Oncoinvent has dosed the first subject in the Phase II clinical trial of Radspherin, an alpha-radiation therapy, for the treatment of peritoneal carcinomatosis originating from ovarian cancer.
The randomised, controlled trial is designed to assess the therapy’s efficacy and safety.
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Evaluating the progression-free survival in patients who receive Radspherin post-surgery, compared to those who only undergo pre-operative chemotherapy and surgery, is the primary goal of the study.
The trial is being conducted across six centres in Belgium, Norway, Spain, the UK and the US.
The Phase II trial follows encouraging results from the Phase I/IIa safety interim analysis.
Radspherin was found to be well-tolerated with no dose-limiting toxicity seen at the recommended dose of 7MBq.
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By GlobalDataRadspherin’s design leverages billions of calcium carbonate microparticles to deliver radium-224 directly to cancerous areas within body cavities.
Its mechanism relies on the targeted application of alpha particles, known for their potent radiation effects.
The ongoing clinical studies for Radspherin are not only focused on ovarian cancer but also include investigations into treating peritoneal metastases from colorectal cancer.
The treatment is administered intraperitoneally after the surgical removal of visible tumours, offering a targeted approach to cancer therapy.
Oncoinvent CEO Oystein Soug said: “We are pleased to announce the dosing of the first patient in our Phase 2 study of Radspherin in ovarian cancer patients, representing another pivotal achievement that underscores the potential of our clinical programme.
“This milestone builds upon the highly encouraging data from our Phase I/IIa trials in ovarian and colorectal cancer patients, where Radspherin demonstrated promising safety and efficacy. This follows the US Food and Drug Administration (FDA)’s recently granted fast track designation, bringing us closer to demonstrating the therapeutic potential of Radspherin. We look forward to advancing this clinical study as part of our mission to improve outcomes for patients suffering from peritoneal carcinomatosis.”
In November 2023, the FDA gave clearance for Oncoinvent’s investigational new drug application to commence the Phase II clinical trial of Radspherin to treat ovarian cancer-associated peritoneal carcinomatosis.
