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[genet-news] POLICY & REGULATION: GM mosquitoes wipe out dengue fever in trial



                                  PART 1


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TITLE:   GM MOSQUITOES WIPE OUT DENGUE FEVER IN TRIAL

SOURCE:  Nature News, UK

AUTHOR:  

URL:     http://blogs.nature.com/news/thegreatbeyond/2010/11/gm_mosquitoes_wipe_out_dengue.html

DATE:    11.11.2010

SUMMARY: "They released around 3.3 million sterile males over the 6 month study period, and found that the wild populations were reduced by 80% as a result - a level sufficient to effectively wipe out dengue fever in the area. ?We saw a significant reduction in the target population?, Luke Alphey chief scientific officer and founder of Oxitec said. The GM males are engineered to die off in the wild, and so - Oxitec says - they do not pose a risk by persisting in the environment."

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GM MOSQUITOES WIPE OUT DENGUE FEVER IN TRIAL

The controlled release of male mosquitoes genetically engineered to be sterile has successfully wiped out dengue fever in a town of around 3000 people, in Grand Cayman, an island in the Caribbean Sea, researchers report.

The release is the first field trial of GM dengue-carrying mosquitoes (Aedes aegypti) developed by scientists at Oxitec, a UK-based company founded and part-owned by the University of Oxford. (You can see a video of the release here.) The researchers reported the findings of the study, which ran from May to October this year, on 4 November and briefed journalists about the research at a press meeting today in London.

Dengue fever is a debilitating disease carried by biting female A.aegypti mosquitoes and causing around 25,000 human deaths a year. It mainly occurs in the tropics, but it is spreading to other climes. Paul Reiter, a medical entomology at the Pasteur Institute in Paris, told reporters that a case was reported in Holland around 4 weeks ago, and two cases have been reported in the south of France this year.

Current control methods, including bed nets and insecticides, have proved unsuccessful in controlling the disease. In addition, a vaccine has not yet been developed, and is unlikely to be available for at least 10 years, Reiter said.

Many agricultural pests are controlled through the release of sterile males. They mate with wild females and but do not produce viable offspring, and so the population size falls. If numbers drop far enough, the disease they carry can?t spread.

Traditionally, males are sterilised by exposing them to radiation. But A.aegypti proved to be highly sensitive to the radiation, to the extent that they were unable to compete successfully with their wild counterparts for mates. So instead the researchers decided to tweak the mosquitoes? genes to induce sterility. And it worked. The wild females liked the GM males just as much as their fertile counterparts.

They released around 3.3 million sterile males over the 6 month study period, and found that the wild populations were reduced by 80% as a result - a level sufficient to effectively wipe out dengue fever in the area. ?We saw a significant reduction in the target population?, Luke Alphey chief scientific officer and founder of Oxitec said.

The GM males are engineered to die off in the wild, and so - Oxitec says - they do not pose a risk by persisting in the environment. The females will only mate with males of the same species, so the genetically modified trait cannot spread to other species.

Alphey said a number of other countries have expressed interest in the technology including Brazil, Panama and Malaysia, the latter of which will begin fields trials in the next few months.



                                  PART 2

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TITLE:   GM MOSQUITO: STRINGENT PROTOCOLS IN PLACE

SOURCE:  Malaysia Kini, Malaysia

AUTHOR:  Yamuna Perimalu

URL:     http://www.malaysiakini.com/letters/147700

DATE:    09.11.2010

SUMMARY: "The Environmental Impact Statement by the United States Department of Agriculture on the release of insects carrying dominant lethal gene (RIDL), i.e. GM pink bollworm and GM fruit fly was also reviewed and taken into consideration as this RIDL technology is similar to that applied in the production of GM mosquitoes. Through Risk Assessments, the USDA has proven that the release of GM organisms is safe to human and the environment when the release is conducted in a proper manner."

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GM MOSQUITO: STRINGENT PROTOCOLS IN PLACE

Yamuna Perimalu is writing on behalf of the Corporate Communications Unit, Ministry Of Natural Resources & Environment Malaysia.

