drugset / Trial / NCT01747980

Safety and Pharmacokinetics of Oral PRX-112 in Gaucher Disease Patients

NCT01747980

Phase 1 Completed 16 enrolled Protalix
NaSingle-groupOpen-labelTreatment

Summary

Absorption of therapeutic proteins taken orally has remained the major hurdle for treatment in humans. The proteins are generally degraded by enzymes in the stomach and intestine and the intestine lining that prevents absorption into the circulation. Administration of PRX-112, a plant recombinant human glucocerebrosidase (prGCD) using plant cells as carrier vehicle, may help overcome many of these hurdles. The plant cell wall protects the protein from degradation in its transport through the upper GI and allows release in the lower intestine. Studies in animals have shown that prGCD delivered in this way can be found in the blood stream in an active form.

Timeline

Start
2013-03
Primary completion
2014-01
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Taliglucerase alfa Protein / enzyme biologic Oral

Indications