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VATIS Update Biotechnology . Mar-Apr 2003

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ISSN: 0971-5622

VATIS Update Biotechnology is published 4 times a year to keep the readers up to date of most of the relevant and latest technological developments and events in the field of Biotechnology. The Update is tailored to policy-makers, industries and technology transfer intermediaries.

Co-publisher: Biotech Consortium India Ltd
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Contents

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IN THE NEWS

International stem cell project

In the United Kingdom, discussions have been initiated by the Medical Research Council to set up an international consortium for research on stem cells. The consortium would coordinate existing resources, such as human stem cell lines, in order to avoid duplication of research. Representatives of agencies that already fund such studies in the United States, Canada, Australia, Finland, Sweden, Singapore and Israel participated in the talks. Also, the consortium would identify strengths of each member country and pool them. For example, the United Kingdom has the most favourable stem cell legislation while researchers in the United States have expertise on the way stem cells specialize. Although the project is not yet formalized, this meeting led to the creation of two expert working groups, one will focus on quality requirements to undertake stem cell research while the second would outline ethical rules in each country. 


Nature Biotechnology, Vol. 21, March 2003

Asian Bank approves funds for research on iron-rich rice

The Asian Development Bank (ADB) has approved additional funding of US$905,000 for research on cultivation of iron-rich rice to help reduce anaemia among Asias poor. The funds, provided from the Poverty Reduction Cooperation Fund of the United Kingdom government, augment a technical assistance (TA) grant of US$1.3 million approved by ADB in October 2002. The TA aims at increasing the amount of iron and other micronutrients in rice through bio-fortification. Half of Asian women and pre-schoolers, and 60 per cent of pregnant women are anaemic, most of them from poor families. According to Mr. Bradford Philips, Director of ADBs Natural Resources and Social Sectors Division, this project provides a cost-effective opportunity to reduce anaemia and iron deficiency among one billion at-risk people in Asia over the next decade.


The project will also enable national agriculture research systems in Bangladesh, China, Indonesia, the Philippines and Viet Nam to adapt iron-dense rice to local growing conditions. The new funds will be used to investigate breeding of Vitamin A-rich -carotene to raise the nutrition potential of rice. The project is conducting a feeding trial of rural pre-school children in Bangladesh using iron-rich rice to improve health and cognitive development. It is also assessing the potential of wheat for bio-fortification and aims to promote strategic partnerships that link agricultural research with national food policy formulation and strategies for rice and wheat bio-fortification in all major rice- and wheat-producing nations. 


India Grains, February 2003

Agreement signed to boost Singaporea genomic programme

The Genomic Institute of Singapore (GIS) and the Agency of Science, Technology and Research have signed an agreement with Genomic Collaborative Inc. (GCI) of the United States to build a DNA and tissue sample repository for the Government of Singapore in an effort to advance the countrys genomic initiative. The repository, known as the Singapore Tissue Network, would be linked with an extensive clinical phenotypic database from the National Disease Registry Office. Under the guidance of the Ministry of Health in Singapore for policies, the network will provide infrastructure for nationwide collection, processing, quality control, archiving and distribution of high-quality, annotated tissue and DNA samples collected under strict ethical standards and procedures in support of biomedical research needs of Singapore. GCI will provide services, including advising on staff and physician recruitment, sample collection, tracking, processing, storage and retrieval. In addition, it will offer advice on data collection, database generation, as well as software systems management, integration and operation. 


Genetic Engineering News, Vol. 23, No. 1, 1 January 2003

GM foods in EU

The European Union (EU) has withdrawn a 4-year ban on foods that incorporate genetically modified organisms (GMOs), following the drafting of a new labelling directive. The European Commission will put in place a mechanism to make the new system work the European Network of GMO Laboratories (ENGL). The new rules will require a GMO label on any food containing more than 0.9 per cent of GMO material, a threshold designed to allow for some accidental contamination. The Joint Research Councils main lab in Ispra, Italy, will coordinate the ENGL network of more than 45 institutes in 15 EU member states and 10 countries that are expected to join in 2004. These labs will randomly test foodstuff to ensure that they are GMO-free or that they contain only approved GMO material.


In future, any food company that wishes to market a new GMO will have to submit reference material and a specific testing method to the Ispra ENGL lab. ENGL will validate the test and, if approved, it will be registered as an international standard. All ENGL labs will then use the test in their countries. The idea behind the new legislation is to allow consumers to choose GMO-free food if they wish, while allowing biotech companies to market their wares. 


Science, 13 December 2002

Clinical trials with stem cells

Reliance Life Sciences, India, has announced the nations first-ever clinical trials based on embryonic stem cell research. Stem cells are special as they can be stimulated to develop into any organ, under proper conditions. Reliance had earlier developed seven lines of embryonic stem cells in 2001 and the National Institute of Health in the United States, had cleared them for funding. The clinical trials, in which Reliances stem cells will be injected into the heart to develop into new muscles to replace dead ones, are likely to commence by the year-end. 


Businessworld, 3 February 2003

Smuggling of blood samples

The Indian Council of Medical Research (ICMR) is probing the methods employed by a team of foreign scientists who collected blood samples of tribals from Andhra Pradesh for a controversial genetic study without the knowledge or permission of ICMR. Scientists and tribal welfare workers had expressed anguish over the smuggling of blood samples from the state. A paper published in an international science journal hints at collusion between a university in the United Kingdom and a Hyderabad-based scientific institution where blood samples of various tribal populations of the country are collected without permission.


Mr. P. Sivarama Krishna, Director of a non-governmental organization called Shakti, who works with Chenchu tribes, said two months ago a lady from a university in Kolkata had collected blood samples of Chenchu tribes. The lady is reported to have said that she had obtained permission from ICMR. Mr. Krishna opines that this should have been investigated. According to some scientists the DNA of these tribals is among the best in the world as they are immune to a number of diseases like malaria and influenza. The setting up of a tourist zone where this tribal population dwells, had made it all the more easy for anybody to have access to the area. According to some sources, the samples could have been collected at the behest of the World Health Organization for a study on AIDS. It could also have been sponsored by one of the multinational companies. 


