In June 2011, medical regulators gave the go-ahead for trials in humans of
a potential new anti-HIV drug. The drug was produced in genetically modified
It was the first ever clinical trial of a drug of this type that had been derived from
The hope is that the drug will prove effective
in preventing HIV infection. But the real
significance of the regulatory green light,
given by the UK's licensing body, the Medicines
and Healthcare products Regulatory Agency
(MHRA), went further than that.
It confirmed, for the first time, that molecules
known as monoclonal antibodies – the key
component of the drug, and of many other
highly effective modern pharmaceuticals
- could be produced from plants in a form
that met the extremely stringent standards
required for use in the treatment of humans.
As well as bringing hope to the fight against
HIV/AIDS, the decision opened the way for
trials of other plant-derived medicines to
treat a range of diseases.
It was, potentially, an important step towards
the transformation of modern drug manufacturing,
offering the developing world access to
key drugs which have previously been prohibitively
The move to Phase 1 clinical trials was the
crowning achievement of PHARMA-PLANTA,
a seven-and-a-half year EU-funded project
set up in 2004. With € 12 million of funding
provided under the EU's 6th Framework
Programme of research and development,
the PHARMA-PLANTA consortium comprised
more than 30 academic and industrial
partners from across Europe and South
Africa. The consortium's goal was clearly
stated: to develop a manufacturing process
for recombinant protein drug products derived
from GM plants and to take one such product
through all the development stages, including
The approval from the MHRA was described by
the project's scientific co-ordinator, Professor
Julian Ma of St. George's, University of London,
as "a red letter day". It was, he said, "an
acknowledgement that monoclonal antibodies
can be made in plants to the same quality
as those made using existing conventional
production systems. That is something many
people did not believe could be achieved."
The conventional production systems referred
to by Professor Ma use sophisticated stainless
steel fermentation vats containing bacteria
or mammalian cells. The process of deriving
antibodies from these cells is high-tech - and
By contrast, the antibodies produced by
PHARMA-PLANTA were derived from tobacco
plants grown in greenhouses in Germany,
harvested after 45 days and shredded.
According to Professor Rainer Fischer, Director
of the institute where the GM tobacco was
grown, this much simpler, more low-tech
option is between 10 and 100 times cheaper.
Just as importantly, the simplicity of the
process means it could easily be transferred
to developing countries, allowing production
of drugs "in the region, for the region."
Discovered by one of the four private
commercial partners in the project, Austrian
biotech company Polymun, the new antibody
successfully completed its Phase 1 trial,
ascertaining its safety, at the end of 2011.
It is now set to move into the next phase of
testing, to establish its medical effectiveness.
Meanwhile, other diseases for which it is
envisaged that GM plants could provide new
drugs include cancer, rheumatoid arthritis and
others which, in the words of Professor Ma, are
currently "horribly expensive" to treat.
As Professor Fischer explains, the success of
PHARMA-PLANTA "is a springboard for European
plant biotechnology and will enable many
important medical products to be realised".