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- | LY3884961 / Eli Lilly
Trial completion date, Trial primary completion date: Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) (clinicaltrials.gov) - Mar 21, 2024
P1/2, N=15, Active, not recruiting, Sponsor: Prevail Therapeutics
Trial completion date: Dec 2028 --> May 2028 | Trial primary completion date: Dec 2028 --> May 2028
- | LY3884961 / Eli Lilly
Enrollment closed, Trial completion date, Trial primary completion date: Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) (clinicaltrials.gov) - Jan 23, 2024
P1/2, N=15, Active, not recruiting, Sponsor: Prevail Therapeutics
Trial completion date: Dec 2028 --> May 2028 | Trial primary completion date: Dec 2028 --> May 2028 Recruiting --> Active, not recruiting | Trial completion date: Sep 2028 --> Dec 2028 | Trial primary completion date: Sep 2028 --> Dec 2028
- | LY3884961 / Eli Lilly
Trial completion date, Trial primary completion date: Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (clinicaltrials.gov) - May 6, 2023
P1/2, N=20, Recruiting, Sponsor: Prevail Therapeutics
Recruiting --> Active, not recruiting | Trial completion date: Sep 2028 --> Dec 2028 | Trial primary completion date: Sep 2028 --> Dec 2028 Trial completion date: Apr 2028 --> Jun 2029 | Trial primary completion date: Apr 2028 --> Jun 2029
- || LY3884961 / Eli Lilly
Enrollment open: Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (clinicaltrials.gov) - Apr 4, 2023
P1/2, N=20, Recruiting, Sponsor: Prevail Therapeutics
Trial completion date: Apr 2028 --> Jun 2029 | Trial primary completion date: Apr 2028 --> Jun 2029 Active, not recruiting --> Recruiting
- || LY3884961 / Eli Lilly
Enrollment open, Trial initiation date: A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED) (clinicaltrials.gov) - Jan 13, 2023
P1/2, N=15, Recruiting, Sponsor: Prevail Therapeutics
Active, not recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Aug 2022 --> Dec 2022
- LY3884961 / Eli Lilly
A baculovirus-produced gene therapy vector LY3884961 (formerly PR001A) demonstrates efficacy in mouse models of Gaucher Disease and tolerability in NHPs () - Sep 25, 2022 - Abstract #ESGCT2022ESGCT_455;
- || LY3884961 / Eli Lilly
New P1/2 trial: A Clinical Trial of PR001 (LY3884961) in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED) (clinicaltrials.gov) - Aug 4, 2022
P1/2, N=15, Not yet recruiting, Sponsor: Prevail Therapeutics
- | LY3884961 / Eli Lilly
Enrollment closed: Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (clinicaltrials.gov) - Jul 5, 2022
P1/2, N=24, Active, not recruiting, Sponsor: Prevail Therapeutics
Not yet recruiting --> Recruiting | Initiation date: Aug 2022 --> Dec 2022 Recruiting --> Active, not recruiting
- PR001 / Eli Lilly
PR001 Gene Therapy Increased GCase Activity and Improved Gaucher Disease Type 1 Phenotypes in Animal Models (Poster Board Number: Tu-36; Hall D) - May 21, 2022 - Abstract #ASGCT2022ASGCT_1992;
Long-term studies evaluating the persistence of PR001, and its therapeutic effects revealed durability out to at least one-year post-administration. Overall, PR001 demonstrated long-lasting efficacy in two independent mouse models of GD supporting further development of PR001 for patients with GD1.
- ||| LY3884961 / Eli Lilly
Enrollment change, Trial completion date, Trial primary completion date: Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (clinicaltrials.gov) - May 4, 2022
P1/2, N=24, Recruiting, Sponsor: Prevail Therapeutics
Overall, PR001 demonstrated long-lasting efficacy in two independent mouse models of GD supporting further development of PR001 for patients with GD1. N=12 --> 24 | Trial completion date: Jun 2027 --> Apr 2028 | Trial primary completion date: Jun 2027 --> Apr 2028
- || PR001 / Eli Lilly
Review, Journal: Gene Therapy for Parkinson's Disease Associated with GBA1 Mutations. (Pubmed Central) - Jan 15, 2022
Studies in mouse models indicate that PR001, a rAAV9 vector-based gene therapy designed to deliver a functional GBA1 gene to the brain, suggest that this therapeutic approach may slow or stop disease progression. PR001 is currently being evaluated in clinical trials with Parkinson's disease patients carrying GBA1 mutations.
- | LY3884961 / Eli Lilly
Trial completion date, Trial primary completion date: Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) (clinicaltrials.gov) - Jun 9, 2021
P1/2, N=15, Recruiting, Sponsor: Prevail Therapeutics
PR001 is currently being evaluated in clinical trials with Parkinson's disease patients carrying GBA1 mutations. Trial completion date: Apr 2028 --> Sep 2028 | Trial primary completion date: Apr 2028 --> Sep 2028
- PR001 / Eli Lilly
[VIRTUAL] PR001 Gene Therapy Increased GCase Activity and Improved Gaucher Disease Type 1 Phenotypes in Animal Models () - Apr 30, 2021 - Abstract #ASGCT2021ASGCT_342;
Long-term studies evaluating the persistence of PR001 and its therapeutic effects are ongoing. Overall, PR001 demonstrated efficacy in two independent mouse models of GD supporting further development of PR001 for patients with GD1.