We (Ministry Of Natural Resources & Environment Malaysia) refer to the article 'Why the rush to unleash GM mosquitoes on rakyat?' (Malaysiakini, Nov 8).

We appreciate the concerns raised by SM Mohamed Idris, President, Consumers' Association of Penang and Sahabat Alam Malaysia with regards to this issue.

The World Health Organisation only develops guidelines for field testing and release of GM insects, but it is up to Malaysia to adopt and adapt it in order to establish our own guidelines.

In fact the Ministry Of Natural Resources and Environment Malaysia used the guidelines developed for GM Mosquito under the Cartagena Protocol on Biosafety.

We wish to inform that the approval process is not as simple as it is made out to be by some parties, as approval is given on a case by case basis and based on the merits of the application.

In the case of the GM mosquito application, the application went through a few reviews within the institution itself, i.e. the Research Review Committee, the Medical Research and Ethics Committee and the Institutional Biosafety Committee, before being submitted to the Department of Biosafety.

Within the Department of Biosafety itself, the application went through the Genetic Modification Advisory Committee (GMAC) (several rounds of consultations) before forwarding GMAC's recommendation to the National Biosafety Board (NBB).

This whole process itself has taken about five years before obtaining an approval from the NBB. This includes the laboratory and semi-field containment trials conducted.

A thorough scientific analysis on all aspects of safety is carried out by GMAC for every application received.

The Environmental Impact Statement by the United States Department of Agriculture on the release of insects carrying dominant lethal gene (RIDL), i.e. GM pink bollworm and GM fruit fly was also reviewed and taken into consideration as this RIDL technology is similar to that applied in the production of GM mosquitoes.

Through Risk Assessments, the USDA has proven that the release of GM organisms is safe to human and the environment when the release is conducted in a proper manner.

This is also in accordance with the Cartagena Protocol on Biosafety which advocates the precautionary principle approach. This principle is the very basis of our Malaysian Biosafety Act 2007.

During the 30 days of public consultation period which was made known through public announcements in the newspapers, it was stated that the public may refer to the fact sheet available in the Biosafety website for further information regarding the application and that they can contact the Department of Biosafety for further enquiries.

This includes requests for access to the application dossier. In addition, the ministry has also written to nine NGOs including CAP, SAM and TWN and all their concerns were taken into consideration by GMAC and NBB.

All the important information regarding the application and the basis for which the decision was made, is available on the Biosafety website in order to make it accessible to the public.

With regards to the area where the field trial will be conducted, the NBB has made it a requirement for the applicant to obtain prior consent from the local residents of the area.

Malaysia is not the first country to release these GM mosquitoes.

The Mosquito Research and Control Unit of the Cayman Islands have already conducted an open field release for purpose of suppression, where else Malaysia is only conducting a limited field trial release with the objectives of studying the flight distance and longevity of the male GM mosquitoes compared to the wild type.

Other countries such as Singapore, Thailand and India, to name a few are also looking into this technology and are at various stages of the research.

The information obtained through this limited field trial is necessary before any decision can be made to proceed with subsequent trials which may eventually lead to a suppression trial.

Should the applicant decide to proceed to the next stage, a fresh application need to be submitted to NBB which will undergo the whole rigorous process of obtaining the approval again.

This is clear evidence that the Ministry is very concerned in protecting human health, the environment and biological diversity in this country.

In an effort by the Government to control the acute situation of deaths arising from dengue and in preventing the further spread of dengue, every practical method available must be looked into and evaluated accordingly.

Should the use of this new GM mosquito technology be proven successful, it may be incorporated into the current Integrated Pest Management programme to target the remaining Aedes mosquitoes that cannot be managed by the existing control methods.

For more information, please contact the Biosafety Department at biosafety@nre.gov.my



                                  PART 3

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TITLE:   MOSQUITO TRIAL TO CUT DENGUE INFECTION GETS GO-AHEAD IN MALAYSIA

SOURCE:  Wellcome Trust, UK

AUTHOR:  Press Release

URL:     http://www.wellcome.ac.uk/News/2010/News/WTX063431.htm

DATE:    12.11.2010

SUMMARY: "The Malaysian government has granted approval to release genetically modified sterile mosquitoes into the wild in an open field trial. Supported by a Wellcome Trust Translation Award, Oxford-based biotechnology company Oxitec is hoping that its method of controlling the mosquito population will cut the spread of dengue infection."