Chronicle Pharmabiz, 27 March 2003

India set to embrace GM rice

Indias apex body of agricultural scientists has given the green signal for widespread introduction of genetically modified (GM) varieties of rice, lifting the gloom in the biotech industry cast by government indecision over GM mustard. A spokesperson for the New Delhi-based National Academy of Agricultural Sciences (NAAS) said that for the additional 50 per cent more rice needed by the year 2030, rice varieties with higher yield and greater yield stability have to be introduced. NAAS, the largest body of professional agricultural researchers in India, has endorsed development of rice varieties tolerant to drought, submergence and salinity, and rich in micronutrients. Transgenes encoding products like Bt (already introduced in cotton varieties released last year) can also be put in rice for pest resistance.


Switzerland-based Syngenta, which has a major rice programme in India, is working in collaboration with as many as 35 institutions, including the Pant University of Agriculture and Technology at Pantnagar and the Konkan Agricultural University in Dapoli. NAAS full support for GM rice came after a workshop dispelled the fears of non-governmental organizations (NGOs) that releasing transgenic varieties in a centre of origin of rice would risk contaminating the land races, as was the case with maize in Mexico. The NAAS recommendations are a shot in the arm for biotech research in the country and transgenic varieties of rice are available for trials. According to NAAS, the lack of a scientifically sound regulatory review process is one critical factor that might limit realization of the numerous proven and potential benefits of GM rice. 


Nature Biotechnology, Vol. 21, February 2003

Indian DNA-AIDS vaccine to hit the market in five years

According to Dr. N. K. Ganguly, Director General of the Indian Council of Medical Research (ICMR), an indigenously developed DNA-AIDS vaccine is expected to hit the market in another five years. The vaccine would go into its first phase trial by October this year after a six-month study phase. Developed jointly by ICMR, National AIDS Control Organization (NACO) and the Union Ministry of Health, the vaccine would have six Indian genetic sub-types. The vaccine would not be very costly as it is developed using public funds.


Another vaccine against cervical cancer is in a pre-trial stage, but is facing ethical issues at present. According to Dr. Ganguly, the vaccine had to be used on girls in the age group of 15-18 years. However, guidelines forbid them from conducting examinations on unmarried women. Dr. Ganguly said that population genetic projects concerning genotyping the Indian population would come up with comprehensive data in another four years. The project is expected to provide complete data on which groups of people are prone to which types of diseases in the country. ICMR has already set up guidelines for genetically modified foods, while the ones on stem cell research are being debated. 

Chemical Weekly, 18 February 2003

Incubation-cum-biotech park

The Department of Biotechnology (DBT) of India, in association with the Uttar Pradesh (UP) state government, is developing an Incubation-cum-Biotechnology Park at Lucknow. This is the second phase of a plan to develop Lucknow as a Biocity. In the first phase, a bioinformatics centre was established at the Industrial Toxicology Research Centre (ITRC). For the two-year US$2.22 million project, US$1 million has already been released and land provided by the UP state government. A registered society will be formed to manage the park. The plan is to develop the park on par with international models and in the initial stage an incubation centre, bioinformatics centre and business centre are planned. The incubation centre would act as a nodal point to facilitate research and development in the emerging areas of biotechnology and all major instrumentation would be provided at the incubation centre.


Bharat Biotech and Crest Biotech will be the first companies to set up production facilities in the upcoming Biotech Park, while Ranbaxy Laboratories, Panacea Biotech and Cadila Pharmaceuticals will follow suit. Industries that have already developed technology and need to refine, validate and upscale can also hire facilities at the incubation centre. The biotechnology department of IIT-Kanpur is also in the process of setting up a bioinformatics incubation centre on its campus, which would be linked to the park at a later stage. 


Express Pharma Pulse, 9 January 2003

Canada rejects oncomouse

Ruling on a patent application from mid-1985, the Canadian Supreme Court has stated that genetically modified oncomouse and other higher life forms may not be patented. According to the Court, the current Act does not clearly indicate that the higher life forms are patentable; clear and unequivocal legislation is required for higher life forms to be patentable. This decision upholds an earlier ruling by the Canadian Commissioner of Patents not to allow Harvard University, the United States, a patent for its genetically modified mouse line carrying an oncogene that makes these animals prone to develop cancer and thus useful for tests. Representatives of the Canadian biotechnology industry are unhappy with the ruling, saying it undermines the patent process. The United States, Australia, Japan and the European Community have all granted oncomouse patents.


Nature Biotechnology, Vol. 21, January 2003

MARKET NEWS

Marketing approvals for a dozen biotech products

The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests (MoEF), India, has approved 12 biotech products for marketing in the country. While 11 of them are for human use, one is a veterinary vaccine for foot-and-mouth disease to be manufactured and marketed by Brilliant Industries, Hyderabad. GEAC has also given permission to Wockhardt Ltd. to use 150 l fermentation volume for lab-scale r-human insulin process development and permitted Biocon India Ltd. for large-scale process optimization studies of r-human insulin (for R&D purpose).


Five of the products that are to enter the market following GEAC approval are to be imported from China. These include rh-G-CSF from Shandong Geneleute Bio Pharmaceutical Co. Ltd., Interferon alpha 2b from Anhui Anke Biotech Co. Ltd., rhu EPO from Beijing Four Rings Bio Engineering Product Factory, filgrastim from Xiamen Amoytop Biotech Co. Ltd. and hurG-CSF from Hangzhou Jiuyuan Engg. Co. Ltd. Indian companies that are to import and market the above products are Kee Pharma Ltd., Ranbaxy Laboratories Ltd. Glenmark Laboratories Pvt. Ltd. and Cadila Pharmaceuticals Ltd. The other products are human insulin analogue injection formulations (Novo Nordisk, Denmark), erythropoietin (Laboratorio Pablo Cascra SRL, Argentina), bulk insulin and its formulations (Novo Nordisk, Denmark), r-human insulin (Bioton Co. Ltd., Poland) and Pegasys or peginterferon alpha 2a (Switzerland). (Chronicle Pharmabiz, 27 March 2003)

HCV Card Test and ELISA kits

Bhat Biotech, a diagnostic kit and a recombinant DNA technology major based in Karnataka, India, has received the manufacturing license for HCV Card Test and HCV ELISA. The products will be launched in the market soon. The HCV Card Test is a fourth-generation test, which has the advantage of storing at room temperature and is easy to use like a pregnancy test kit. HCV ELISA is similar to HIV ELISA used to detect the presence of HCV antibodies. 


