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Clinical Trial Report

Gene Therapy Trial Report

Summary

Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease


NCTID NCT03720418 (View at clinicaltrials.gov)
Description
Development Status Inactive
Indication Parkinson Disease
Disease Ontology Term DOID:14330
Compound Name OXB-102
Compound Alias AXO-Lenti-PD, ProSavin
Compound Description EIAV.CMV.TH-CH1.AADC
Sponsor Sio Gene Therapies
Funder Type Industry
Recruitment Status
Terminated
Enrollment Count 6
Results Posted Not Available

Therapy Information


Target Gene/Variant TH-GCH1.DDC (tricistronic)
Therapy Type Gene transfer
Therapy Route In-vivo
Mechanism of Action Overexpression of protective allele/gene
Route of Administration Intraparenchymal (putamen)
Drug Product Type Viral vector
Target Tissue/Cell Striatal neurons
Delivery System Viral transduction
Vector Type EIAV
Editor Type none
Dose 1 1.9E7 TU
Dose 2 4.0E7 TU
Dose 3 1E8 TU
Dose 4
Dose 5

Study Record Dates


Current Stage Phase1, Phase2
Submit Date 2018-10-16
Completion Date 2022-04-12
Last Update 2022-05-03

Participation Criteria


Eligible Age 30 Years - 70 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations


No.of Trial Sites 3
Locations United Kingdom,France

Regulatory Information


Has US IND False
FDA Designations
Recent Updates Axovant rebranded as Sio Gene Therapies, the company dissolved in 2023, returned rights to Oxford Biomedica which has shelved the program

Resources/Links