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MOSQUITO TRIAL TO CUT DENGUE INFECTION GETS GO-AHEAD IN MALAYSIA

The Malaysian government has granted approval to release genetically modified sterile mosquitoes into the wild in an open field trial. Supported by a Wellcome Trust Translation Award, Oxford-based biotechnology company Oxitec is hoping that its method of controlling the mosquito population will cut the spread of dengue infection.

Dengue is a potentially fatal disease that is passed on from the bite of an infected female mosquito of the Aedes aegypti strain. Bednets are of little use, because this strain of mosquito also bites during the day. With more than 2.5 million people at risk of infection, methods to control the mosquito population and combat the spread of disease are urgently needed.

Oxitec has created a genetically modified strain of Aedes aegypti that is completely sterile and unable to reproduce. When the sterile males are released into the wild, they compete with other male mosquitoes to mate with females. But if a wild female mates with a sterile male, she will have no offspring that can survive to adulthood, and so the population of the next generation of mosquitoes is reduced.

Male mosquitoes do not bite and cannot spread disease, and will only mate with females of the same species. So the release of sterile male mosquitoes offers a safe alternative to insecticides. Because they only last for a generation, releasing the GM mosquitoes can't permanently alter the ecosystem.

Approval for the Malaysian trial follows the success of a smaller-scale trial conducted in the Cayman Islands earlier this year, which resulted in a significant reduction in the local mosquito population. See a video about the trial, conducted in collaboration with the Mosquito Research and Control Unit of Grand Cayman.

http://www.youtube.com/watch?v=_nY_AlWe5kM

Scientists released batches of the sterile male mosquitoes in cages, three times a week over a 16-hectare area between May and October of this year. By August, mosquito numbers in the trial area had dropped by 80 per cent compared with a neighbouring area where no sterile mosquitoes were released.

Oxitec's Chief Scientific Officer, Luke Alphey, explains: "The results from the Cayman trial show that our method works in principle, but with such a small area involved, it would have been difficult to detect a drop in dengue cases. Our estimates suggest that an 80 per cent reduction in mosquitoes should result in fewer dengue infections and we are hopeful that these effects will begin to be seen in the larger Malaysian trial."

Ted Bianco, Director of Technology Transfer at the Wellcome Trust, commented: "There is a general recognition that the threat to human health from dengue infection is growing. With no medication or vaccine currently available, our methods of limiting the spread of dengue have to centre on controlling the mosquito population. As innovative approaches to vector control emerge, it is important that they are evaluated rigorously, and in real world situations, so they can find their rightful place in the armamentarium of the public health agencies. It is for this reason that we are pleased to be supporting Oxitec's demonstration project and we look forward to the results of the Malaysian trial.?

Elsewhere, healthcare research company Roche has begun a clinical trial of a drug to treat dengue at the Oxford University Clinical Research Unit in Vietnam, with support from the Wellcome Trust. The drug was initially developed against the closely related hepatitis C virus but now researchers are looking to see whether it has any effects in patients infected with the dengue virus.

Dengue infection manifests itself with the sudden onset of fever, with associated headaches and severe muscle and joint pain that gives it the nicknames 'break-bone fever' or 'bonecrusher disease'.



                                  PART 4

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

TITLE:   GENETICALLY-MODIFIED MOZZIE TEST SHOWS PROMISE

SOURCE:  The Star, Malaysia

AUTHOR:  Tan Shiow Chin

URL:     http://thestar.com.my/news/story.asp?file=/2010/11/14/nation/7420537&sec=nation

DATE:    14.11.2010

SUMMARY: "The first-ever release of genetically-modified male Aedes aegypti mosquitoes into the wild in the Cayman Islands has shown promising results. [...] Malaysia's Institute for Medical Research is also planning to release the same GM A. aegypti strain in a field trial soon with Oxitec Ltd, a biotechnology company that provides a biological insect control solution using sterilisation techniques."

