Publications

Publications
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Publications

Selected scientific publications co-authored by Protalix employees

ProCellEx® Platform

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)

Plant specific N-glycans do not have proven adverse effects in humans.
Shaaltiel Y,  Tekoah Y.
Nat Biotechnol. 2016 Jul(pp,.1-3)

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)

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)

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)

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 I,   Shulman A,   Kizhner T,   Azulay Y,   Nataf Y,   Tekoah Y,   Shaaltiel Y.
Bioconjug Chem. 2018 (pp.1-8)

Characterization of a chemically modified plant cell culture expressed human α-Galactosidase-A enzyme for treatment of Fabry disease.
Kizhner T,  Azulay Y,  Hainrichson M,  Tekoah Y,  Arvatz G,  Shulman A,  Ruderfer I,  Aviezer D,   Shaaltiel Y.
Mol Genet Metab. 2015(pp.1-9)

OPRX-106 

An oral administration of a recombinant anti-TNF fusion protein is biologically active in the gut promoting regulatory T cells: Results of a phase I clinical trial using a novel oral anti-TNF alpha-based therapy.
Almon E,  Khoury T,  Drori A,  Gingis-Velitski S,  Alon S,  Chertkoff R,  Mushkat M,  Shaaltiel Y,  Ilan Y.
J Immunol Methods. 2017(pp.1-9)

The taliglucerase alfa story

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(pp.1-18)

 Taliglucerase alfa: an enzyme replacement therapy using plant cell expression technology.
Grabowski GA,  Golembo M,  Shaaltiel Y.
Mol Genet Metab. 2014 May (pp.1-8)

Glycosylation and functionality of recombinant β-glucocerebrosidase from various production systems.
Tekoah Y,  Tzaban S,  Kizhner T,  Hainrichson M,  Gantman A,  Golembo M,  Aviezer D,  Shaaltiel Y.
Biosci Rep. 2013(pp.1-13)

Crystal structures of complexes of N-butyl- and N-nonyl-deoxynojirimycin bound to acid beta-glucosidase: insights into the mechanism of chemical chaperone action in Gaucher disease.
Brumshtein B,  Greenblatt HM,  Butters TD,  Shaaltiel Y,  Aviezer D,  Silman I,  Futerman AH,  Sussman JL.
J Biol Chem. 2007(pp.1-7)

Production of glucocerebrosidase with terminal mannose glycans for enzyme replacement therapy of Gaucher’s disease using a plant cell system.
Shaaltiel Y,  Bartfeld D,  Hashmueli S,  Baum G,  Brill-Almon E,  Galili G,  Dym O,  Boldin-Adamsky SA,   Silman I,  Sussman JL,  Futerman AH,  Aviezer D.
Plant Biotechnol J. 2007(pp.1-12)

Taliglucerase alfa – clinical experience

Long-term efficacy and safety results of taliglucerase alfa through 5years 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. 2016(pp1-5)

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(pp.1-5)

Enzyme replacement therapy with taliglucerase alfa: 36-month safety and efficacy results in adult patients with Gaucher disease previously treated with imiglucerase.
Pastores GM,  Shankar SP,  Petakov M,  Giraldo P,  Rosenbaum H,  Amato DJ,  Szer J,  Chertkoff R,   Brill-Almon E,  Zimran A.
Am J Hematol. 2016(pp.1-6)

Long-term efficacy and safety results of taliglucerase alfa through 5years 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. 2016 (pp.1-8)

Pharmacokinetics of Novel Plant Cell-Expressed Taliglucerase Alfa in Adult and Pediatric Patients with Gaucher Disease.
Abbas R,  Park G,  Damle B,  Chertkoff R,  Alon S.
PLoS One. 2015(pp.1-10) 

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(pp.1-8)

A Phase 3, multicenter, open-label, switchover trial to assess the safety and efficacy of taliglucerase alfa, a plant cell-expressed recombinant human glucocerebrosidase, in adult and pediatric patients with Gaucher disease previously treated with imiglucerase.
Pastores GM,  Petakov M,  Giraldo P,  Rosenbaum H,  Szer J, Deegan PB,  Amato DJ,  Mengel E,  Tan ES,  Chertkoff R,  Brill-Almon E,  Zimran A.
Blood Cells Mol Dis. 2014(pp.1-8)

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(pp.1-8)

A plant-derived recombinant human glucocerebrosidase enzyme–a preclinical and phase I investigation.
Aviezer D,  Brill-Almon E,  Shaaltiel Y,  Hashmueli S,  Bartfeld D,  Mizrachi S,  Liberman Y,  Freeman A,  Zimran A,  Galun E.
PLoS One. 2009(pp.1-6)