Oncoinvent Announces Advancement of Radspherin® to Second Dose Level Cohort in Ongoing Phase 1 Trial
Safety Monitoring Committee review of first dose-level cohort allows progression of RAD-18-001 study to second dose level cohort
Oncoinvent AS, a clinical stage radiopharmaceutical company developing novel radioisotope-based therapies, today announced that the trial Safety Monitoring Committee approved the advancement of the study to the second level dose cohort of the company’s first-in-human Phase 1 clinical study of Radspherin®, RAD-18-001, in ovarian cancer patients suffering from peritoneal carcinomatosis. Enrollment in this cohort, where patients will receive 2MBq of Radspherin®, is expected to begin imminently. Radspherin® is also being evaluated in an ongoing Phase 1 study in colorectal cancer patients with peritoneal carcinomatosis.
Jan A. Alfheim, Chief Executive Officer of Oncoinvent, stated, “I am excited that the RAD-18-001 study is now progressing to the second dosing level. Approval from the trial’s Safety Monitoring Committee to proceed to next dosing cohort at 2 MBq is an important milestone in the development of Radspherin®, and we look forward to completing the dose range finding phase of both ongoing phase 1 studies by the second quarter of 2021. We remain on track to report early data from the Radspherin® phase 1 program by the end of 2021.”
RAD-18-001 is an ongoing 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 privately held Norwegian company based in Oslo, Norway committed to developing new innovative products to provide better treatment options to cancer patients. The company’s founders started Oncoinvent in 2010 with a view to designing better cancer treatments by applying known physical and chemical principles of selected novel materials in new ways to maximize their medical benefit while minimizing potential safety concerns. This approach has allowed the company to explore and develop multiple technological avenues before selecting a lead product candidate for preclinical testing.
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Tore Kvam, Chief Financial Officer
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Courtney Turiano, Stern Investor Relations