Approval Probability
TA Base Rate
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AAV2-GDNF gene therapy · 1 trial · 1 indication
Normalized Good ON time per Hauser Diary
| Arm | Type | Description |
|---|---|---|
| AAV2-GDNF | EXPERIMENTAL | - |
| Control Surgery | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| AAV2-GDNF gene therapy | DRUG | Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose |
| control surgery | PROCEDURE | Bilateral partial burr/twist holes without dural penetration |
Inclusion Criteria: Age 1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics 2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following: 1. Presence of bradykines...
AAV2-GDNF gene therapy is an investigational treatment for moderate Parkinson Disease. It is designed to deliver the GDNF gene to the brain to potentially restore or protect dopamine-producing neurons. The therapy is currently being evaluated in a Phase 2 clinical trial for adults with moderate Parkinson Disease.
AAV2-GDNF gene therapy targets the delivery of the GDNF (glial cell line-derived neurotrophic factor) gene to the brain. This gene encodes a protein that supports the survival and function of dopamine-producing neurons, which are progressively lost in Parkinson Disease. The therapy aims to slow or halt disease progression.
AAV2-GDNF gene therapy is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the OTC market. The company is conducting the REGENERATE-PD trial to evaluate this therapy for Parkinson Disease.
AAV2-GDNF gene therapy is in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial, REGENERATE-PD, is recruiting participants to assess the safety and efficacy of this treatment for moderate Parkinson Disease.
AAV2-GDNF gene therapy is being studied in the REGENERATE-PD trial, identified by the clinical trial number NCT06285643. This Phase 2, randomized, double-blind, sham-controlled study is recruiting 127 adults with moderate Parkinson Disease. The trial is being conducted in the United States, Germany, Poland, and the United Kingdom.
AAV2-GDNF gene therapy is a specific form of GDNF gene therapy. The name 'AAV2-GDNF' indicates that the GDNF gene is delivered using an adeno-associated virus serotype 2 (AAV2) vector. This distinguishes it from other GDNF delivery methods, such as direct protein infusion or different viral vectors.