Chronicle Pharmabiz, 16 January 2003

Biocon-Centre for Molecular Immunology in pact for new drug

Biocon India Group has entered into joint technology development with the Centre for Molecular Immunology, a monoclonal antibody and cell culture technology major based in Cuba, for research and production of a novel drug to treat head and neck cancer. The joint venture, which is a 51:49 partnership, will develop an anti-Epidermal Growth Factor human monoclonal antibody. While the total investment is around US$55.55 million, the Cuban technology venture alone requires a capital of US$16.6 million. It is estimated that the massive technology absorption would take a minimum of two years time to be ready for approval from the Drugs Control of India and would undergo Phase-I, II and III trials through Clinigene International, which is part of the Biocon Group. 


Chronicle Pharmabiz, 6 March 2003

Biocon-Shantha Biotech to begin trials of human insulin

In India, Biocon-Shanta Biotech plans to begin clinical trials of its human insulin. The company intends to launch the product during October 2003. The insulin unit of the company would be the largest manufacturing facility in the country, with an annual capacity of 18 million doses of 40 ml strength and three million doses of the 100 ml strength during the first year. Biocon-Shanta Biotech is a 50:50 joint venture between Bangalore-based Biocon India and Hyderabad-based Shanta Biotech. The joint venture has a total investment of US$5.55 million. The bulk of insulin production of this venture will be carried out at Biocons facility while the packaging will be undertaken by Shanta Biotech. 


Chronicle Pharmabiz, 16 January 2003

Commercialization of GM mustard delayed in India

Under pressure from environmental lobbyists, the Indian government has delayed approval for what would have been the countrys first commercialized genetically modified (GM) food crop, in an about-face that members of the agbiotechnology industry call scientifically unjustified. The Genetic Engineering Approval Committee (GEAC) was expected to approve a strain of GM mustard developed by ProAgro Seeds of New Delhi on 7 November, but deferred its decision and then cancelled another meeting scheduled for 10 December. Opponents of the pending approval, including the Indian Council of Agricultural Research (ICAR), want more field trials since the GM mustard was tested for biosafety at private labs. However, ProAgro clarified that it has conducted 69 field trials that employed ICARs own protocol and the crop was tested by government-accredited labs. 


Nature Biotechnology, Vol. 21, January 2003

New cancer therapy product

A three-year US$4.5 million research agreement for identifying a targeted cancer therapy product candidate, that has been designed to treat primary tumours as well as metastasized tumours, has been signed between GenVec, the United States and Fuso Pharmaceuticals, Japan. According to the pact, GenVec gets worldwide rights, excluding Japan, for developing and commercializing product candidates arising from the collaboration while Fuso retains development and commercialization rights in Japan, and an option for product commercialization in the Republic of Korea and Taiwan-China. The targeted cancer therapy is expected to incorporate the gene for tumour necrosis factor alpha, although GenVecs lead anti-cancer candidate. TNFerade, which is currently in phase II trials for pancreatic and esophageal cancers, is not subject to the collaboration with Fuso. 


Genetic Engineering News, Vol. 23, No. 1, 1 January 2003

Animal models to test therapeutic activity of compounds

The Chinese National Centre for Drug Screening (CNCDS) in China and Thuris, the United States, have joined hands to evaluate the therapeutic activity of CNCDS compounds with Thuris RapidAging animal models. Thuris will test kinase, protease and inflammatory inhibitors selected from the chemical libraries of CNCDS.


Rapid Aging is a system for testing potential anti-ageing and Alzheimers disease drugs directly against primary pathologies, including neurofibrillary tangles, amyloid toxicity, inflammatory reactions, microglial activations and others. Thuris will create the pathologies within six days, in intact slices of living brain tissues. The technologies enable rapid, precision testing of drug candidates against any or all of these targets. 

Genetic Engineering News, Vol. 23, No. 1, 1 January 2003

DNA-based genetic testing

In India, Reliance Life Sciences (RLS) has teamed up with a major thyroid testing laboratory, Thyrocare Technologies Ltd., to offer DNA technology-based genetic testing across the country. These tests are employed to diagnose prenatal and post-natal genetic mutations and disorders as well as chromosomal abnormalities. It could also be used for diagnosing specific numerical and structural chromosomal anomalies (like Downs syndrome and Edward syndrome) for rapid detection and quantitative analysis in the area of oncology and B-thalassemia. As part of the arrangement, Thyrocare offers its network of franchisees in over 400 cities reaching 50,000 medical consultants and 12,000 laboratories to procure samples and provide air-cargo logistics for the menu of tests offered by RLS, which will provide testing services and make the reports of the tests available through an integrated web-based reporting system.


Chemical Weekly, 11 February 2003

Demand for biologics to reach US$55 billion in 2006

A new report released by Freedonia Group Inc., the United States-based industrial market research firm, indicates that the demand for biologics in the country will increase annually by over 11 per cent, reaching US$55 billion in 2006. New product introductions will lead growth as advances in recombinant DNA and monoclonal antibodies enable researchers develop better medicines for cancer, autoimmune diseases, infectious and viral disorders, and other major health conditions. The report, Bilogics, presents these and other trends.


The combined demand for conventional biologics will increase by 6.4 per cent annually through 2006. However, competition from bioengineered products will inhibit faster growth, especially for cellular components and plasma fractions. Recombinant proteins will evolve into the top-selling class of biologics, with annual demand rising over 13 per cent to surpass US$24 billion in 2006. Second-generation erythropoietin, lower dosing human insulin analogues, anti-arthritic beta interferons, albumin-free anti-haemophilic factors and longer-circulating colony stimulating factors will drive growth.


Monoclonal antibodies will amass the strongest demand gains among all biologics, spurred by commercialization of new cancer, asthma and anti-inflammatory compounds. Combined demand for these compounds will reach US$12.8 billion in 2006, up almost 16 per cent annually from 2001. In addition to therapy, continuing widespread use in immunodiagnostics and viral disease research will contribute favourably to growth. In terms of application areas for biologics cancer treatment is a growing area, owing to the ineffectiveness of many existing therapies and increasing penetration of new recombinant proteins, monoclonal antibodies and preventive vaccines against several common malignancies. Asthma, hepatitis, multiple sclerosis and rheumatoid arthritis will comprise other application areas based on the improved therapeutic profiles offered by advanced biologics.


