FDA granted Orphan Drug Designation to irinotecan-ChemoSeed for malignant glioma
Professor Chris McConville, Chief Scientific Officer of CRISM Therapeutics, commented, “Receiving Orphan Drug Designation from the FDA is a strong validation of the potential of irinotecan-ChemoSeed. From a strategic perspective, this designation enhances the regulatory profile and potential commercial attractiveness of the programme and supports our strategy of advancing differentiated oncology assets that address significant unmet medical needs. When combined with our Innovation Passport and participation in the UK’s ILAP programme, we believe irinotecan-ChemoSeed is well positioned for constructive regulatory engagement as we progress with our registration-grade Phase 2 clinical trial of Irinotecan ChemoSeed in surgically resectable glioblastoma.”
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