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GENETICALLY-MODIFIED MOZZIE TEST SHOWS PROMISE

PETALING JAYA: The first-ever release of genetically-modified (GM) male Aedes aegypti mosquitoes into the wild in the Cayman Islands has shown promising results.

Researchers from the country's Mosquito and Research Control Unit found that there was an 80% reduction of the A. aegypti population in the area where the GM mosquitoes were released from June to October this year.

Malaysia's Institute for Medical Research (IMR) is also planning to release the same GM A. aegypti strain in a field trial soon with Oxitec Ltd, a biotechnology company that provides a biological insect control solution using sterilisation techniques.

According to Oxitec chief science officer Dr Luke Alphey, the level of reduction in the Caymans is estimated to be high enough to help control the transmission of the dengue virus by female A. aegpyti mosquitoes.

The male mosquitoes released had been genetically modified so that any offspring produced would die at the pupal stage.

"We released, for a period of almost six months, about three million male mosquitoes into an area of about 16 hectares," he told reporters at the Science Media Centre in London on Thursday.

"We saw about 80% suppression of the target population. So, we believe that what we saw represents very strong control of the target mosquito population," said Dr Alphey, whose company owns the rights to the GM A. aegypti strain used.

He added that the researchers expect to get an even higher reduction level in a larger area â?? like a town, for example.

However, the trial could not provide data on the connection between the decrease in the A. aegpyti population and the number of dengue patients.

Dr Alphey said: "Dengue is somewhat unpredictable in time and space.

"In a trial of a short duration in a limited area, you wouldn't be able to say how many cases you would have got without intervention.

"So you wouldn't be able to say very easily that you have reduced that number."

He added, however, that this relationship should be more obvious in a larger trial where wider areas, like a town or city, are covered.

He also said that the Cayman Islands has a very low incidence of dengue cases, with only a few cases being reported in the past year over the whole island.

In Malaysia, trials to be conducted in Bentong, Pahang, and Alor Gajah, Malacca, are meant to test the limit of the GM mosquitoes' flying range and their ability to survive in the wild under local conditions.

Around 4,000-6,000 GM male mosquitoes, along with a similar number of normal male A. aegypti mosquitoes, are expected to be released in this trial, which has been approved by the National Biosafety Board.

IMR had previously carried out successful tests with the GM male mosquitoes in the lab, as well as in a simulated urban household of two to four people.



                                  PART 5

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TITLE:   OXFORD, IIM-A JOIN FORCES TO TAKE THE STING OUT OF MOSQUITOES

SOURCE:  The Times of India, India

AUTHOR:  Tamil News Network, India, by Chitra Unnithan

URL:     http://timesofindia.indiatimes.com/city/ahmedabad/Oxford-IIM-A-join-forces-to-take-the-sting-out-of-mosquitoes/articleshow/6922501.cms

DATE:    14.11.2010

SUMMARY: "A major breakthrough in the fight against dengue and chikungunya is in the offing, as Oxford University researchers, in association with IIM-Ahmedabad, are testing the potential of genetically modified mosquitoes to curb the killer diseases at a Chennai containment facility. [...] ?Early results are encouraging and if future open field trials are able to replicate this level of success, then we may well have a potentially major breakthrough in the fight against dengue and chikungunya,? said Oxitec's public health department head Seshadri Vasan."

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OXFORD, IIM-A JOIN FORCES TO TAKE THE STING OUT OF MOSQUITOES

AHMEDABAD: A major breakthrough in the fight against dengue and chikungunya is in the offing, as Oxford University researchers, in association with IIM-Ahmedabad, are testing the potential of genetically modified mosquitoes to curb the killer diseases at a Chennai containment facility.

Oxitec, part-owned Oxford biotechnology company, has conducted a preliminary trial on the mosquitoes in the British overseas territory of Cayman Islands. The demonstration trial with mosquito control and research unit at Chennai would probably be the first open field trial of any transgenic mosquito strain in the world.

