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January 6 2005. Pharma-Planta consortium scientists sign up to Statement of Intent on Humanitarian Use.

Pharmaceuticals derived from plants have the potential to benefit human health everywhere in the world. No other production system can match plants in terms of economy and scale of production. For possibly the first time, a technology is available that will allow the large-scale production of modern medicines in a manner that will benefit poor populations in developing countries, the people who need these medicines the most. One of the main areas of emphasis for the Pharma-Planta Consortium, which aims to build a plant-based production platform for pharmaceuticals, is to make an impact on global health, particularly in developing countries. To this end, we are developing scientific knowledge, enabling technologies and products that specifically address health needs of the poor in developing countries. It is recognised that provision must be made to help ensure that our products will be made readily available to the poor. All members of the Pharma-Planta Consortium have therefore signed up to a Statement of Intent on Humanitarian Use that promises to make the work from our program freely available for the achievement of humanitarian purposes.

 

July 12 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.

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.'