Chemical Weekly, 11 February 2003

Collaboration to develop human monoclonal antibodies

A license agreement between Human Genome Sciences, the United States, and the pharmaceutical division of Kirin Brewery Co., Japan, will see that both companies collaborate in the development and commercialization of agonistic human monoclonal antibodies to TRAIL Recptor-2. The companies will work together to identify and optimize the best aspirant to enter clinical development. Kirin will develop and commercialize any resulting drug in Japan and Asia-Australia while Human Genome Sciences will develop and commercialize in North America, Europe and the rest of the world. 


Genetic Engineering News, Vol. 23, No. 1, 1 January 2003

INVENTIONS/NEW PRODUCTS

Patent for Red/ET recombination

Gene Bridges GmbH, Germany, has obtained an additional United States patent for Red/ET Recombination, a breakthrough technology in DNA engineering with regard to manipulation, cloning and modification of DNA. This patent includes DNA cloning processes using lambda-mediated homologous recombination. The company has exclusive rights to this platform technology.


Red/ET Recombination is an innovative technology that allows for cloning and precise modification of DNA molecules, regardless of composition and size. Gene Bridges is a DNA engineering specialist company and offers DNA engineering courses on Red/ET Recombination. It is also commercializing its exclusive rights to the patented Red/ET Recombination technology throughout the world by licensing, DNA engineering services, kits and reagents.


Chronicle Pharmabiz, 20 February 2003

New DNA chip detects and identifies pathogens

Researchers at the University of Rochester, the United States, have created a new technique that can easily detect pathogens, whether from natural diseases or biological weapons. This process is based on a breakthrough technique that can sense harmful DNA and immediately alert a doctor or scientist. Researchers employed custom-designed loops of DNA that emit coloured light in the presence of a specific creatures DNA. The loop-laden chip could be used to detect anything, from a virus or bacterium to the specific DNA of a plant/human.


The new chip is remarkable in that it eliminates many of the time-consuming steps normally taken in identifying an organism by its DNA. Traditionally, workers in a laboratory have to make thousands of copies of a piece of DNA they want to test, followed by a complex series of steps in order to attach a special molecule to the DNA, which will act as a fluorescent beacon, making the DNA strand easy to detect. These beacon-outfitted pieces are then mixed with control DNA sequences to see if any match. Matching sequences would adhere to one another and their presence is known through the beacon. In the new process, a scientist might only have to place a drop of the solution in question on to a small chip or card and watch for a change of colour to indicate whether specific DNA is present. The chips are sensitive enough to eliminate copying, as are complex beacon attachments, and the chips can be easily manufactured.


A chip using the new method would be constructed akin to a field of wilted sunflowers customized sequences of DNA that are bent like hairpins, with one end planted into a layer of metal and the other end hanging down alongside it. This dangling end contains a flourophore molecule, which shines brightly when properly lighted. Unfolding of the chips detector DNA strands occurs when new DNA with a precise sequence is dripped on to the chip. The chips DNA is designed to prefer to be bonded with a specific DNA sequence, such as a sequence unique to anthrax, than to remain folded over on itself. The new DNA bonds along the length of many of the chips DNA and the two form a sort of rigid stem that lifts the beacon. The all-important beacon is pre-attached to the detector strand of DNA, rather than being attached to each and every strand of DNA being scrutinized. 


LifeSciencesWorld eNewsletter, 17 April 2003

Storing information on DNA

In the United States, Prof. Richard Kiehl et al. at the University of Minnesota have used the selective stickiness of DNA to construct a scaffolding for closely spaced nanoparticles that could exchange information on a scale of 10 angstroms (an angstrom is one/10 billionth of a metre). This technique facilitates assembly of components on a much smaller scale and with much greater precision than feasible with current manufacturing techniques.


In a standard silicon-based chip, information processing is limited by the distance between units that store and share information. With DNA crystal scaffolds incorporating nanoparticles spaced 20 angstroms apart, a chip could hold 10 trillion bits per cm2 100 times as much information as in the 64 Gigabit D-RAM memory projected for 2010. Eventually, a chip fabricated using DNA crystals and nanoparticles would be available in such applications as real-time image processing. Nanocomponents could be clustered in pixel-like cells that would process information internally and also by talking to other cells. The team devised a DNA scaffolding for arrays of nanoparticles of gold. Information could be stored as an electrical charge on certain nanoparticles; the presence or absence of charge would constitute one bit of information. Alternatively, nanoparticles could be magnetic and the magnetic states would be read as information. 


Chemical Weekly, 25 February 2003

Novel ethnic DNA chip

In the Republic of Korea, the Centre for Functional Analysis of the Human Genome has produced a DNA chip specialized for genes derived from stomach tissues of Koreans. The chip includes 14,000 genes derived both from stomach cancer cells and normal tissue, and is the first DNA chip specialized for a specific ethnic group. The chips will be available for researchers soon.


The genome centre had previously identified 670 genes related to stomach and liver cancer, relying on commercially available chips with genetic data derived from other ethnic groups. Stomach cancer is more common in Japan and eastern Asia than seen in the United States and Europe. The rate of stomach cancer among people of Korean or Japanese ethnicity in the United States are 3-5 times higher than that for Caucasians in the United States, native Americans or Filipinos. 


Website: www.genomeweb.com 

GENOMICS

mRNA repair process may rectify defective genes

A team of investigators led by Dr. Alfred L. George Jr. at Vanderbilt University Medical Centre, the United States, has successfully repaired a flawed gene and demonstrated that the resulting protein product is functional. This breakthrough is a crucial step in showing that a particular method of gene repair is possible, raising hopes about moving forward with this type of gene therapy strategy.


Gene therapy is a term that describes different modes of gene-based treatments The RNA repair method studied uses molecules called ribozymes repair machines that can be engineered to correct a defect in a selected messenger RNA. Myotonia congenita disease serves as an excellent model for testing ribozymes as potential gene therapeutics. 


