CrystalGenomics "Expecting US Pancreatic Cancer Phase 2 Clinical Trial Approval This Year"

[Asia Economy Reporter Hyungsoo Park] CrystalGenomics announced on the 30th that there were no particularly serious issues in the response to the pre-IND clinical phase 2 inquiry from the US FDA.

Regarding the pancreatic cancer drug candidate Ivaltinostat, which is the most important factor in the US FDA's review for clinical approval, there were no particularly serious issues concerning the drug manufacturing quality control (CMC), pre-clinical data, and clinical data, so the IND filing for clinical approval will be submitted in November.

It was also added that UCSF (University of California San Francisco), one of the leading institutions in the US oncology field, is serving as the clinical responsible institution, and the strategy is being carried out with advice from local experts with global new drug development experience.

A CrystalGenomics official said, "A green light has been turned on for the US clinical trial approval for pancreatic cancer," and added, "We will make this year the first year of the company with a global oncology pipeline without fail."

This content was produced with the assistance of AI translation services.