The US Food and Drug Administration (FDA) has granted clearance for Oncoinvent’s investigational new drug (IND) application to commence the Phase II clinical trial of Radspherin to treat ovarian cancer associated peritoneal carcinomatosis.
Oncoinvent plans to commence the trial in the second quarter of next year.
The controlled, randomised trial will evaluate the safety and efficacy of Radspherin.
Comparison of progression-free survival (PFS) in Radspherin-treated patients following full surgical resection subsequent to pre-operative chemotherapy, as well as those undergoing pre-operative chemotherapy and surgical procedures, will be the primary objective of the trial.
In a Phase I trial of Radspherin in patients with recurrent ovarian cancer, the company chose a recommended 7MBq dose of the therapy.
In addition, interim safety data showed that Radspherin was well tolerated and no dose-limiting toxicity was reported.
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Oncoinvent CEO Anders Månsson said: “We are thrilled to announce the IND clearance for this Phase IIb study of Radspherin, allowing for inclusion of patients in the first-line treatment setting of ovarian cancer.
“This IND clearance comes in succession to the IND clearance of Radspherin in colorectal cancer patients, announced recently.
“With the initiation of two US clinical trials, we look forward to broadening the clinical reach of Radspherin to include both US and Europe.”
Prior to this, the company received IND clearance from the FDA to assess Radspherin for peritoneal carcinomatosis from colorectal cancer.