Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AstroRx · 1 trial · 1 indication
Safety and tolerability assessment will be based on treatment emerged adverse events
| Arm | Type | Description |
|---|---|---|
| AstroRx | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AstroRx | BIOLOGICAL | Astrocytes derived from human embryonic stem cells |
Main Inclusion Criteria: 1. El Escorial criteria for probable or definite ALS 2. Males and and non pregnant females between 18 and 70 years of age 3. Patients with an ALS-FRS-R score of at least 30 with an ALS diagnosis of two years or less 4. No history of active psychiatric disorder. Patients rec...
AstroRx is an investigational cell therapy being studied for the treatment of Amyotrophic Lateral Sclerosis (ALS). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The therapy is being evaluated for its safety and potential effects in patients with ALS.
AstroRx is being developed by NewcelX Ltd., a biopharmaceutical company. The company is conducting clinical research to evaluate the therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS). NewcelX Ltd. is the sponsor of the ongoing clinical development program for AstroRx.
AstroRx is currently in Phase 1 clinical development. A Phase 1 clinical trial has been completed to evaluate the therapy in patients with Amyotrophic Lateral Sclerosis (ALS). The therapy remains investigational and has not received regulatory approval for commercial use.
AstroRx has been evaluated in a Phase 1 clinical trial with the identifier NCT03482050. The trial was a study to evaluate transplantation of astrocytes derived from human embryonic stem cells in patients with Amyotrophic Lateral Sclerosis (ALS). The study was conducted in Israel and enrolled 16 participants.
AstroRx is classified as a cell therapy, not a monoclonal antibody. It involves the transplantation of astrocytes derived from human embryonic stem cells. The therapy is being investigated for its potential to treat Amyotrophic Lateral Sclerosis (ALS) by replacing or supporting damaged cells in the nervous system.