Drugs / Glucocerebrosidase
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00258778 | Nov 2005 → Jan 2006 | Gaucher disease | Protalix | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00004293 | Nov 1999 → ? | Gaucher disease | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2014-02-12 | Protalix | Results Protalix BioTherapeutics Announces Oral GCD Data to be Presented at WORLD Symposium 2014 protalix.com ↗
The results demonstrate that Oral GCD was well tolerated across all three doses tested. |
| 2013-10-14 | Protalix | Results Protalix BioTherapeutics Announces Positive Phase I Clinical Trial Results for Oral GCD in Gaucher Disease Patients protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today initial positive results from its phase I clinical trial of oral glucocerebrosidase (GCD), or Oral GCD (PRX-112), in patients with Gaucher disease. |
| 2013-03-07 | Protalix | Regulatory Protalix BioTherapeutics Receives Approval to Initiate Phase I Study in Gaucher Patients With PRX-112, an Orally-Administered Candidate for the Treatment of Gaucher Disease protalix.com ↗ |
| 2011-09-08 | Protalix | Results Protalix BioTherapeutics' Taliglucerase Alfa Phase III Results Published in Blood, the Journal of the American Society of Hematology protalix.com ↗
Additionally, patients treated with taliglucerase alfa in the phase III clinical trial demonstrated an increase in hemoglobin, decrease in liver volume and increase in platelet count. |
| 2009-09-08 | Protalix | Regulatory FDA Grants Protalix Orphan Drug Designation for prGCD protalix.com ↗ |
| 2009-08-25 | Protalix | Regulatory Protalix Receives FDA Fast Track Designation for prGCD protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that it has eceived Fast Track Designation from the U.S. Food and Drug Administration (FDA) for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. |
| 2009-08-17 | Protalix | Regulatory U.S. Food and Drug Administration Approves Protalix’s Treatment Protocol for prGCD protalix.com ↗
Protalix BioTherapeutics, Inc. (NYSE-Amex:PLX), announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's treatment protocol for prGCD, the Company's proprietary plant-cell expressed recombinant form of glucocerebrosidase (GCD) for the treatment of Gaucher disease. |
All press releases naming this drug 14 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glucocerebrosidase | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00258778 ↗ |
| Known as | prGCD | “we evaluate the safety and pharmacokinetics of a novel human recombinant glucocerebrosidase enzyme expressed in transformed plant cells (prGCD), administered to primates and...” PMID 19277123 ↗ Mar 2009 |
| Modality | Protein / enzyme biologic | “glucocerebrosidase enzyme therapy” NCT00004293 ↗ |
| Route | Intravenous | “intravenous glucocerebrosidase” NCT00004293 ↗ |