Oncoinvent Announces U.S. FDA Clearance of Investigational New ...

Oncoinvent AS has received clearance from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for the phase 2b study of Radspherin® in patients with peritoneal carcinomatosis from colorectal cancer. The company is optimistic about the potential of Radspherin® and plans to advance its clinical development. The phase 1/2a clinical trials have shown that Radspherin® is well tolerated, and a recommended dose has been selected. The planned phase 2b trial, set to start in Q2 2024, will compare the efficacy and safety of Radspherin® with standard treatments for colorectal carcinoma.

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Frequently Asked Questions

Q: What is the announcement made by Oncoinvent?

A: Oncoinvent announced the U.S. FDA clearance of their Investigational New Drug (IND) application for Radspherin in colorectal cancer patients.

Q: What is Radspherin?

A: Radspherin is a therapy being developed by Oncoinvent for the treatment of solid cancers.

Q: When was the FDA clearance announcement made?

A: The FDA clearance announcement was made recently, approximately 9 hours ago.

Q: Where can I find more information about Oncoinvent's annual report?

A: You can find more information about Oncoinvent's annual report on their official website. Here is the link to their Annual Report 2022: link

Q: Is there a clinical trial related to Radspherin in colorectal carcinoma subjects?

A: Yes, there is a clinical trial related to Radspherin in colorectal carcinoma subjects. You can find more information about it on the ClinicalTrials.gov website. Here is the link to the study: link