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SCIENCE & PLANTS: Anti-HIV drug made by GM plants begins UK trials in humans



                                  PART 1


------------------------------- GENET-news -------------------------------

TITLE:   ANTI-HIV DRUG MADE BY GM PLANTS BEGINS TRIALS IN HUMANS

SOURCE:  The Guardian, UK

AUTHOR:  Sarah Boseley

URL:     http://www.guardian.co.uk/science/2011/jul/19/anti-hiv-drug-gm-plants

DATE:    19.07.2011

SUMMARY: "An antiviral drug synthesised by genetically modified plants is being tested on a small number of women in the UK to establish its safety, bringing closer the possibility of cheap modern medicines for the developing world. The drug?s developers hope it can be used to prevent HIV infection, but the real breakthrough is that the research demonstrates it is possible for similar molecules ? known as monoclonal antibodies ? to be produced relatively cheaply in plants to the high standards needed for their use in humans. [...] Pharma-Planta is a project launched seven years ago with the objective of using GM plants to slash the cost of drugs that are hard to produce."

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ANTI-HIV DRUG MADE BY GM PLANTS BEGINS TRIALS IN HUMANS

An antiviral drug synthesised by genetically modified plants is being tested on a small number of women in the UK to establish its safety, bringing closer the possibility of cheap modern medicines for the developing world.

The drug?s developers hope it can be used to prevent HIV infection, but the real breakthrough is that the research demonstrates it is possible for similar molecules ? known as monoclonal antibodies ? to be produced relatively cheaply in plants to the high standards needed for their use in humans.

The human trial has been approved by the UK licensing body, the Medicines and Healthcare products Regulatory Agency (MHRA), and is taking place in Guildford at the clinical research centre of the University of Surrey.

Pharma-Planta is a project launched seven years ago with the objective of using GM plants to slash the cost of drugs that are hard to produce. The scientists? aim is to increase the availability of these modern medicines ? which are often highly effective ? in the poorest countries of the world.

Access to medicines in the developing world is extremely limited. The World Health Organization estimates that 23 million infants worldwide do not get adequate basic immunisation and 1.7 million children under five die from vaccine-preventable diseases.

?The driver was to produce these medicines economically and at a level that would satisfy global demand,? said Professor Julian Ma from St George?s University, London, who is the joint co-ordinator of the European Union-funded project.

Many medicines are synthesised at great expense in fermentation vats containing bacteria or mammalian cells. By contrast Pharma-Planta produced the anti-HIV monoclonal antibody in GM tobacco plants grown in soil in greenhouses in Germany. After 45 days, they were harvested, their leaves were shredded and ?highly purified antibodies? were extracted.

The researchers say there is little risk of such GM plants spreading or contaminating other crops because they are contained and would not be grown on anything like an agricultural scale.

Ma said it was ?a red letter day? when they received the go-ahead from the drugs regulator. ?The approval from the MHRA for us to proceed with human trials is 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,? he said.

Eleven healthy women have volunteered to take part in the trial and two of them have been given the antibody so far, with a third woman having been given a placebo. The trial is designed only to demonstrate the safety of the antibody, called P2G12, at different dosages. Much bigger trials in women at risk of contracting HIV would be necessary to test whether it could prevent infection.

If it does prove effective, the drug would probably have to be used in combination with other monoclonal antibodies to minimise the chance that the virus developed resistance, as it easily does to antivirals.

The process is between 10 and 100 times cheaper than conventional production systems, said Professor Rainer Fischer of the Fraunhofer Institute for Molecular Biology and Applied Ecology in Aachen, Germany, where the plants were grown.

The most useful monoclonal antibodies, such as the anti-cancer drug Herceptin, are still covered by patents owned by major pharmaceutical companies, but once these expire the new technique could offer a way to make cheap versions available in poor countries.



                                  PART 2

------------------------------- GENET-news -------------------------------

TITLE:   TESTS START ON HIV BIOTECH DRUG - GROWN IN TOBACCO

SOURCE:  Thomson Reuters, USA

AUTHOR:  Ben Hirschler

URL:     http://in.reuters.com/article/2011/07/19/us-biotechnology-tobacco-hiv-idINTRE76I4HL20110719

DATE:    19.07.2011

SUMMARY: "In a first for European drug research, scientists have launched a clinical trial of an anti-HIV biotech medicine produced using genetically modified tobacco -- a plant better known for ruining human health. The move marks an advance in the emerging field of molecular farming, which may offer a cheaper way of making complex biotech drugs and vaccines than traditional factory systems."

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TESTS START ON HIV BIOTECH DRUG - GROWN IN TOBACCO

(Reuters) - In a first for European drug research, scientists have launched a clinical trial of an anti-HIV biotech medicine produced using genetically modified tobacco -- a plant better known for ruining human health.

The move marks an advance in the emerging field of molecular farming, which may offer a cheaper way of making complex biotech drugs and vaccines than traditional factory systems.

Following a green light from regulators, the monoclonal antibody is being tested in a small study involving 11 healthy women in Britain. It is designed for use as a vaginal microbicide to prevent HIV transmission during sex.

If the Phase I study is successful, larger trials will follow and researchers envisage the new antibody, P2G12, will be combined with others in a microbicide offering broad protection against HIV/AIDS.

The trial is a milestone for the Pharma-Planta project which was launched in 2004 with 12 million euros ($16.8 million) of European Union funding.

At the moment, costly antibody drugs, such as Roche?s cancer treatments Herceptin and Avastin, are produced in cell cultures inside stainless steel tanks.

