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Details:
FDA has allowed the Company to proceed with initiation of a Phase II clinical trial of TG-C(TissueGene-C), an allogeneic cell and gene therapy in osteoarthritis (OA) of the hip.
Lead Product(s): TissueGene-C
Therapeutic Area: Musculoskeletal Product Name: TG-C
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 03, 2021
Details:
The trial had been suspended due to product identity concerns. Kolon TissueGene has begun activities to resume the phase III trial and reinitiate enrollment later this year.
Lead Product(s): TissueGene-C
Therapeutic Area: Musculoskeletal Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 13, 2020