinical study of Radspherin® in ovarian cancer patients suffering from peritoneal carcinomatosis to progress to the fourth level dose cohort. Enrollment in this cohort, where patients will receive 7 MBq of Radspherin®, is expected to begin imminently.
“The progression of the RAD-18-001 study to the fourth dose level, continues to build our confidence as we continue to develop Radspherin® for treatment peritoneal carcinomatosis, an area of high unmet need,” said Jan A. Alfheim, Chief Executive Officer of Oncoinvent. “we will now start dosing patients at the 7 MBq dose level, a dose level that has been found to be safe in colorectal cancer patients.”
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 ovarian cancer following complete cytoreductive surgery. 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.
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.
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 versality 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, CEO
Cell: +47 46 44 00 45
Courtney Turiano, Stern Investor Relations