ヨーロッパ研究グループ、エイズ薬等生産GM植物開発を計画
04.7.14
ヨーロッパでの薬剤生産遺伝子組み換え（GM）作物開発を目指す”ファーマ・プランタ（Pharma-Planta）”と呼ばれる共同開発事業体が12日、エイズ、狂犬病、結核など、人類にとって最も破滅的な病気のワクチンや治療薬の開発でのGM植物利用を探求する新たな研究計画に、EUが資金を供給すると発表した（全文を末尾に掲げておく）。グループは、ヨーロッパ11ヵ国の31の連携組織を代表する39の学界研究所と産業パートナーと南アフリカの研究者で構成される。この計画はＥＵの第6次研究フレームワーク・プログラム（02-06年）の枠内で採択された研究計画の一つをなし、ＥＵが1,200億ユーロ（約15億6,000万円）の開発基金を提供、09年までに臨床試験に漕ぎつけることを期待しているという。
BBC
NEWS ONLINEによると（EU funding for GM plant vaccines,7.12）、この開発が第一に目指すのは、エイズ伝達を阻止するために利用できる抗体を生産するトモロコシになりそうだ。膣に使用できる殺菌剤クリームに混ぜ込まれることになる。第二の開発目標は、噛まれた後に使う狂犬病ワクチンになりそうだ。
この研究は途上国に最大の利益をもたらすことを目的としており、開発された植物を利用する途上国は、ライセンスなしで自由に利用できるようにする。GM植物の栽培や植物組織から有益な分子を抽出するのに必要な加工も、これら諸国で行われることになる。これにより、現在よりもはるかに安くこれら薬剤を生産できるようになり、貧しい途上国の人々に非常に安価なや薬剤が提供できるようになるという。多くの民間企業は、収益性が期待できないことから、このような開発から手を引いている。ファーマ・プランタは、資金が供給される5年間でそれが開発する技術が、薬剤の世界的供給を促進することを期待している。
遺伝子操作の対象となる植物としては、タバコ、トウモロコシ、ポテト、トマトが候補にあがっており、望ましい蛋白質製品が容易に収穫できる種子に多量に含まれるものが選ばれる。ただし、このような植物は食品安全や環境を脅かす可能性がある。従って、植物は食料作物から隔離された専用の土地で栽培され、花粉を生産しない新たな雄性不稔系統により遺伝的にも隔離されることになる。さらに、加工の第一段階も同じサイトで行われることになろうという。
目的は理解できる。しかし、実用化は、生産から使用に至るまで、あらゆる段階での食品への混入や遺伝子汚染を封じる厳格な規制の実効可能性の十全な評価が絶対の条件となるだろう。
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.'