Table 7 Examples of plant-based protein pharmacological entities at various stages of clinical
trials
Product/application
Plant host
Status
Company
(sponsor)
Taliglucerase alfa (Human
glucocerebrosidase, prGCD)
ERT for Gaucher’s disease
Daucus carota
(carrot) cell
culture
NCT00376168
Phase III (completed in
2012)
FDA-approved in 2012
Protalix
BioTherapeutics,
Israel/Pfizer
Moss-aGal (Human alphagalactosidase A)
ERT for Fabry disease
Physcomitrella
patens (moss)
NCT02995993
Phase I
Greenovation
Biotech GmbH,
Germany
PRX-102 (Human alphagalactosidase A)
ERT for Fabry disease
NCT01769001
Tobacco cell
culture
Phases I and II
Protalix
BioTherapeutics,
Israel Recombinant human intrinsic
factor
Dietary supplement for
vitamin B12 deficiency
Arabidopsis
thaliana
NCT00279552
Phase II (completed in
2006)
University in
Aarhus, Denmark
Recombinant lactoferrin
Anti-inflammation treatment
for HIV patients
Oryza sativa
(rice)
NCT01830595
Phase II (completed in
2006)
Jason Baker
(MMRF), USA
rhLactoferrin
Treatment for chronic
inflammation in the elderly
Rice
NCT02968992 Phase II Johns Hopkins
University, USA
Locteron (controlled-release
interferon alpha 2b)
Antiviral treatment for hepatitis C virus infection
Lemna minor
(duckweed)
NCT00593151
Phases I and II (completed in 2009)
Biolex
Therapeutics, USA
Interberry-alpha
Canine interferon-alpha
treatment of periodontal
disease in dogs
Strawberry
(stable)
Manufacturing and
marketing approval by
the Japanese Ministry of
Agriculture, Forestry
and Fisheries
NIAIST Institute
(Japan)
Table 8 The main GMP factories for the production of plant-made biopharmaceuticals
Company
Plant/expression
system
Main biopharmaceutical product
Kentucky Bioprocessing (USA)
Potato (stable)
Tobacco (transient)
Norovirus vaccine
Ebola virus vaccine (ZMapp)
SIGMA Aldrich (USA)
Maize (stable)
Trypsin
Medicago Inc. (Canada)
Tobacco (transient)
Influenza vaccine
Protalix/Pfizer (Israel)
Carrot (stable)
Taliglucerase alfa
Fraunhofer (CMB-USA/IMEGermany)
Tobacco (transient,
stable)
Influenza vaccine, anti-HIV
antibodies
NIAIST Institute (Japan)
Strawberry (stable)
Canine interferon-alpha
Tokyo University (Japan)
Rice (stable)
Cholera toxin B subunit
92
S. Massa et al.