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- | AXO-Lenti-PD / Oxford Biomedica
Enrollment change, Trial completion date, Trial termination: SUNRISE-PD: Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease (clinicaltrials.gov) - May 3, 2022
P1/2, N=6, Terminated, Sponsor: Sio Gene Therapies
N=30 --> 6 | Trial completion date: Dec 2031 --> Apr 2022 | Active, not recruiting --> Terminated; As a result of termination of development of OXB-102-01, it is no longer possible for Sio to either commence or to continue any related clinical trials.
- AXO-Lenti-PD / Roivant
[VIRTUAL] Phase 1/2 Open-label Dose Evaluation Study of AXO-Lenti-PD Gene Therapy for Parkinson's Disease: Efficacy, Safety, and Tolerability Data from the Second Cohort at 6 Months () - Sep 29, 2021 - Abstract #MDSCongress2021MDS_Congress_648;
P1/2
Initial data of AXO-Lenti-PD gene therapy at 6M from cohort 2 in the SUNRISE-PD trial demonstrate that ALPD was generally well tolerated and suggest the potential for a clinically relevant effect. Further evaluation of ALPD is planned using a higher dose/volume open label cohort followed by a sham-controlled study.
- AXO-Lenti-PD / Roivant
[VIRTUAL] A GLP Safety and Biodistribution Study of AXO-Lenti-PD Manufactured via Two Processes Delivered at a Higher Volume and Flow Rate () - Apr 30, 2021 - Abstract #ASGCT2021ASGCT_256;
There were no responses against the transgene components in any AXO-Lenti-PD-treated animal. Overall, the results of the study did not identify any LacZ- or AXO-Lenti-PD-related adverse effects associated with a higher volume and flow rate of infusion or any differences in the safety profile of adherent- or suspension-manufactured AXO-Lenti-PD material.
- AXO-Lenti-PD / Roivant
[VIRTUAL] AXO-Lenti-PD Gene Therapy for Parkinson’s Disease: Efficacy, Safety, and Tolerability Data from the Second Cohort in Open-Label Dose Evaluation Study SUNRISE-PD at 6 Months Post Administration () - Apr 30, 2021 - Abstract #ASGCT2021ASGCT_163;
P1/2
The 6M data from the first two cohorts in SUNRISE-PD trial showed that ALPD gene therapy was generally well tolerated, and the initial efficacy data suggest the potential for a clinically relevant effect. Further evaluation of ALPD is planned using a higher dose/volume open label cohort followed by sham-controlled study.
- | AXO-Lenti-PD / Oxford Biomedica
Enrollment closed: SUNRISE-PD: Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease (clinicaltrials.gov) - Jan 29, 2021
P1/2, N=30, Active, not recruiting, Sponsor: Sio Gene Therapies
Further evaluation of ALPD is planned using a higher dose/volume open label cohort followed by sham-controlled study. Recruiting --> Active, not recruiting
- || AXO-Lenti-PD / Roivant
It's actually n=19 (including ProSavin) with increasing responses with increasing dosage $AXGT (Twitter) - Oct 9, 2020
- || AXO-Lenti-PD / Roivant
@bradloncar Axovant raising $750 million. Axo-lenti-pd must be looking good for them and Oxford Biomedica. (Twitter) - Jan 12, 2020
- AXO-Lenti-PD / Roivant
The SUNRISE-PD Study, a clinical trial of AXO-LENTI-PD: a CNS-directed gene therapy for the treatment of Parkinson’s Disease (Agora 3 West, Level 3) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_997;
AXO-Lenti-PD is a lentiviral gene therapy for the treatment of Parkinson’s disease delivering the three genes necessary for endogenous dopamine synthesis directly to the putamen. It is being evaluated in the ongoing SUNRISE-PD study, comprised of a dose-ranging part to determine the optimal dose and a sham-controlled part to assess the efficacy and safety of that dose.
- | AXO-Lenti-PD / Roivant
Preclinical, Journal: Gene Therapy for Parkinson's Disease: Preclinical Evaluation of Optimally Configured TH:CH1 Fusion for Maximal Dopamine Synthesis. (Pubmed Central) - Aug 14, 2019
A toxicology study in macaques demonstrated that the vector was safe and well tolerated, with no associated clinical or behavioral abnormalities and no immune response mounted against any transgene products. Overall, these data support the further clinical development of OXB-102 for the treatment of PD.
- || AXO-Lenti-PD / Roivant, imeglimin (PXL008) / Poxel SA, Roivant, Sumitomo Dainippon
3rd deal w/ EU bios for the -vant galaxy: #1 $POXEL imeglimin in T2D for EU & US (Metavant/Feb'18) #2 $OXB AXO-Lenti-PD/OXB-102 in Parkinsons (Axovant/Jun'18) #3 $MDG1 DC vaccine & TCRs T-Cell for East Asia (Sinovant/Apr'19) (Twitter) - Apr 4, 2019
- | AXO-Lenti-PD / Oxford Biomedica
New P1/2 trial: SUNRISE-PD: Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's Disease (clinicaltrials.gov) - Oct 25, 2018
P1/2, N=30, Recruiting, Sponsor: Oxford BioMedica