[e-drug] plant based vaccines and/or antibodies against major diseases?

[e-drug@healthnet.org]

E-DRUG: plant based vaccines and/or antibodies against major diseases?
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[Thanks to Seco for spotting this; WB]

Research and pharmaceuticals: EU 'pharming' solutions to major diseases.
22.7.2004.

A team of European researchers plans to perfect techniques for producing
antibodies and vaccines, obtained from plants, to prevent and treat major
human diseases, such as AIDS, rabies and TB. The idea is to use genetically
modified (GM) crops eventually to produce plant-based pharmaceuticals.
Pharma-Planta is a consortium of eleven European countries and South Africa
which, thanks to ?12 million in EU funding, plans to produce vaccines and
other treatments for major diseases, such as HIV/AIDS, rabies and
tuberculosis. The project, led by the Fraunhofer Institute for molecular
biology and ecology in Aachen (Germany), with scientific co-ordination by
St. George's Hospital Medical School in London( UK), hopes to start clinical
trials by the end of the funding period in 2009.

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For more info: http://www.pharma-planta.org/ and press release pasted
bellow.

News from the Pharma-Planta Consortium

July 12th 2004. Pharma-Planta press release concurrent with website launch

The Pharma-Planta project was officially introduced to the public today with
simultaneous press releases in the UK and Germany, and the concurrent launch
of the Pharma-Planta website. The contents of the press release are shown
below:


European Pharma-Planta research consortium to tackle major human diseases
using GM plant-derived pharmaceuticals

The European Union has funded a major new research program to explore the
use of genetically modified plants in the development of treatments for some
of mankind's most devastating diseases, including AIDS, diabetes, rabies and
tuberculosis.

Research organizations in eleven EU countries and South Africa will share
the ?12 million award, and will use the money to perfect techniques for the
production of antibodies and vaccines that can be used to prevent or treat
these important human diseases. The Scientific Coordinator of the project,
Professor Julian Ma (St. Georges Hospital, London UK) and the Administrative
Coordinator, Professor Rainer Fischer (Fraunhofer IME, Aachen, Germany)
explain why the project focuses on plants as the production system:
'Infectious diseases are the leading cause of death in children and the
second highest cause in adults, says Ma. 'These diseases primarily affect
people in developing countries who do not have access to and cannot afford
the medicines and vaccines that are on sale in developed countries'. Fischer
adds: 'There is a desperate need to find ways to produce modern medicines in
sufficient quantities and at a cost that would make them available to
everyone. We believe that using plants to make pharmaceuticals could make a
significant contribution.'

Many scientists have used plants to produce antibodies and vaccines in the
laboratory in proof of concept studies, but no-one has yet addressed the
later stages of production and formulation. Ma and Fischer continue: 'While
the production of pharmaceuticals in genetically modified mammalian cells
and microbes is well-established and documented, there are no precedents for
the same production process in plants. The unique aim of the Pharma-Planta
consortium is to demonstrate the entire process, from conception and gene
synthesis, through plant transformation and into clinical trials. We aim to
establish the procedures and materials for the complete production pipeline,
working closely with European regulatory agencies to ensure safety and
compliance at all stages.'

Regulation is a critical aspect of the project, since the production of
pharmaceuticals in genetically modified plants is subject to control by
multiple regulatory agencies, including those governing the use of GM
organisms and those governing the production of drugs. Therefore, a
considerable proportion of the Pharma-Planta budget has been set aside to
explore different methods and places for production, which will include
production in containment as well as under field conditions. Professor
Philip Dale, the project's Biosafety Coordinator, explains: 'The consortium
is undertaking a major consultation exercise to develop the most appropriate
production system. We have several different systems under consideration
including maize and tobacco. We are evaluating these systems very carefully
and a final decision will not be made until about a year into the project'.
The production site is also important, and here again the consortium is
keeping its options open. 'We have several production sites in mind,' Dale
continues, 'both inside and outside the EU. As part of this review, the
Council for Scientific & Industrial Research in South Africa has come
forward for consideration, as it has a particular interest in the
development of pharmaceuticals for the treatment of HIV/AIDS. Various
factors will influence the choice of location for pilot field production,
including safety, robust regulation, site security and the appropriate human
resources.'

There are nearly 40 research groups involved in various stages of the
project, coordinated by administrative bodies at the Fraunhofer Gesellschaft
in Munich, Germany. The integrated project is part of the EU's 6th Framework
Programme which aims to promote collaboration between outstanding centers of
research and end users in the development of new ideas and products.
According to Fischer, the justification for such a large consortium is the
requirement for expertise in so many different areas. Each stage of
development will be handled by a different set of partners working on a
subdivision of the overall project's objectives, but there will be extensive
interaction between the various working groups to ensure the project goes
smoothly to schedule. Although five years of funding have been obtained, the
enormity of the project means the timeline is actually very tight. The
groups responsible for the first stage of the process, transferring the
vaccine and antibody genes into plants, are already hard at work and the
first plant material for analysis should be available in a few months. The
pharmaceuticals will be extracted from these plants and tested extensively
while the processing and purification stages of the development pipeline are
refined. Ultimately, the aim is to obtain antibodies and vaccines of
sufficient purity and quantity for clinical trials.

It will be a long time before the products of these pharmaceutical plants
can be used by doctors to combat disease. If the production pipeline can be
perfected in the five-year duration of the project, the active
pharmaceutical ingredients then have to undergo an extensive series of
safety and clinical trials before they are approved and licensed, and this
could also take several years. Nevertheless, the researchers engaged in the
EU Pharma-Planta project are optimistic. 'Our project will take us all the
way to the first clinical trials,' says Ma, 'which is further than anyone
has gone before.' Fischer concludes: 'By that stage, we aim to show that
plants can be used safely to produce pharmaceuticals, and that this can be
achieved while adhering to all regulatory requirements. That is our primary
goal.'

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