From Bio Journal - September 2007

Development of multi-disease resistant GM rice in Japan

NIAS in Tsukuba, Ibaraki Prefecture, is the research laboratory that has developed the most GM crops in Japan, and now has developed a GM rice that is tolerant to a number of diseases. The inserted gene is a transcribed factor called "WRKY45", which would excite a few hundred disease related genes only when a disease organism enters the rice. At the lab test, the GM rice showed tolerance to rice blast and white leaf blotch. NIAS will now conduct full-scale experiments on the new GM rice.

NIAS press release (Japanese)

Related article in English

Codex GMO meeting in Japan in September

The 7th meeting of the Codex Intergovernmental Task Force on Biotechnology (TFBT) will be held at Makuhari, Chiba Prefecture between September 24 and September 28, 2007. It will be the 3rd year of the 2nd round, and this year's discussion will be the crucial one since the task force will end next year. The task force will discuss three subject this year. 1) Formulation of a Draft Guideline for the Conduct of Safety Assessment of Foods Derived from rDNA Animals. The focal point will be whether to allow antibiotic resistance marker genes to be used or not. 2) To begin work on an annex for the rDNA plant document on how to carry out safety assessment of plants modified for nutritional or health benefits. The focal point will be how strict the safety assessment can be without using the controversial "substantially equivalent" measure. 3) How to deal with cases of low level presence of unauthorized rDNA plant materials (when foods are accidentally contaminated by unapproved GMOs). The focal point will be how hard the US government will push to demand tolerance of the presence of "unapproved GMOs".

TBFT Agenda (pdf)

MHLW English Codex site

4th generation somatic cell pig born

A research team at Meiji University under Prof. NAGASHIMA Hiroshi announced on 6 August 2007 that it had produced a somatic cell cloned pig, and had then repeated the cloning process by taking further somatic cells from the next generation up to the fourth generation. The somatic cells used in each case were salivary gland cells.

Further, a joint research team from the same university and the venture corporation Bios Inc's medical research lab (Hiratsuka City, Kanagawa Prefecture) have produced a clone pig from a GM pig into which the gene that causes human diabetes had been introduced. The object of all this is the establishment of technology for the mass production of "pharm" animals - animals that are genetically engineered to produce pharmaceuticals for human medical needs.
(Yomiuri Shinbun 2007/08/07)

US gene therapy patient dies from side-effects

The US Food and Drug Administration (FDA) announced on 26 July 2007 that a patient had died from side-effects after administration of an experimental drug during gene therapy for arthritis being conducted by the venture corporation Targeted Genetics Corp., and that therefore the clinical trials had been suspended.

The vector (gene carrier) used was the adeno-associated virus (AAV). A gene associated with the Tumor Necrosis Factor (TNF), which prevents advance of inflammation, was introduced into the vector and this was administered to the patient's joints twice when unpredictably severe side-effects occurred. The FDA says it will carry out a safety check on all remaining 28 gene therapy trials using the AAV vector in the USA. (Mainichi Shinbun 28 July 2007)

At present in Japan the only gene therapy trial using the AAV vector is the Parkinson's disease gene therapy trial conducted by the Jichi Medical University, which began on 7 May 2007. It is possible that the MHLW will ask Jichi University to take measures to suspend the trial temporarily on the basis of this side-effect incident in the USA. It is inevitable that this side-effect incident will have a very serious effect on gene therapy as a whole since the AAV is considered to be relatively safe virus.

Gene therapy for AIDS begins with monkeys

Takara Bio Inc. cell and gene therapy center has been developing a new vector (gene carrier) for the gene therapy of AIDS. The gene used for the therapy is ribonuclease (RNase) and this has been inserted in a retrovirus. Because the HIV AIDS virus has a weak infectious capability, monkeys are not infected by it, and so the virus similar to HIV which only monkeys are infected by, SIV (simian immunodeficiency virus), has been joined with the HIV virus to create a chimera virus, SHIV, to carry out experiments on monkey cells. No multiplication of the SHIV was seen in the cells used to carry out the gene therapy, and now experiments will be carried out on live monkeys. (Takara Bio Press Release, 17 July 2007)

SHIV is a virus that will infect both humans and monkeys and so there is a danger that this could spread in the environment to humans from monkeys as a medium.

Decision for 5-year extension of order-made medicine project

After only two discussions the MEXT "Working Group on Research Strategy for the Promotion of the Realization of Order-Made Medicine" has finalized a draft report for a five-year extension of the project. (See BJ August 2007) While maintaining the huge data bank, which has amassed 300,000 blood samples and associated treatment data, the project will now aim for more complete data on personal lifestyle habits, practices and so on.

Basic guidelines for fertilized abnormal ova use in human clone embryo research

The MEXT working group held a meeting on 31 July 2007, at which serious discussions were begun on the approval of the use of abnormal fertilized ova in human clone embryo research. (See BJ August 2007) At present, the abnormal ova to be covered will be the triploid ova from ectosomatic fertilization during fertility treatments. These are usually discarded, but it is now agreed as a basic guideline that these would be donated. Next on the agenda is to formulate the requirements for informed consent.

Concerning the actual handling of triploid ova in fertility treatments, Keio University Medical School Professor YOSHIMURA Yasunori stated, "Some are discarded, but almost all of the ova are being used for research and so on. If asked whether it was OK to use them for research or not, there's really no one who would answer 'no'." In a contrasting and cautious opinion, Kyoto University Graduate School Professor IDA Ryuichi stated, "You can't necessarily say that just because they are used for reproduction assistance medicine then it's OK to use them for human clone research. The allowability for (use in) reproduction assistance medicine, which is for the birth of human life, is on a different level."

Research project including genetically engineered human ES cells approved

At the MEXT specialist panel meeting held on 26 July 2007, a new project using human ES cells proposed by Kyushu University Medical Institute of Bioregulation was approved. (See BJ May 2007) The research project will use human ES cells which have been previously produced. According to the proposal, human ES cells will be allowed to differentiate to produce blood cells for transplantation, and genetic engineering techniques will be use to try to increase the efficiency of differentiation.

The clinical efficacy of genetic therapy is being doubted, but the techniques of introduction of genes into viruses and so on by the use of vectors (gene carriers) developed by gene therapy has found use in unpredicted areas. So far, out of all the proposals for human ES cell use approved by MEXT, there have been three cases of proposals including the use of genetic engineering, and this proposal by Kyushu University will be the fourth such case. It is now expected that the introduction of foreign genes into human ES cells for the purposes of raising the efficiency of differentiation or for immunosuppression will become more and more active in the near future.

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