-- Chimeric has received positive feedback and guidance from the US Food and Drug Administration (FDA) regarding its proposed Phase 1 clinical trial in gastrointestinal and neuroendocrine tumors with CHM 2101
-- Significant milestone in the development pathway for CHM 2101, as the FDA advice supports Chimeric’s planned Phase 1 clinical trial and technical operations strategy
Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), a clinical stage cell therapy company and an Australian leader in cell therapy, is pleased to announce that it has successfully completed a pre-Investigational New Drug (pre-IND) meeting with the US Food and Drug Administration (FDA) and has received positive feedback on the development plan for CHM 2101. This is a significant milestone towards an Investigational New Drug (IND) Application and Phase 1 clinical trial for CHM 2101.
The objective of the meeting was to facilitate FDA regulatory communication and guidance through the IND submission process for CHM 2101. The pre-IND meeting package included details and specific questions regarding the clinical development plan and technical operations, including drug product manufacturing and quality release plan for CHM 2101.
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