Express Pharma Pulse, 2 January 2003

New approach to prevent HIV from entering human cells

In the United States, a new gene therapy approach that prevents the AIDS virus from entering human cells has been developed at the University of California-Los Angeles (UCLA) and California Institute of Technology (Caltech). The technique offers a potential way to treat HIV patients and could apply to any disease caused by a gene malfunction, including cancer. The research team, led by Dr. Irvin S. Y. Chen, created an application for a genetic technology called small interfering RNA (siRNA). The synthetically designed siRNAs act as a catalyst to reduce the expression of specific genes and slow the progression of disease.


Though synthetic siRNAs are powerful tools, the method to insert them into the immune system in stable form was not readily available. Dr. Chen collaborated with Dr. David Baltimore of Caltech and their team constructed an innovative carrier from a disarmed version of the AIDS virus to deliver siRNA into human cells. The goal was to genetically erase a receptor, a protein on the surface of the cell, that HIV requires in order to spread. HIV needs two receptors. One is CD4, which is found on the infection-fighting T-cell essential for proper immune function. The other receptor, called CCR5, also plays a role in immune function but is not essential for normal body function. In fact, roughly 1 per cent of the white population is born without it. Studies have shown that these people are protected from HIV infection. 


Express Pharma Pulse, 2 January 2003

What makes us tick? 

Researchers at Purdue University in the United States report that all activities in an organism is governed by a single protein. Mr. D. James and Ms. Dorothy Morr uncovered that if the protein is altered, an organisms body will experience days of different length ranging from 22 to 42 hours. Ms. Morr found that cells increase in size at periodic intervals they enlarge themselves for 12 minutes and then rest for 12 minutes. This complex interaction of proteins is the basis for many activities within cells. Therefore, Ms. Morr theorized that some undiscovered proteins were responsible for the 24 minute cycle of cells.


In a recent breakthrough it was found that a single cylinder-shaped protein regulates the cell enlargement cycle. In order to confirm that the protein is responsible for all activities set by the biological clock, the gene which produced the protein was isolated. This gene was cloned and altered in ways that produced different period lengths and the team was able to produce clocks with cycles of 22 and 42 minutes. The day that the cell experienced was precisely 60 times the period length of the proteins cycle. This discovery could be used for minimizing jet lags or determine when best to administer cancer drugs. 


Down to Earth, 15 February 2003

FoxM1B gene critical in tissue healing

The FoxM1B gene found on human chromosome number 12 has been shown to be critical for tissues to heal and replenish themselves by a team at the University of Illinois in the United States. If the gene is defective or just tired out (as in old age and rare genetic disorders causing premature ageing), DNA cannot duplicate itself and as such cells cannot divide and multiply the way they normally do, resulting in a flood of activity in genes associated with ageing. Studies have shown that Fox family genes,found in animals, from insects up to mammals, are involved in the entire life cycle of a cell its proliferation, maturation and death.


A key finding discovered was how FoxM1B gene in mice affects the growth of liver after a portion of the organ is removed. Experiments have shown that the liver grows back at a rate typical of young mice. The new study was to understand how FoxM1B directs the busy molecular traffic inside a cell to make it proliferate. In a feat of genetic engineering, the team created mice with liver cells lacking the FoxM1B gene. Rates of regeneration were measured in these mice and in mice whose FoxM1B gene was intact. Without FoxM1B, regeneration was slow. FoxM1B controls both the basic steps essential for cell division doubling of DNA and then separation of the duplicated DNA into two new daughter cells. The DNA failed to duplicate as a result of a pile-up of a protein called p21Cip1. According to the investigation, FoxM1B probably unleashes the enzyme that normally digests this protein to prevent it from building up in the cell. When the p21Cip1 protein accumulates, it sets in motion a series of molecular events that prevent DNA from doubling and gives a green light to genes linked with diseases of old age. 


Express Pharma Pulse, 2 January 2003

Blood vessel gene could lead to complex birth defect

According to a study, a gene known for its ability to form blood vessels has been found to be a key player in a chromosomal abnormality that causes potentially devastating birth defects in the heart and throughout the body. A group of collaborators from across the globe reports that abnormalities in vascular endothelial growth factor, or VEGF, is a cause of DiGeorge syndrome. This syndrome can cause a wide range of heart defects, many of which are vascular in nature, as well as problems with the thymus and parathyroid gland, craniofacial abnormalities and mental retardation.


Among the follow-up steps, one would be to find why these VEGF defects occur with an ultimate goal of trying to prevent them. Researchers found the target downstream of human chromosome 22, which is known to be deleted in 60-70 per cent of people with DiGeorge syndrome. Deletion of chromosome 22 removes a group of 24 genes as well, many of which are transcription genes known to control downstream targets. According to Dr. Conway, although the targets remain largely unknown, it is believed that these 24 genes control hundreds, even thousands, of downstream genes, which helps explain the complexity of the syndrome that can result when the chromosome is deleted. One of those 24 genes is Tbx1, which is widely considered the primary gene involved in DiGeorge syndrome. 


Express Pharma Pulse, 13 February 2003

Genetic tinkering turns one species into another

By swapping chunks of DNA on a yeasts genome, researchers have turned one species into another. This genetic tinkering has helped researchers learn how species form and has shown that it is possible to instantly undo, and thus illuminate, thousands of years of evolutionary change. The research team led by Mr. Stephen Oliver of the University of Manchester, the United Kingdom, engineered the chromosomes of brewers yeast Saccharomyces cerevisiae to make it indistinguishable from a related species, S. mikatae, by reversing a process by which one species splits into two.


The hallmark of different species is their inability to mate and reproduce. One way this reproductive isolation is thought to occur is when fragments of DNA accidentally swap between an individuals chromosomes; this chromosomal translocation makes them incapable of reproducing with others of the same species. In yeast, if a mutated individual mates with a normal one, then half the spores formed will be missing parts of the genome, and will be less successful in reproducing than their parents. This implies that the mutated individual has been somewhat isolated, in a reproductive sense, setting it on the path to becoming a new species. S. cerevisiae and S. mikatae are thought to have diverged in this manner. The genome sequences are very similar, but parts of their chromosomes are swapped in one species relative to the other.


