Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

NCTID	NCT02132130 (View at clinicaltrials.gov)
Description	The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing. CGF166 is a recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human Atonal transcription factor (Hath1). (Show More)
Development Status	Inactive
Indication	Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Disease Ontology Term	DOID:0070612
Compound Name	CGF166
Compound Description	Ad5-GFAP-ATOH1
Sponsor	Novartis Pharmaceuticals
Funder Type	Industry
Recruitment Status	Completed
Enrollment Count	22
Results Posted	View Results

Target Gene/Variant	ATOH1
Therapy Type	Gene transfer
Therapy Route	In-vivo
Mechanism of Action	Overexpression of protective allele/gene
Route of Administration	Intra-labyrinthine infusion
Drug Product Type	Viral vector
Target Tissue/Cell	GFAP-positive cells
Delivery System	Viral transduction
Vector Type	Ad5
Editor Type	none
Dose 1	Undisclosed dose escalation, 4 levels
Dose 2
Dose 3
Dose 4
Dose 5

No.of Trial Sites	4
Locations	United States

Has US IND	True
FDA Designations
Recent Updates	Study completed, did not show efficacy