- |||| PR006 / Prevail Therap, PR001 / Prevail Therap
.@LillyPad firmly steps into #GeneTherapy vs #neurodegenerative diseases, acquiring @PrevailTx for $1B Leads incl PR001 vs #GBA1-mutant #Parkinson’s & neuronopathic #Gaucher; PR006 vs #GRN-mutant #frontotemporal #dementia https://t.co/YiEJVqjf9J #neuroscience #FTD @TenBridge (Twitter) - Dec 15, 2020
- || LY3884961 / Eli Lilly
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) (clinicaltrials.gov) - Sep 30, 2020
P1/2, N=15, Recruiting, Sponsor: Prevail Therapeutics
Overall, PR001 demonstrated efficacy in two independent mouse models of GD supporting further development of PR001 for patients with GD1. Not yet recruiting --> Recruiting | Trial completion date: Dec 2027 --> Apr 2028 | Initiation date: Jun 2020 --> Sep 2020 | Trial primary completion date: Dec 2027 --> Apr 2028
- | LY3884961 / Eli Lilly
Trial completion date, Trial initiation date, Trial primary completion date: Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (clinicaltrials.gov) - Sep 10, 2020
P1/2, N=12, Recruiting, Sponsor: Prevail Therapeutics
Not yet recruiting --> Recruiting | Trial completion date: Dec 2027 --> Apr 2028 | Initiation date: Jun 2020 --> Sep 2020 | Trial primary completion date: Dec 2027 --> Apr 2028 Trial completion date: Aug 2026 --> Jun 2027 | Initiation date: Oct 2019 --> Jan 2020 | Trial primary completion date: Aug 2026 --> Jun 2027
- PR001 / Prevail Therap
[VIRTUAL] PR001 gene therapy improved phenotypes in models of Parkinsons disease with GBA1 mutation () - Aug 2, 2020 - Abstract #AAIC2020AAIC_2045;
These findings demonstrate that PR001 is a promising potential gene therapy for PD-GBA patients. We have recently initiated a Phase 1/2 clinical trial to investigate safety, tolerability, and effects on biomarkers and measures of clinical efficacy.
- || LY3884961 / Eli Lilly
New P1/2 trial: Phase 1/2 Clinical Trial of PR001 in Infants With Type 2 Gaucher Disease (PROVIDE) (clinicaltrials.gov) - Jun 1, 2020
P1/2, N=15, Not yet recruiting, Sponsor: Prevail Therapeutics
- PR001 / Prevail Therap
PR001 Gene Therapy Increased GCase Activity and Ameliorated GBA1-Associated Disease Phenotypes () - May 9, 2020 - Abstract #ASGCT2020ASGCT_75;
Overall, these findings support the clinical development of PR001 for nGD and PD-GBA. We are initiating Phase 1/2 clinical trials to investigate safety, tolerability, biomarkers, and clinical measures of efficacy in nGD and PDGBA patients.
- PR001 / Prevail Therap
Design of Phase 1/2a Study of AAV9-Based Gene Therapy for Parkinson’s Disease with Pathogenic GBA1 Mutations (PROPEL Trial) () - Jan 21, 2020 - Abstract #AAN2020AAN_3255;
P1/2
We are initiating Phase 1/2 clinical trials to investigate safety, tolerability, biomarkers, and clinical measures of efficacy in nGD and PDGBA patients. PROPEL will assess dose, safety, tolerability, biomarker and efficacy effects of PR001 and inform its further clinical development.
- PR001 / Prevail Therap
[VIRTUAL] DESIGN OF THE FIRST-IN-HUMAN TRIAL OF NOVEL AAV9-BASED GENE THERAPY FOR PARKINSON’S DISEASE WITH PATHOGENIC GBA1 MUTATIONS (Hall N) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_267;
The trial will also provide information on the effect of PR001 on biomarker and efficacy endpoints. It is expected that the results of the trial will support further evaluation of PR001 as a potential candidate for the treatment of PD-GBA.
- PR001 / Prevail Therap
[VIRTUAL] PR001 GENE THERAPY IMPROVES PD-GBA PHENOTYPES IN MOUSE MODELS BY INCREASING GCASE ACTIVITY (Hall N) - Jan 6, 2020 - Abstract #AATADPD2020AAT_ADPD_263;
PR001 demonstrated efficacy in two independent mouse models of PD‑GBA and a clean safety profile. We are currently initiating a Phase 1/2 clinical trial to investigate safety, tolerability, biomarkers, and efficacy in PD‑GBA patients.
- | LY3884961 / Eli Lilly
New P1/2 trial: Phase 1/2a Clinical Trial of PR001 (LY3884961) in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL) (clinicaltrials.gov) - Oct 15, 2019
P1/2, N=16, Recruiting, Sponsor: Prevail Therapeutics