Dr. Olivers team is now using the new technique to create yeast strains that are then pitted against natural strains. By doing so, researchers hope to understand whether the exact location of genes on the chromosomes is an accident of evolution or if it confers a selective advantage to the organism. (New Scientist, 8 March 2003)

MEDICAL BIOTECH

Patent covers zinc finger DNA-binding proteins

Sangamo BioSciences Inc. has been granted a United States patent entitled Regulation of Endogenous Gene Expression in Cells using Zinc Finger Proteins. The patent (No. 6534261) includes claims covering the activation or repression of any endogenous gene in any cell type using zinc finger DNA-binding proteins. The basis of this fundamental patent that covers the regulation of any gene in any cell type is the regulation of endogenous genes with engineered zinc finger DNA-binding protein transcription factors (ZFP TFs). Although the sequence of many therapeutically relevant genes have been patented as isolated or purified sequences, a key benefit of Sangamos unique technology is that it regulates endogenous cellular genes and is consequently independent of such patents.


Zinc finger DNA-binding proteins (ZFPs) are the dominant class of naturally occurring transcription factors in organisms from yeast to humans. Transcription factors, which are found in the nucleus of every cell, bind to DNA and regulate gene expression. Though there are many kinds of transcription factors, only zinc finger DNA-binding proteins are amenable to engineering and precise targeting to a particular gene/s of interest. Since the over-expression or under-expression of individual genes is the basis for many diseases, the ability to regulate genes with engineered ZFPs has enormous potential therapeutic benefit. The patent covers methods for the activation or repression of endogenous genes, including human vascular endothelial growth factor (VEGF), a gene that plays a critical role in the formation of new blood vessels. 


Chronicle Pharmabiz, 27 March 2003

Molecular signals of lymph-blood separation explored

In the United States, researchers at the University of Pennsylvania School of Medicine report to have discovered molecular signals essential to separate lymph vessel network from that of blood vessels. During foetal development, cells from the newly emerged blood circulatory system start out on their own and form a parallel network of vessels known as the lymphatic system. According to the team, the proteins SLP-76 and Syk previously known to have a signalling function in WBC development are absolutely necessary in separating the lymphatic system from the circulatory system. This new role is important to help learn how to influence the growth of blood or lymphatic vessels. For example, under some clinical circumstances it would be beneficial to encourage the growth of new blood vessels or, conversely, discourage new vessels from supplying blood to growing tumours. 


Express Pharma Pulse, 23 January 2003

Undercover genes slip into brain

Using liposomes that can slip past the brains defences have helped scientists in effectively delivering genes to the brains of primates. This method could be used to treat a host of brain disorders, from Parkinsons to epilepsy. Treating the brain is very difficult since a blood-brain barrier is created by tight junctions between cells lining the capillaries. Only molecules recognized by the cell receptors can get in, unless they are very small. The viruses most gene therapists use to deliver genes are too big and have to be injected directly instead. Even then, the genes are not expressed widely and evenly throughout the brain. Dr. William Pardridge at the University of California, the United States, and his team developed the new technique. First liposomes are coated with polyethylene glycol (PEG), without which they would be purged from the blood within minutes. Next, antibodies that latch on to some of the brain-capillary receptors are tethered to a few of the PEG strands. These antibodies trick receptors into letting the liposomes pass, where they deliver their cargo to brain cells.


The team tested liposomes in rhesus monkeys, using antibodies specific to primate brain receptor. Not only did it work, but the amount of luciferase produced was 50 times greater than in rats. The liposomes do not appear to have any toxic side effects, though they do deliver genes to other organs besides the brain. However, the team has shown that by choosing the right switch to turn on the gene, the gene will be active only in the desired tissue. Since the gene is not integrated into the genome, weekly or monthly injections would be needed for long-term treatment, which is seen as a benefit, since there is no risk of genes lodging permanently in the wrong place thereby triggering cancer.


This method shows promise for treating Parkinsons. The team gave rats a neurotoxin that causes Parkinsons-like symptoms by cutting production of the key enzyme tyrosine hydroxylase. Four weeks later, the team injected the rats with liposomes containing a gene that boosts production of the enzyme. Three days after that the rats abnormal movements were reduced by 70 per cent. 


New Scientist, 22 March 2003

Genetic switch offers hope for treating cancer

A team of scientists from Brunel University, the United Kingdom, and the Swiss Cancer Research Institute in Switzerland have discovered how a genetic switch that allows cancerous cells to divide and spread works. This finding could open up a new avenue to treat most common cancers. The switch controls an enzyme called telomerase. In normal cells, the gene that regulates it is tightly packaged and coiled with the switch off, so the enzyme is not produced and the cells can only divide a finite number of times.


Researchers found that cancer cells manage to unravel the gene and flip the telomerase switch back on, and that blocking the process cuts off the enzyme and cancerous cells stop multiplying. The discovery of how the switch works has implications for therapies because there is a great interest in new drugs that will modify the way genes express (or work). Cancer develops whenever the control signals in a cell go wrong and it mutates. Instead of destroying itself, the cell multiplies uncontrollably and forms a tumour. Although there are more than 200 types of cancer, they all start in the same way. Scientists flipped off the telomerase switch in cancerous cells in the laboratory by adding genes from normal cells that made the telomerase gene recoil into its compact form.


Scientists believe that a drug that targets the gene and the way it is packaged could switch off telomerase in cancerous cells. As telomerase is active in about 85-90 per cent of cancers, a drug that blocks its production could potentially be effective against many different types of cancer. In normal cells it switches off when a foetus is about 20 weeks old and still in the womb. It is believed that this shutting down is a protective process as without the enzyme cells have a finite lifespan they can only divide a certain number of times and this mechanism is involved to protect humans against cancer.


Chemical Weekly, 11 February 2003

Study on cell division may yield targets for obesity treatment

Scientists at John Hopkins School of Medicine, the United States, have shown for the first time that primitive fat cells must copy themselves at least twice before they can mature into full-fledged fat-storing cells. By requiring a primitive fat cell to copy itself at least twice before it matures and cannot divide anymore, nature ensures a ready reservoir of the cells. This is the first evidence which shows that such divisions are necessary for cell maturation. This discovery was made while studying primitive fat cells in mouse. According to Prof. Daniel Lane at the Institute for Basic Biomedical Sciences, Food is not scarce in many parts of the world and storing excess calories may lead to obesity and many serious associated health problems. 


