Skip to main content
Loading...

ProCellEx® Platform

Plant specific N-glycans do not have proven adverse effects in humans.

Shaaltiel Y, Tekoah Y.
Nat Biotechnol. 2016 Jul(pp,.1-3)

read more
Large-scale production of pharmaceutical proteins in plant cell culture-the Protalix experience.

Tekoah Y, Shulman A, Kizhner T, Ruderfer I, Fux L, Nataf Y, Bartfeld D, Ariel T, Gingis-Velitski S, Hanania U, Shaaltiel Y.
Plant Biotechnol J. 2015(pp.1-10)

read more
Establishment of a tobacco BY2 cell line devoid of plant-specific xylose and fucose as a platform for the production of biotherapeutic proteins.

Hanania U, Ariel T, Tekoah Y, Fux L, Sheva M, Gubbay Y, Weiss M, Oz D, Azulay Y, Turbovski A, Forster Y, Shaaltiel Y.
Plant Biotechnol J. 2017(pp.1-10)

read more
Preclinical and first-in-human evaluation of PRX-105, a PEGylated, plant-derived, recombinant human acetylcholinesterase-R.

Atsmon J, Brill-Almon E, Nadri-Shay C, Chertkoff R, Alon S, Shaikevich D, Volokhov I, Haim KY, Bartfeld D, Shulman A, Ruderfer I, Ben-Moshe T, Shilovitzky O, Soreq H, Shaaltiel Y.
Toxicol Appl Pharmacol. 2015(pp.1-10)

read more
Plant-based oral delivery of β-glucocerebrosidase as an enzyme replacement therapy for Gaucher’s disease.

Shaaltiel Y, Gingis-Velitski S, Tzaban S, Fiks N, Tekoah Y,
Aviezer D.
Plant Biotechnol J. 2015(pp.1-8)

read more

Pegunigalsidase alfa

Development and Analytical Characterization of Pegunigalsidase Alfa, a Chemically Cross-Linked Plant Recombinant Human α‑Galactosidase‑A for Treatment of Fabry Disease.

Ruderfer R., Shulman A., Kizhner T., AzulayY., Nataf Y., Tekoah Y., and  Shaaltiel Y.
Bioconjug Chem. 2018. May 16;29(5):1630-1639.

read more
Pegunigalsidase alfa, a novel PEGylated enzyme replacement therapy for Fabry disease, provides sustained plasma concentrations and favorable pharmacodynamics: A 1-year Phase 1/2 clinical trial.

Schiffmann R, Goker-Alpan O, Holida M, Giraldo P, Barisoni L, Colvin RB, Jennette CJ, Maegawa G, Boyadjiev SA, Gonzalez D, Nicholls K, Tuffaha A, Atta MG, Rup B, Charney MR, Paz A, Szlaifer M, Alon S, Brill-Almon E, Chertkoff R, Hughes D.
J Inherit Metab Dis. 2019. May;42(3):534-544.

read more
Head-to-head trial of pegunigalsidase alfa versus agalsidase beta in patients with Fabry disease and deteriorating renal function: results from the 2-year randomised phase III BALANCE study.

Wallace EL, Goker-Alpan O, Wilcox WR, Holida M, Bernat J, Longo N, Linhart A, Hughes DA, Hopkin RJ, Tøndel C,
Langeveld M, Giraldo P, Pisani A, Germain DP, Mehta A,
Deegan PB, Molnar MJ, Ortiz D, Jovanovic A, Muriello M, Barshop BA, Kimonis V, Vujkovac B, Nowak A, Geberhiwot T, Kantola I, Knoll J, Waldek S, Nedd K, Karaa A, Brill-Almon E,
Alon S, Chertkoff R, Rocco R, Sakov A, Warnock DG. 
J Med Genet. 2023. Nov 8:jmg-2023-109445.

read more
Safety and efficacy of pegunigalsidase alfa in patients with Fabry disease who were previously treated with agalsidase alfa: results from BRIDGE, a phase 3 open-label study.

