- IND for Hepatic Artery Injection of Autologous Human Bone Marrow-Derived Mesenchymal Stem Cells (Cellgram) in Patients with Alcoholic Liver Cirrhosis
- Invitrx Therapeutics and Pharmicell Co has finalized an agreement for Pharmicell to transfer Approved IND of Cellgram-LC to Invitrx Therapeutics. The contract also renders Invitrx to be the exclusive Contract Manufacturing Organization (CMO) and is awarded exclusive license for development and commercialization of the product (Cellgram-LC)
- The transition is currently being expedited
- IND for Invitra Extracellular Vesicle Ophthalmic Solution (Invitra EV-OP TM) which is a stem cell-derived extracellular vesicle product for the treatment of Dry Eye Disease (DED)
- pre-IND package submitted and Type B meeting with the FDA was conducted on May 20, 2020 to review and reach agreement on the design of preclinical studies needed to initiate human testing, discuss product formulation, analytical test methods and statistical data requirement, identify and resolve scientific issues, evaluate the safety profile of the drug, ensure adequacy of manufacturing and control standards, and discuss the scope and design of Phase1 testing
- Based on the preliminary meeting, Invitrx is currently working on completing the IND application to meet FDA requirements for complete submission