''Early results are encouraging and if future open field trials are able to replicate this level of success, then we may well have a potentially major breakthrough in the fight against dengue and chikungunya,'' said Oxitec's public health department head Seshadri Vasan. Female mosquitoes belonging to Aedes aegypti or Aedes albopictus species are responsible for Dengue and chikungunya, which have afflicted over two million Indians  -  the highest in the world  -  in last six years. There is no specific treatment for either disease and experts say it may take another 10 years before an effective vaccine is available.

A multi-country study, led by IIM-A's Centre for Management of Health Services, has estimated the immediate cost of chikungunya and dengue to India at over $1 billion annually. Oxford's GM strain of Aedes aegypti mosquitoes (OX513A) are sterile as they carry two copies of a genetic element that can be switched off by providing tetracycline in the larval diet. When these sterile males mate with wild female mosquitoes, the offspring will inherit one copy of the genetic element.



                                  PART 6

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

TITLE:   GENETICALLY MODIFIED MOSQUITOES LINED UP TO TACKLE DENGUE FEVER

SOURCE:  The Guardian, UK

AUTHOR:  Ian Sample

URL:     http://www.guardian.co.uk/society/2010/nov/11/genetically-modified-mosquitoes-dengue-fever

DATE:    11.11.2010

SUMMARY: "Swarms of genetically modified mosquitoes could be released into the wild to combat dengue fever around the world. British scientists today said a small-scale trial of the strategy, which was carried out in the Cayman Islands, had cut mosquito numbers by 80% in six months."

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GENETICALLY MODIFIED MOSQUITOES LINED UP TO TACKLE DENGUE FEVER

Scientists use sterile males to mate with infected females in fight to curtail spread of disease that kills 25,000 people a year

Swarms of genetically modified mosquitoes could be released into the wild to combat dengue fever around the world.

British scientists today said a small-scale trial of the strategy, which was carried out in the Cayman Islands, had cut mosquito numbers by 80% in six months.

The trial - which used 3 million modified insects - was run with the Mosquito Research and Control Unit (MRCU), and has raised hopes that the disease may be curtailed in countries such as Brazil, Malaysia and Panama.

Dengue fever causes severe flu-like symptoms and can be lethal. It spreads through the bite of infected female aedes aegypti mosquitoes.

Researchers at the Oxford-based firm Oxitec modified male mosquitoes to carry a gene that means they can only survive if they get regular feeds of an antibiotic called tetracycline. Without the drug, the mosquitoes die within a few days.

When the mosquitoes are released into the wild, they mate with females but produce offspring that inherit the gene and so die almost immediately.

"One of the main advantages is that the males actively look for the females - that's what they are programmed to do," Luke Alphey, a scientist at Oxford University and co-founder of Oxitec, said.

"By giving them tetracycline in the lab, we can keep them alive and breed large numbers of them, but when we release the males into the environment and they mate with wild females, all the offspring inherit a copy of the gene that kills them if they don't get the antidote ... so they die."

The World Health Organisation estimates there are 50m cases of dengue fever a year, of which 25,000 are fatal. About 2.5 billion people - or two-fifths of the world's population - are at risk, mostly in Africa and south-east Asia.

There is no vaccine or treatment, and experts say new ways of controlling it are urgently needed because of a sharp rise in global infection rates in recent decades.

A report by the World Health Organisation last year estimates that in eight countries in the Americas and Asia, dengue fever causes illness, disability and deaths that cost at least $440m a year.

Angela Harris, of the Cayman MRCU, said she was encouraged by the trial, conducted from April to October. "This kind of technology really has a place for reducing dengue and having an impact on human health," she said.

"One of dengue's main problems is that there's no cure. So the only control you can really come by ... is killing the mosquitoes and making sure they're not there to transmit the virus in the first place."

Alphey said his firm was in talks with officials in several countries about further and larger trials.

The French drug firm Sanofi-Aventis is among companies seeking to develop dengue vaccines. It is testing a drug in late stage clinical trials - but it could be many years before a vaccine is on the market.




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