Deliberate release into the E.U.
environment of GMOs for any other purposes than placing on the
market:
Pluriannuals field experimentations of
genetically modified maize expressing monoclonal antibodies RM2
and RM3 for medical uses in cancerology - France - Meristem
Therapeutics |
Date of publication: February 23,
2005
Source:
http://gmoinfo.jrc.it/gmp_browse_geninf.asp
Notification
report
General information
Notification Number: B/FR/05/03.04
Member State: France
Date of Acknowledgement: 08/02/2005
Title of the Project:
Pluriannuals field experimentations of genetically modified
maize expressing monoclonal antibodies RM2 and RM3 for medical
uses in cancerology
Proposed period of release From:01/04/2005
To:31/10/2006
Name of the Institute(s) or Company(ies): Meristem
Therapeutics;
3. Is the same GMPt release planned elsewhere in the
Community?
No
4 - Has the same GMPt been notified elsewhere by the same
notifier?
No
Genetically
modified plant
1. Complete name of the
recipient or parental plant(s)
|
Common Name
|
Family Name
|
Genus |
Species
|
Subspecies
|
Cultivar/breeding line
|
| maize
|
poaceae |
zea
|
zea
mays |
mays
|
two
populations (one by antibody) |
2. Description of the traits and characteristics which have
been introduced or modified, including marker genes and previous
modifications:
The genes introduced confer to the maize:
- Ability to produce a monoclonal antibody (one by event of
transformation) in seeds
- Tolerance to glufosinate ammonium
There has been no previous genetic modification of the parental
organism.
Genetic
modification
3. Type of genetic
modification:
Insertion;
4. In case of insertion of genetic material, give the source
and intended function of each constituent fragment of the region
to be inserted:
A binary plasmid which was introduced in a disarmed
Agrobacterium strain has been used. The vector contains:
- a gene fusion between a signal peptide sequence isolated from
tobacco pathogenesis related protein and a sequence that encodes
a heavy chain of a human monoclonal antibody directed against
one epitope issued from human cancerous cells. This gene fusion
is under the control of the maize zein promoter (seed specific
expression).
- a gene fusion between a signal peptide sequence isolated from
tobacco pathogenesis related protein and a sequence that encodes
a light chain of a human monoclonal antibody directed against
one epitope issued from human cancerous cells. This gene fusion
is under the control of a promoter derived from the wheat
high-molecular-weight-glutenin promoter (seed specific
expression).
- the bar coding sequence from Streptomyces hygroscopicus. This
gene used as a selective marker confers tolerance to glufosinate
ammonium (constitutive expression).
For each of the two antibodies produced (RM2 and RM3) one heavy
chain and one light chain are expressed.
6. Brief description of the method used for the genetic
modification:
The method used is the biologic transformation by
Agrobacterium tumefaciens.
7. If the recipient or parental plant is a forest tree
species, describe ways and extent of dissemination and specific
factors affecting dissemination:
Not applicable
Experimental
Release
1. Purpose of the release:
The goal of this release is to obtain grains producing these
monoclonal antibodies in order to:
o develop the extraction /purification process at pilot scale,
o produce enough antibodies in order to start pre clinical and
clinical trials,
o confirm biological activity of each of these antibodies
obtained,
o continue the comparison between recombinant antibodies
produced from animal cell culture and from plants,
o compare results obtained with plants from greenhouse and from
field.
2. Geographical location of the site:
In 2005 the release is planned in the center of France (Puy
de Dôme, Auvergne).
3. Size of the site (m2):
15 000 m2 on one site (including non transgenic border rows,
and non transgenic maize used as pollinators).
4. Relevant data regarding previous releases carried out with
the same GM-plant, if any, specifically related to the potential
environmental and human health impacts from the release:
First field release.
Previous greenhouse productions have not shown any particular
behaviour of those GMPts.
Environmental
Impact and Risk Management
Summary of the potential
environmental impact from the release of the GMPts:
- No selective advantage is expected by the expression of
these monoclonal antibodies in seeds of GMPts
- Tolerance to the glufosinate ammonium, is a benefit only if
the herbicide is used.
- There is no wild species sexually compatible with maize in
Europe so potential interspecific crossings are not possible in
these sites. The only potential crossing can be between GMPts
and conventional maize. However this type of crossing is very
improbable due to the fact that measures are taken for the
control of non intentional release in the environment and pollen
dissemination (Cf. paragraph E).
- The in vitro and in vivo experimental studies carried out have
shown the specificity and the efficiency of these antibodies
against certain human cancerous cells. The first assays of
injection to mice have not revealed toxic effect.
- Except the specific cultivation management, the techniques of
cultivation used are the same ones as those usually used for
conventional maize production. So no supplemental effect is
expected for environment.
- To our knowledge, no risks to human and animal health or the
environment from the deliberate release of genetically modified
maize expressing these monoclonal antibodies and tolerance to
glufosinate ammonium herbicide have been reported.
Brief description of any measures taken for the management of
risks:
- Transgenic maize will be detasseled and pollinated by non
transgenic maize.
- Experimental plot will be isolated from any commercial maize
field by at least 200 m.
- At least 4 border rows of non transgenic maize will be sown
all around the experimental plot.
- Destruction by crushing of the residues of culture at the end
of the harvest.
- Monitoring of possible volunteers during one year after
harvest.
- No commercial corn culture will be established on this
experimental field the following year.
- Maize will not be used for feed or food.
The regular follow-up of the trials makes it possible to
identify in an early way any event or development which is not
desirable. Thus the trials can be stopped quickly by the classic
means of destruction (chemical treatment with a conventional
total herbicide other than the glufosinate ammonium or
mechanical treatment with crusher for example).
Summary of foreseen field trial studies focused to gain new
data on environmental and human health impact from the release:
Not applicable |
|
|
|
