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Trials |  |
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- | LYS-GM101 / Lysogene
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Gene therapy, Viral vector: A Safety and Efficacy Study of LYS-GM101 Gene Therapy in Patients With GM1 Gangliosidosis (clinicaltrials.gov) - Jun 9, 2023
P1/2, N=5, Terminated, Sponsor: LYSOGENE
N=16 --> 5 | Trial completion date: Jan 2030 --> May 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2026 --> May 2023; The clinical trial is closed due to Lysogene's cessation of activities. This study closure is not due to safety reasons.
- | LYS-GM101 / Lysogene
Preclinical, Journal: AAVrh10 vector corrects pathology in animal models of GM1 gangliosidosis and achieves widespread distribution in the CNS of nonhuman primates. (Pubmed Central) - Nov 3, 2022
Histopathologic examination revealed asymptomatic adverse changes in the sensory pathways of the spinal cord and dorsal root ganglia in both sexes and at both doses. Taken as a whole, these pre-clinical data support the initiation of a clinical study with LYS-GM101 for the treatment of GM1 gangliosidosis.
- | LYS-GM101 / Lysogene
Enrollment closed, Trial completion date, Trial primary completion date, Gene therapy, Viral vector: A Safety and Efficacy Study of LYS-GM101 Gene Therapy in Patients With GM1 Gangliosidosis (clinicaltrials.gov) - Sep 2, 2022
P1/2, N=16, Active, not recruiting, Sponsor: LYSOGENE
Taken as a whole, these pre-clinical data support the initiation of a clinical study with LYS-GM101 for the treatment of GM1 gangliosidosis. Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jan 2030 | Trial primary completion date: Jun 2025 --> Jan 2026
- LYS-GM101 / Lysogene
A Study of Intracisternal Administration of LYS-GM101 in Children with Infantile GM1 Gangliosidosis: Preliminary Results of the Safety Cohort (Poster Board Number: Tu-148; Hall D) - Apr 20, 2022 - Abstract #ASGCT2022ASGCT_1130;
P1/2
The safety cohort data will be reviewed by an independent Data Safety Monitoring Board before initiating the confirmatory phase (Stage 2) with the objective to enroll at least 12 additional patients with early or late infantile GM1 gangliosidosis. Preliminary safety and biomarker data from the first enrolled subjects will be presented during this conference.
- ||| LYS-GM101 / Lysogene
Lysogene Announces a Presentation of its LYS-GM101 Program at the ESGCT 2021 https://t.co/UqdRiwafMs (Twitter) - Oct 18, 2021
- LYS-GM101 / Lysogene
[VIRTUAL] Intracisternal delivery of an AAV gene therapy candidate for the treatment of GM1 Gangliosidosis (Studio 1) - Sep 10, 2021 - Abstract #ESGCT2021ESGCT_106;
P1/2
LYSGM101 is an AAVrh.10 based gene therapy vector carrying the GLB1 cDNA, administered via a onetime injection into the cisterna magna...The trial will enroll 16 patients with a diagnosis of early or late infantile GM1 gangliosidosis at sites in the US and Europe. This talk will focus on nonclinical pharmacology and toxicology studies and elaborate on the current status of the ongoing clinical trial.
- || LYS-GM101 / Lysogene
Enrollment open, Gene therapy, Viral vector: A Safety and Efficacy Study of LYS-GM101 Gene Therapy in Patients With GM1 Gangliosidosis (clinicaltrials.gov) - Apr 25, 2021
P1/2, N=16, Recruiting, Sponsor: LYSOGENE
This talk will focus on nonclinical pharmacology and toxicology studies and elaborate on the current status of the ongoing clinical trial. Not yet recruiting --> Recruiting
- | LYS-GM101 / Lysogene
Trial initiation date, Gene therapy, Viral vector: A Safety and Efficacy Study of LYS-GM101 Gene Therapy in Patients With GM1 Gangliosidosis (clinicaltrials.gov) - Jan 11, 2021
P1/2, N=16, Not yet recruiting, Sponsor: LYSOGENE
Not yet recruiting --> Recruiting Initiation date: Apr 2020 --> Mar 2021
- || LYS-GM101 / Lysogene
New P1/2 trial, Gene therapy, Viral vector: A Safety and Efficacy Study of LYS-GM101 Gene Therapy in Patients With GM1 Gangliosidosis (clinicaltrials.gov) - Feb 17, 2020
P1/2, N=18, Not yet recruiting, Sponsor: LYSOGENE