Oncoinvent AS, a company in the clinical stage focused on advancing alpha emitter therapy for various solid cancers, has officially received approval from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application related to the phase 2 study for Radspherin® in patients suffering from peritoneal carcinomatosis due to ovarian cancer. This marks the second IND clearance for Radspherin® by the U.S. FDA, as the company also recently disclosed the acceptance of an IND for Radspherin® in patients with peritoneal carcinomatosis caused by colorectal cancer.

Oncoinvent, expressed great excitement regarding the IND clearance for this phase 2b study of Radspherin®, which allows for the inclusion of patients in the first-line treatment of ovarian cancer. This accomplishment closely follows the IND clearance for Radspherin® in colorectal cancer patients. With the launch of two clinical trials in the United States, Oncoinvent looks forward to expanding the clinical application of Radspherin® to include both the United States and Europe. With compelling data supporting Radspherin® from both clinical programs, the company remains unwavering in its mission and eagerly anticipates advancing to the next stages of development.

In the phase 1 clinical trial of Radspherin® involving patients with recurrent ovarian cancer, a recommended dose of 7MBq was chosen following the completion of dose escalation. Oncoinvent recently presented preliminary safety data from the ongoing RAD-18-001 study evaluating the dose, safety, and tolerability of Radspherin® in patients with recurrent ovarian cancer at the 24th Congress of the European Society of Gynaecological Oncology (ESGO). The interim safety analysis of the trial revealed that Radspherin® was well-tolerated, with no instances of dose-limiting toxicity.

The trial for which U.S. FDA clearance has been granted is set to commence in the second quarter of 2024. It is a randomized controlled phase 2b trial designed to evaluate the efficacy and safety of Radspherin® in patients with peritoneal metastasis originating from ovarian cancer. The primary objective is to compare progression-free survival (PFS) between patients who receive Radspherin® after complete surgical resection following pre-operative chemotherapy and patients who undergo only pre-operative chemotherapy and surgery.

 

Source: businesswire.com

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