Express Pharma Pulse, 2 January 2003

New biochemical process may help tumour treatment

A novel biochemical process that plays a critical role in helping cells in the body respond to DNA damage like that caused by exposure to radiation, environmental toxins or free radicals has been discovered by scientists at St. Jude Childrens Research Hospital, the United States. According to researchers, these findings could lead to new approaches to prevent cancer, better ways to treat cancer and develop sensitive methods to determine whether people have been exposed to radiation or environmental toxins. This critical early step in a cells response to DNA damage is a chemical modification of an enzyme called ATM that allows the enzyme to initiate a series of events that ultimately halt the growth of a damaged cell and helps it survive.


ATM is activated by a signal from the impaired DNA within seconds after the damage occurs. The activated ATM in turn activates other proteins by attaching a molecule called phosphate to them in a process called phosphorylation. This sets off a cascade of biochemical reactions that amplifies the initial ATM response. Among the proteins phosphorylated by ATM are Brca1 and p53. It is known that these proteins play important roles in preventing cancer and that mutated forms of Brca1 and p53 are responsible for inherited cancers, like familial breast cancer. The new finding is crucial since DNA damage caused by radiation and environmental toxins can lead to mutations or cell death, and can also contribute to the development of cancers. It also provides new insights into the way cells signal to both Brca1 and p53 following DNA damage and this data could help improve therapy for many types of tumours. 


Express Pharma Pulse, 13 February 2003

Stem cell transplant may initiate cancer

It has been found that stem cell transplants could risk seeding cancers, as a single protein may control the proliferation of stem cells and cancer cells. This finding will not only help researchers understand how both types of cell can divide indefinitely but also highlight concerns that stem cell transplants could run the risk of seeding cancer. This discovery should help scientists manipulate stem cells to provide an unlimited source for use in medicine and to do this, scientists must be able to control proliferation so that transplanted cells do not become cancerous. The body normally maintains the ability of certain stem cells to renew themselves so that they can replace cells that wear out. Cancer cells hijack this property to transform into dividing tumours.


Researchers at the National Institute of Neurological Disorders and Stroke in the United States have shown that the protein nucleostemin is abundant in self-renewing cells, such as mouse embryonic and neural stem cells and several human cancer cell lines. By contrast, the protein is scarce in cells that have grown into a mature cell type and can no longer divide. Increasing or knocking down the level of nucleostemin in neural stem cells and cancer-like cells in the lab reduced their proliferation. Although the exact function of nucleostemin is not yet known, it appears to behave like a molecular switch to control cell division. 


Express Pharma Pulse, 9 January 2003

BIOINFORMATICS

Innovative bioinformatic software

An ambitious bioinformatics research programme, which commenced as part of the New Millennium Indian Technology Leadership Initiative (NMITLI) of the Council of Scientific and Industrial Research (CSIR) and Tata Consultancy Service (TCS), is coming out with an innovative software package that can be used for advanced biotech research. A major chunk of the work for the software package is being carried out by TCS, with support from 18 CSIR institutions that are into basic research in biotechnology. The software package is scheduled to be ready for official launch in the near future.


The software, which could possibly compete with leading international products such as those of Accelrys (formerly MSI) of Europe and TRIPOS of the United States, would be versatile, portable and enable upgrading, suitable for parallel processing and capable of offering solutions to the innate imperfections and rigours connected with existing customized packages. CSIR chipped in US$3.3 million for the project. Intellectual property rights arising out of the project is likely to be invested with CSIR institutions and would be shared with TCS also. 


Chronicle Pharmabiz, 16 January 2003

Bioinformatics study

A major bioinformatics study funded by the Netherlands National Computing Facilities Foundation has reportedly completed sequence comparisons of over 400,000 proteins in humans, mice, plants, bacteria and other organisms. Supervised by BioASP, the recently established Netherlands bioinformatics initiative, the collaborative programme combined the expertise of academic organizations in Europe along with that of comparative genomics company Gene-IT, based in France, and Organon, a pharmaceutical company in the Netherlands. Scientists working on the project maintain that their results will enable researchers to better understand disease mechanisms, accelerate drug development and design safer pesticides. It is reported that the protein comparison took the equivalent of 21,600 CPU days. 


Genetic Engineering News, Vol. 23, No. 1, 1 January 2003

PROTEOMICS

DNA protein can eliminate the cause of neuro disorders

Laboratory test results at the University of Alabama, the United States, have shown that a protein typically coded within human DNA can suppress the potentially harmful clumping of other proteins. This discovery has implications in dystonia, Parkinsons disease and other neurological disorders.


According to Dr. Guy Caldwell, many diseases of the nervous system involve aggregates, or clumps, of proteins forming in the cells. Proteins must fold properly within cells to function correctly and one misfolding can lead to another and, subsequently, to aggregation. Aggregation can lead to neuron malfunction or cell death. A specific gene, known as TOR1A (or DYT1), has been linked to the most severe form of dystonia. This gene contains the information to make a protein called torsinA. The study has solved the mystery of torsinAs cellular function, which was previously unknown. 


Express Pharma Pulse, 13 February 2003

Protein fragment that inhibits tumour suppressor identified

Researchers at the Ludwig Institute for Cancer Research in the United Kingdom have identified a protein fragment, belonging to a class of proteins known as apoptotic enhancers (ASPP), that keep at least one major tumour suppressor gene from preventing cancer as it should. ASPP class of proteins are known for their ability to stimulate programmed cell death, or apoptosis, by the p53 gene. However, a member of this group, called iASPP, actually inhibits p53s normal cell killing ability. When the level of iASPP was reduced in experiments on different cell types, investigators found that the wild-type p53 gene could better suppress tumour cell growth, a strong sign that iASPP acts as a natural impediment to controlling cancer. This is the latest addition to a growing list of efforts to attack cancer through the p53 corridor, a major genetic figure in controlling tumour growth. In a remarkably high number of cancers, the p53 gene is mutated and fails to work, allowing tumours to spread. 