Advocates of molecular farming believe such protein drugs could be made more efficiently and cheaply inside genetically modified (GM) crops, since plants are extremely cost-effective protein producers.

Project co-ordinator Julian Ma, professor of molecular immunology at St George?s, University of London, told reporters on Tuesday the green light for the trial was an acknowledgement that antibodies could be made in plants to the same quality as those made in factories.

The antibody being tested was discovered by private Austrian biotech Polymun.

?HORRIBLY EXPENSIVE?

Ma said he hoped the lower-cost technology would eventually be transferred to poor countries, giving them access to biotech medicines for cancer, rheumatoid arthritis and some infections that are currently ?horribly expensive.?

?This opens the potential for plants to manufacture a range of drugs in the developed, and the developing, world,? he said.

Rainer Fischer, head of the Fraunhofer Institute for Molecular Biology and Applied Ecology in Aachen, Germany, where the tobacco plants were grown, said production costs would be at least 10 times lower than using conventional bioreactors.

Genetic modification remains a sensitive topic in Europe, where there is widespread opposition to GM foods.

But Ma said he did not expect public resistance to using GM plants in medicine, given the plants would be grown in contained greenhouses and that tobacco is not part of the food chain.

Still, major drugmakers may be reluctant to rush into the disruptive new technology, given their existing investment in stainless steel bioreactors which have recently seen a marked increase in yields, thanks to improved efficiencies.

Some large companies have been looking at ways to make complex protein drugs in plants but molecular farming has yet to deliver its first commercial product.

The closest is a Gaucher disease drug from Israel?s Protalix BioTherapeutics and Pfizer, which is produced in a culture of carrot cells -- rather than in whole plants -- and has been filed for approval.

U.S. regulators said in February they needed more data on the product before deciding whether to give it a green light.

Bayer is also conducting research in the United States on tobacco-based treatment for non-Hodgkin?s lymphoma, a type of blood cancer.

($1 = 0.713 Euros) (Editing by David Hulmes)



                                  PART 3

------------------------------- GENET-news -------------------------------

TITLE:   CLINICAL TESTS FOR MEDICINES MADE FROM GENETICALLY MODIFIED PLANTS

SOURCE:  Fraunhofer-Gesellschaft, Germany

AUTHOR:  Press Release

URL:     http://www.fraunhofer.de/en/press/research-news/2010-2011/19/clinical-tests.jsp

DATE:    19.07.2011

SUMMARY: "UK regulators have approved Europe?s first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases. The trial will test the safety of a plant-derived antibody designed to stop the transmission of HIV between sexual partners when applied directly to the vaginal cavity."

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CLINICAL TESTS FOR MEDICINES MADE FROM GENETICALLY MODIFIED PLANTS

Pharmaceuticals can be produced by plants. Antibodies that have been produced in tobacco plants will now for the first time be tested in a clinical study. The decision was announced at a press conference in London on Tuesday July 19th 2011.

UK regulators have approved Europe?s first clinical trial of a monoclonal antibody produced from genetically modified plants. This landmark decision sets the stage for the testing, in humans, of an anti-HIV product made from genetically modified tobacco plants. It will open the door for trials of additional plant-derived medicines treating a range of diseases.

The trial will test the safety of a plant-derived antibody designed to stop the transmission of HIV between sexual partners when applied directly to the vaginal cavity. If proven safe in the 11 participants, the researchers can then go on to test the effectiveness of the product.

The clinical trial marks the culmination of the EU Framework 6 Pharma-Planta project, which was launched by a consortium of 30 academic and industrial partners in 2004 with ?12 million in funding from the European Union. The primary goal was to develop an approved manufacturing process for recombinant pharmaceutical proteins made in plants and take one such product through all the development stages including the pivotal clinical trial.

Most biopharmaceuticals are currently made at great expense in fermentation vats containing bacteria or mammalian cells, but the mass production of medicines in genetically modified plants could reduce costs and therefore make an important contribution to global health, by improving access for the poor in developing countries where diseases such as HIV are a huge problem. In addition, the simple manufacturing process could be transferred to developing countries allowing production ?in the region for the region?.

The approval granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) is a significant step forwards because it means a plant-based production system can comply with current Good Manufacturing Practice, the strict standards used in the industry to ensure medicine quality and consistency.

Professor Julian Ma, scientific coordinator for Pharma-Planta and Professor of Molecular Immunology at St George?s, University of London, said: ?This is a red letter day for the field. The approval from the MHRA for us to proceed with human trials is 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 not be achieved.?

The clinical trial ? which is being carried out at the University of Surrey Clinical Research Centre ? will test a topically-applied anti-HIV microbicide. The active ingredient in the microbicide is a monoclonal antibody called P2G12. If successful, the investigators envisage that P2G12 will be used in combination with other HIV-neutralising antibodies, also produced in plants, to create a broadly protective vaginal microbicide product.

The genetically modified tobacco plants producing P2G12 were grown in state-of-the-art containment greenhouses at the Fraunhofer Institute for Molecular Biology and Applied Ecology, IME in Aachen, Germany, and the antibody was isolated and purified in a custom-designed processing plant on the same site, the first of its kind to be granted a license to manufacture recombinant pharmaceutical products from plants in Europe.

Professor Rainer Fischer, Pharma-Planta coordinator and Fraunhofer IME Director, said: ?We now have a facility in Europe for producing modern medicines in transgenic plants that is unique in the world, although this has taken many years and much investment to establish. This approval is a springboard for European plant biotechnology and will enable many important medical products to be realised.?