Safety review of first dose-level cohort allows progression to second cohort of colorectal cancer patients with peritoneal carcinomatosis in Radspherin® clinical trial.
Oslo 4. September 2020
Oncoinvent AS, a clinical stage radiopharmaceutical company developing novel radioisotope-based therapies announced today that the trial Safety Monitoring Committee overseeing the first-in-human Phase 1 clinical study of Radspherin® in colorectal cancer patients suffering from peritoneal carcinomatosis have approved the advancement of the study to the second level dosing cohort.
Jan A. Alfheim, Chief Executive Officer of Oncoinvent, stated, “Clearance from the trial’s Safety Monitoring Committee to proceed to next dosing cohort is an important milestone in the ongoing clinical trial. Ultimately, our goal with our two ongoing Phase 1 trials is to identify the optimal dose of Radspherin® for treatment of peritoneal carcinomatosis. In addition to determining the safety parameters of the drug, the phase 1 trials will enable us to obtain key biodistribution information and, potentially, initial indication of treatment efficacy. Based on current projections we are on track to complete the dose range finding part of the Phase 1 trial next year and report early patient data from both studies by the end of 2021.”
About the 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.
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. The company is 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.
For further information, please contact:
Jan A. Alfheim, Chief Executive Officer
Cell: +47 46 44 00 45
Tore Kvam, Chief Financial Officer
Cell: +47 95 93 41 99