Linhart A, Dostálová G, Nicholls K, West ML, Tøndel C,
Jovanovic A, Giraldo P, Vujkovac B, Geberhiwot T, Brill-Almon E, Alon S, Chertkoff R, Rocco R, Hughes D.
Orphanet J Rare Dis. 2023. Oct 21;18(1):332.

read more

Presentations of pegunigalsidase alfa at International Conferences

First results of a head-to-head trial of pegunigalsidase alfa vs. agalsidase beta in Fabry disease: 2-year results of the phase 3 randomized, double-blind, BALANCE study.

Oral presentation by Eric Wallace, M.D.
WORLDSymposium: 19th Annual Research Meeting | Orlando, FL, US | February 22–26, 2023

read more
First results of a head-to-head trial of pegunigalsidase alfa vs. agalsidase beta in Fabry disease: 2-year results of the phase 3 randomized, double-blind, BALANCE study.

Poster presentation by Eric Wallace, M.D.
WORLDSymposium: 19th Annual Research Meeting | Orlando, FL, US | February 22–26, 2023

read more

The Taliglucerase alfa Story

Taliglucerase alfa: An enzyme replacement therapy using plant cell expression technology.

Grabowski GA, Golembo M, Shaaltiel Y.
Mol Genet Metab 2014;112:1–8.

read more
Large-scale production of pharmaceutical proteins in plant cell culture-the Protalix experience.

Tekoah Y, Shulman A, Kizhner T, Ruderfer I, Fux L, Nataf Y, Bartfeld D, Ariel T, Gingis-Velitski S, Hanania U, Shaaltiel Y.
Plant Biotechnol J. 2015 Oct;13(8):1199-208.

read more
Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems-The taliglucerase alfa story.

Rup B, Alon S, Amit-Cohen BC, Brill Almon E, Chertkoff R, Tekoah Y, Rudd PM.
PLoS One. 2017 Oct 31;12(10):e0186211.

read more
Establishment of a tobacco BY2 cell line devoid of plant-specific xylose and fucose as a platform for the production of biotherapeutic proteins.

Hanania U, Ariel T, Tekoah Y, Fux L, Sheva M, Gubbay Y,
Weiss M, Oz D, Azulay Y, Turbovski A, Forster Y, Shaaltiel Y.
Plant Biotechnol J. 2017 Sep;15(9):1120-1129.

read more
Sequential Genome Editing and Induced Excision of the Transgene in N. tabacum BY2 Cells.

Sheva M, Hanania U, Ariel T, Turbovski A, Rathod VKR, Oz D, Tekoah Y, Shaaltiel Y.
Front Plant Sci. 2020 Nov 25;11:607174.

read more

Taliglucerase alfa – clinical experience

Safety and efficacy of two dose levels of taliglucerase alfa in pediatric patients with Gaucher disease.

Zimran A, Gonzalez-Rodriguez DE, Abrahamov A, Elstein D,
Paz A, Brill-Almon E, Chertkoff R.
Blood Cells Mol Dis. 2015 Jan;54(1):9-16.

read more
Long-term efficacy and safety results of taliglucerase alfa through 5 years in adult treatment-naïve patients with Gaucher disease.

Zimran A, Durán G, Giraldo P, Rosenbaum H, Giona F,
Petakov M, Terreros Muñoz E, Solorio-Meza SE, Cooper PA, Varughese S, Alon S, Chertkoff R.
Blood Cells Mol Dis. 2019; Sep;78:14-21.

read more
Pivotal trial with plant cell-expressed recombinant glucocerebrosidase, taliglucerase alfa, a novel enzyme replacement therapy for Gaucher disease.

Zimran A, Brill-Almon E, Chertkoff R, Petakov M,
Blanco-Favela F, Muñoz ET, Solorio-Meza SE, Amato D, Duran G, Giona F, Heitner R, Rosenbaum H, Giraldo P, Mehta A, Park G, Phillips M, Elstein D, Altarescu G, Szleifer M, Hashmueli S, Aviezer D.
Blood. 2011 Nov 24;118(22):5767-73.

read more
Long-term efficacy and safety results of taliglucerase alfa up to 36 months in adult treatment-naïve patients with Gaucher disease.

Zimran A, Durán G, Mehta A, Giraldo P, Rosenbaum H, Giona F, Amato DJ, Petakov M, Muñoz ET, Solorio-Meza SE, Cooper PA, Varughese S, Chertkoff R, Brill-Almon E.
Am J Hematol. 2016 Jul;91(7):656-60.

read more