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Also known as Plant cell expressed recombinant glucocerebrosidase (prGCD)
Plant cell expressed recombinant glucocerebrosidase · 1 trial · 1 indication
Calculated as percent change in spleen volume from Baseline to 9 months
| Arm | Type | Description |
|---|---|---|
| prGCD 30 Units/kg | EXPERIMENTAL | - |
| prGCD 60 Units/kg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Plant cell expressed recombinant glucocerebrosidase (prGCD) | DRUG | Intravenous infusion every two weeks for 9 months |
Inclusion Criteria: * Males and females, 18 years or older * Confirmed enzymatic diagnosis of Gaucher disease * Splenomegaly defined as greater than eight times the expected volume (measured volume divided by estimated volume (0.2% of body weight)\] as determined by MRI volumetric analysis * Female...
Plant cell expressed recombinant glucocerebrosidase is being developed for the treatment of Gaucher disease, a rare inherited disorder. It is an investigational therapy studied in adult patients with Gaucher disease. The clinical program has focused on evaluating its safety and efficacy in this rare disease population.
Plant cell expressed recombinant glucocerebrosidase is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the company responsible for advancing this investigational therapy for Gaucher disease through clinical development.
Plant cell expressed recombinant glucocerebrosidase is in Phase 3 clinical development. The Phase 3 trial has been completed. It is an investigational therapy and has not been approved by the FDA for any indication.
Plant cell expressed recombinant glucocerebrosidase has been studied in one Phase 3 clinical trial, NCT00376168, titled A Phase III Trial to Assess the Safety and Efficacy of Plant Cell Expressed GCD in Patients With Gaucher Disease. The trial is completed and enrolled 32 patients across the United States, Canada, Chile, Israel, Italy, South Africa, Spain, and the United Kingdom.
Yes, plant cell expressed recombinant glucocerebrosidase is also known as prGCD. Both names refer to the same investigational therapy being developed by Pfizer for Gaucher disease.