FP6 - 503565 PHARMA-PLANTA - Recombinant Pharmaceuticals from Plants for Human Health

Contacts
Website: www.pharma-planta.org




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Biotechnology : Crops for Fine Chemicals : Life Science and Food Quality

Type of Project	Integrated Project
Contract No	FP6 - 503565
Total Cost	15,620 KEuro
EC Contribution	12,000 KEuro
Start Date	29-12-2004
Duration	60 Months

Abstract

Pharma-Planta aims to build a plant based production platform for pharmaceuticals in Europe and to enter the first candidate pharmaceuticals into human clinical trials. The programme will develop robust risk-assessment and risk-management practices based on health and environmental impact, and will work with EU regulatory authorities to ensure safety and acceptance.

Plants have enormous potential for the production of recombinant pharmaceutical proteins as they are inexpensive and versatile, amenable to rapid and economical scale-up. The use of GM for the production of pharmaceuticals has precedents, such as human insulin and hepatitis B vaccine, but plant derived materials used in humans have not been formally addressed within the EU. A major goal will be to address the necessary biosafety and regulatory requirements for the use of plant derived pharmaceuticals through a process of engagement and consultation with regulatory bodies involved in GM plants as well as new medicines. The project addresses pharmaceuticals for the prevention of HIV, rabies, tuberculosis and diabetes, that remain significant health problems both in Europe and the developing world.

Pharma-Planta consortium partners represent many of the major laboratories in Europe focusing on the creation of transgenic plants that express important pharmaceuticals for human health. Collectively, the consortium has a wide range of expertise spanning the areas of molecular biology, plant biology, immunology, recombinant protein expression technology, vaccinology, plant biotechnology, risk assessment and IP management. This proposal is a unique opportunity to make an impact on EU and global health through the responsible development of plant biotechnology.

Plants are attractive vehicles for the expression of recombinant pharmaceutical proteins as they are inexpensive and versatile systems, amenable to rapid and economical scale-up. Public opinion in Europe is generally negative towards GM plants, which has led to the loss of many SMEs and commercial development from the Union. However, the use of GM plants for medicines and vaccines rates very highly in terms of public acceptance. With this proposal, our primary aim is to build on previous proof-of-concept studies to develop pharmaceutical products through to clinical trials.

The use of GM pharmaceuticals has precedents, such as human insulin and hepatitis B vaccine, but plant-derived materials used in humans has not been formally addressed within the EU. A major outcome will be to define the regulatory requirements through a process of engagement and consultation with all relevant regulatory bodies (involved in GM plants as well as new pharmaceuticals), in order to move through clinical trials and gain permission for the use of plant derived pharmaceuticals in practice. Monoclonal antibodies will be the first generation of molecules to be developed for Phase I clinical evaluation, and we include 2 neutralising antibodies each for HIV and rabies.

The proposal also includes a limited range of other targets, against HIV, TB and diabetes, and for some of these, new expression strategies will need to be developed. They represent the second-generation molecules, which will feed the development pipeline for SMEs in Europe, beyond the lifetime of the project. In each case, plant-based systems offer a real advantage, if not the only option for production on a scale relevant to the needs for that molecule. Alongside our principle aim of developing plant derived recombinant pharmaceuticals, we recognise the need to put in place comprehensive risk assessments based on health and environmental impacts, and to work with EU regulatory authorities.

Coordinator

Fraunhofer Institute of Molecular Biology and Applied Ecology, Germany

Partners

• St George's Hospital Medical School, UK
• Rheinisch-Westfälische Technische Hochschule, Germany
• National University of Ireland, Ireland
• John Innes Centre, UK
• Centre de Cooperation Internationale en Research Agronomique pour le Development (CIRAD), France
• Oxford Brookes University, UK
• University of Warwick, UK
• Universität für Bodenkultur, Vienna, Austria
• Polymun Scientific Immunbiologische Forschungs GmbH, Austria
• Universita Degli Studi di Verona, Italy
• Ente per le Nuove Technologie, l'Energia e l'Ambriente, Italy
• Diamyd Medical AB, Sweden
• Universite Blaise Pascal Clermont-Ferrand II, France
• Institut National de la Recherche Agronomique, France
• University of Cambridge, Cambridge, UK
• University of Glasgow, UK
• Ruprecht-Karls-Universität Heidelberg, Germany
• Universite Catholique de Louvain, Belgium
• University of Leeds, UK
• Consiglio Nazionale Delle Ricerche, Rome, Italy
• Council for Scientific and Industrial Research, South Africa
• Rothamstead Research Ltd, UK
• Universite de Neuchatel, Switzerland
• Max Planck Institute, Germany
• Trinity College Dublin, Republic of Ireland
• Institut für Pflanzengenetik und Kulturpflanzenforschung, Germany
• Vlaams Interuniversitair Instituut voor Biotechnologie , Belgium
• Agricultural University of Athens, Greece
• Centre for the Management of Intellectual Property in Health research and Development, United Kingdom
• Mosaic Systems BV, Prinsenbeek, The Netherlands
• Univeritat de Lleida, Spain

Contacts

Cordinator

• Rainer FISCHER / RWTH Aachen Molecular Biotechnology / GERMANY

Project manager

• Richard TWYMAN / University of York Department of Biology / UNITED KINGDOM