Express Pharma Pulse, 23 January 2003

AGRI BIOTECH

Protein-enriched GM potato

Scientists at Jawaharlal Nehru University, India, have come up with a genetically modified (GM) potato. This ubiquitous vegetable has now been fortified with proteins derived from an amaranth (Amaranthus) species, which is also an edible plant, through genetic modification. The scientific community and non-governmental organizations (NGOs) are, by and large, optimistic about this potato variety. Since the introduced gene is from another edible plant, the new strain is considered safe for human consumption. Genetic transfer through pollination is not possible as the tuber is multiplied asexually.


The amaranth gene was inserted into the potatos genetic material using a bacterium (Agrobacterium tumefaciens). Introduction of AmA1 gene in one of the 48 chromosomes of potato resulted in the production of proteins in large amounts. Currently, the second phase of field trials are underway. A Delhi-based NGO cautions that stringent tests should be conducted before releasing the strain for farming. 


Down to Earth, 15 February 2003

DNA markers for rice hybrid assessment

In India, the Centre for Cellular and Molecular Biology (CCMB), in association with the Directorate of Rice Research (DRR), has developed DNA markers for assessing purity in the parental lines of rice hybrids. This technology has received a United States patent covering the DNA markers and PCR-based methodology. An Indian patent has been applied for. The technology has already been tested at the Directorate of Rice Research (DRR) on 100 plants containing a mixture of both cytoplasmic male sterile (CMS) and maintainer lines (male fertile) in the ratio of 4:1 and genotype of all lines was accurately predicted.


CCMB is looking towards commercialization of the new technology and is in talks with seed and biotechnology companies. The seed companies can use this technology to identify parental lines in rice hybrids, thereby supplying quality rice hybrids to farmers. Scientists have also found that this technology can be used to reliably distinguish 12 different pairs of CMS and maintainer lines that are being used for commercial hybrid rice production in India. 


The Financial Express, 21 April 2003

Transgenics for crops

The Andhra Pradesh-Netherlands Biotechnology Programme for Dryland Agriculture (APNLBP) aims to promote application of biotechnologies relevant to small and marginal farmers. Transgenics developed by APNLBP in castor, sorghum, pigeonpea and groundnut are currently being tested in labs and are expected to get into field trials in two years.


According to Dr. M. V. Rao, APNLBP Chairman, this was the first time in the country that transgenics have been developed for these four crops. APNLBP had granted US$0.91 million for setting up seven research projects and US$1.11 million to different universities in Andhra Pradesh towards human resource development in biotechnology. Dr. Rao said that APNLBP had also successfully developed technology to improve the shelf-life of tomato. Using this technology, hybrid tomatoes could be preserved for 42 days while the local variety could be preserved up to nine days without being damaged. In case of custard apple, initial experiments have shown that their shelf-life could be extended by up to 14 days. Tests are underway to standardize this technique and also increase the shelf-life further. APNLBP is currently promoting micro-enterprises at the village level by providing technology and some revolving fund to educate unemployed youth.


BioSpectrum, April 2003

Transgenic trees hold promise for pulp and paper industries

Researchers at North Carolina State University, the United States, have reduced lignin content in trees by 45-50 per cent and achieved the first successful dual-gene alteration in forestry science by genetically modifying aspen trees. According to Dr. Vincent L. Chiang, a professor of forest biotechnology, research has shown that it is possible to not only lower lignin content but also increase cellulose in the transgenic aspens. Moreover, the trees grow faster. Fast-growing, low-lignin trees offer both economic and environmental advantages as separating lignin from cellulose using harsh alkaline chemicals and high heat is costly and environmentally unfriendly. Harvesting such trees, using them as crops with desirable traits, would also reduce pressure on existing forests.


Scientists scratched leaves and bared the wound to bacteria carrying the beneficial genes. Treated leaf-disks, with their enhanced genomic structure, are then cloned, producing trees with predictable qualities. The team modified the expression of a gene called 4CL and a second gene, CAld5H, in the trees. This dual-gene engineering altered the lignin structure, producing the favourable traits of lower and more degradable lignin, higher cellulose and accelerated maturation of the aspens xylem cells. 


Life Sciences World eNewsletter, 3 April 2003

Plant resurrection

Mr. Wu and colleagues at Cornell University, the United States, have borrowed a clever design from nature to engineer rice plants that exhibit higher tolerance to drought, cold and salt. The approach is inspired by so-called resurrection plants, a loosely defined group of flowering plants with a remarkable ability to withstand drought. These plants look like they are dead and gone but spring back to life in the presence of moisture. This death-defying talent is attributed to the presence of high quantities of trehalose, a sugar that stabilizes protein and cellular components in the face of desiccation.


Previous attempts to produce transgenic plants constitutively expressing trehalose synthetic genes were unsuccessful since the transgenes led to faulty metabolism and stunted plant growth under normal conditions. Researchers produced new strains with higher resistance to abiotic stresses by placing two Escherichia coil trehalose synthetic genes under the control of tissue-specific or stress-inducible promoters. 


Nature Biotechnology, Vol. 21, January 2003

PUBLICATIONS

Environmental Biosafety Research

This recently launched journal provides a single forum for the reporting and discussion of environmental GMO biosafety issues involving bacteria, plants or animals. EBR will publish peer-reviewed original research papers and review articles as well as scientific correspondence. All areas pertinent to the biosafety of organisms introduced into the environment will be considered, including:
  • Ecological studies on the impact of novel micro-organisms;
  • Studies of their interactions with pests and pathogens;
  • Food and feed safety evaluation;
  • Impact of novel organisms on agronomy and farming practice;
  • Effect on microbial populations;
  • Economic and sociological studies;
  • Means for reducing or managing risk; and
  • Assessment of horizontal gene flow.

Studies on non-GMOs that illuminate or parallel GMO issues will also be considered.


Contact: Website: www.edpsciences.org 

BioSpectrum

This monthly magazine on biotechnology covers the most important happenings in biotechnology, closely monitoring and analysing developments in the industry, market forces and global trends. It offers a ringside view of the shape of things to come while serving as a clearinghouse for biotech professional and products. Key focus areas include biopharma, bioagri, biogenetics and bioinformatics.


Contact: Cyber Media (India) Ltd., D-74, Panchsheel Enclave, New Delhi 110 017, India; Or Mr. Sanjeeb, New Delhi, India. Tel: +91 (11) 2649 8999/1320; Or Mr. N. C. George, India. Tel: +91 (124) 6381 673-82; 


E-mail: georgenc@cmil.com


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