Agriculture Reference
In-Depth Information
UnitedStatesandCanada:EarlyStarters
Most commercial activity has so far been centered in North America.
More than four hundred experimental field trials in the United States
and Canada with GM crops producing PMPs or PMIs
14
have been con-
ducted, which indicates commercial interests. Another indicator is clin-
ical trials: sixteen PMPs were recently reported to be in various stages
of clinical trials
15
with about ten products - including veterinary drugs -
moving closer to market stage (see Table 1).
16
Horn
17
anticipates mar-
ket approval for twelve products from plants, including vaccines, anti-
bodies, and enzymes by 2009. The process of market commercialization,
however, turned out to be much slower. In 2006, a poultry vaccine from
plant cell culture was the first PMP that achieved regulatory approval.
18
Another promising PMPs, a safflower-derived human insulin advanced
to phase 3 clinical trials
19
and a carrot-cell culture-derived human glu-
cocerebrosidase for treating Gaucher's disease, successfully completed
phase 3 clinical trials in 2009. Some enzymes and other substances are
already produced on a small scale through molecular farming for com-
mercial use as fine chemicals.
20
Consequently, the North American PMP developers are now eager
to obtain a green light for commercial production, which would
include open field production in food crops. Therefore, they hope to
14
See www.isb.vt.edu/cfdocs/fieldtests1.cfm; www.inspection.gc.ca/english/plaveg/bio/
mf/sumpnte.shtml.
15
PHARMA-PLANTA, Molecular Farming for New Drugs and Vaccines. 6
EMBO
Reports
, 593-599 (2005).
16
This also includes two products from EU-based companies, Meristem Therapeutics
and Cobento, the former of which is conducting field trials in the USA, Chile, and
Europe.
17
M. E. Horn et al., Plant Molecular Farming: Systems and Products. 22
Plant Cell
Reports
711-720 (2004).
18
See www.dowagro.com/newsroom/corporatenews/2006/20060131b.htm.
19
A. Sp ok et al., Evolution of a regulatory framework for pharmaceuticals derived from
genetically modified plants. 26(9)
Trends in Biotechnology
506-517 (2008).
20
A. Sp ok &M. Klade, Molecular Farming. Novel Challenges for Risk Management and
Legislation (Office of Technology Assessment at the German Parliament 2005).
