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Oncoinvent doses first subject in Phase II ovarian cancer trial

Oncoinvent doses first subject in Phase II ovarian cancer trial

The study is evaluating radspherin for the treatment of peritoneal carcinomatosis due to ovarian cancer. Image credit: NTshutterth/Shutterstock.

Oncoinvent has dosed the first subject in the Phase II clinical trial of Radspherin, an alpha-radiotherapy treatment for peritoneal carcinomatosis due to ovarian cancer.

The randomized, controlled study is intended to assess the effectiveness and safety of the therapy.

The primary objective of the study is to evaluate progression-free survival in patients who receive Radspherin after surgery compared to patients who only undergo preoperative chemotherapy and surgery.

The study will be conducted in six centers in Belgium, Norway, Spain, the United Kingdom and the United States.

The Phase II study follows encouraging results from the Phase I/IIa interim safety analysis.

Radspherin was found to be well tolerated and no dose-limiting toxicity was observed at the recommended dose of 7 MBq.

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Radspherin’s design uses billions of calcium carbonate microparticles to deliver radium-224 directly to cancerous areas in body cavities.

Its mechanism is based on the targeted use of alpha particles, which are known for their strong radiation effects.

The ongoing clinical trials for Radspherin are not only focused on ovarian cancer, but also include investigations into the treatment of peritoneal metastases from colorectal cancer.

The treatment is delivered intraperitoneally after surgical removal of visible tumors and offers a targeted approach to cancer therapy.

Oystein Soug, CEO of Oncoinvent, said: “We are pleased to announce the dosing of the first patient in our Phase 2 trial of Radspherin in ovarian cancer patients. This represents another key achievement that underscores the potential of our clinical program.”

“This milestone builds on the extremely encouraging data from our Phase I/IIa trials in patients with ovarian and colorectal cancer, where Radspherin demonstrated promising safety and efficacy. This follows the recent fast-track approval from the US Food and Drug Administration (FDA), which brings us closer to demonstrating the therapeutic potential of radspherin. We look forward to advancing this clinical trial as part of our mission to improve outcomes for patients with peritoneal carcinomatosis.”

In November 2023, the FDA approved Oncoinvent’s New Drug Application to initiate Phase II clinical trial of Radspherin for the treatment of ovarian cancer-associated peritoneal carcinomatosis.