VATIS Update Biotechnology . Jul-Aug 2008

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Biotechnology Jul-Aug 2008

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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G8 supports biotech’s role in addressing global food security

Leaders of the Group of Eight (G8) industrial nations have agreed that biotechnology could help farmers to increase crop productivity and provide more healthful food around the globe. Addressing the critical issue of global food security, the leaders agreed to “promote science-based risk analysis, including on the contribution of seed varieties developed through biotechnology”. Ms. Sharon Bomer Lauritsen, Executive Vice-President for Food and Agriculture of the Biotechnology Industry Organization (BIO), issued the following statement in response to this action at the G8 Summit in Japan: “As these leaders have said, now is the time to invest in science-based solutions to better achieve sustainable food and fuel production. Biotechnology is already providing those solutions to farmers globally with biotech plants that can produce more with lower costs per acre while being resistant to disease and pests.”

Scientists have determined how to fortify some food plants such as the cassava, a staple root crop in many developing countries, with enough vitamins, minerals and protein to provide the poor and malnourished with a day’s worth of nutrition in a single meal. Studies are also under way to extend the shelf-life so that foods can be stored longer or shipped further with fewer losses. Agricultural biotechnology has environmental benefits too because biotech crop varieties require less tilling and pesticide applications, thereby saving fuel and reducing carbon dioxide emissions into the air. This can also improve soil health and water retention.


New regulatory body in India for recombinant pharma products    

Indian drug companies planning to launch recombinant biologics, DNA vaccines and other genetically modified (GM) pharma products may come under the ambit of the proposed National Biotechnology Regulatory Authority (NBRA). At present, the approval for these drugs – right from their clinical trials to market authorization – is vested in the Drug Controller General of India (DCGI). The Department of Biotechnology’s draft NBRA Bill, 2008, seeks to amend the Drugs and Cosmetics Rules (8th Amendment), 1988, to exclude recombinant pharmaceuticals from the DCGI’s purview and transfer it to the proposed new regulator. Thus, vaccines containing living genetically engineered organisms, recombinant blood and plasma-derived products, such as clotting factors and gene therapy products, would come under NBRA’s scanner.

Officials, however, clarified that the NBRA’s regulatory role will be confined to only drugs with living GM organisms (GMOs). That would, for example, include live vaccines used for polio, measles and tuberculosis but not human insulin or the recombinant hepatitis-B vaccine (whose active ingredients are products derived from GMOs, but not themselves living GMOs). The NBRA will thus take over not only some of the functions of the DCGI, but even that of the newly created Food Safety and Standards Authority. The Genetic Engineering Approval Committee under the Ministry of Environment and Forests, which currently authorizes the testing and commercial release of GM crops, would also become redundant.


Massachusetts allocates US$1 billion for biotech industry 

In the United States, Massachusetts Governor Mr. Deval Patrick signed a measure that will allocate US$1 billion to the biotechnology industry over 10 years. The measure includes US$250 million in tax incentives for biotech companies, and US$250 million in grants for research, fellowships and workforce training. Half of the allocation, US$500 million, is for infrastructure, including a stem cell bank at the University of Massachusetts Medical School.

The bill is intended to fill a funding shortfall caused by a ban on the use of federal funds for human embryonic stem cell research as well as to challenge California’s dominance in the field. Federal funding for embryonic stem cell research is permitted only for research using embryonic stem cell lines created on or before 9 August 2001, under a policy announced by President Bush on that date. California voters in 2004 approved a plan to invest US$3 billion of tax funds over 10 years into embryonic stem cell research. The Governor said the measure will help researchers develop cures for diseases and create new jobs in the state.


China approves big budget for GMO amid food worries 

China’s cabinet has approved a huge budget for research of genetically modified (GM) crops amid growing concerns over food security, a move that scientists say may speed up commercial production of GM rice or maize. The State Council, or cabinet, at a meeting chaired by Premier Mr. Wen Jiabao, gave the green light to a programme aimed at promoting indigenous GM crops. According to Chinese scientists, the programme includes a large increase for transgenic research, including a big portion to develop safety measures for GM crops until the year 2020. “There is significant growth in budget at between US$584 million and US$730 million in the coming years,” stated Prof. Lu Barong of Fusan University and a member of the country’s biosafety committee with the agriculture ministry.

The programme aims to obtain genes with great potential commercial value whose intellectual property rights belong to China and to develop high-quality, high-yield and pest-resistant GM species. The cabinet also urged relevant authorities to speed up the implementation of the programme, in view of its importance and urgency. China, the global leader in developing GM rice, has put off commercialization of such varieties due to global consumer concerns, partly fuelled by GM rice contamination in rice products exported from the country.


Indian biotech sector grows by 20 per cent

An industry survey has revealed that India’s fledgling biotechnology sector posted US$2.56 billion in revenue during 2007-2008, registering a 20 per cent growth over the previous fiscal at US$2.1 billion. “Though the sector grew at a healthy 20 per cent, it was lower than the 30 per cent growth posted over the previous five consecutive years, largely due to the rupee appreciating by 12 per cent and pricing pressures impacting export earnings,” said Mr. N. Suresh of BioSpectrum, which commissioned the survey. Association of Biotech Led Enterprises conducted the survey.

The survey noted that 56 per cent of the sector’s revenue (US$1.44 billion) was generated from exports. Biopharma accounted for about 70 per cent of exports and bioservices 26 per cent. The top 20 home-grown firms accounted for 48 per cent of the total biotech market. Pune-based Serum Institute tops the sector for the third consecutive year followed by Biocon, Panacea Biotech and Nuziveedu Seeds. The Hyderabad-based Nuziveedu Seeds ranked first in the bioagri segment, relegating Salem-based Rasi Seeds to the next position. Bioservices posted highest growth rate at 43 per cent, followed by bioinformatics at 31 per cent.


India adopts new guidelines for GM plants and foods 

India’s Genetic Engineering Approval Committee (GEAC) has adopted a new set of guidelines, standard operating procedures (SOPs) and protocol introduced by the Review Committee on Genetic Modification for the safety assessment of genetically engineered plants and the foods derived from such plants. The new set of procedures is a step in the direction of implementing rigorous and scientifically sound approval system for genetically modified crops and foods.

The new approval system – which is built on the inter-ministerial expertise on biotechnology, including the Department of Biotechnology, Ministry of Environment and Forest, Ministry of Agriculture and Ministry of Health – will replace the existing cumbersome system of approval. The new system includes:

• Guidelines for the conduct of field trials of regulated, genetically engineered plants in India and SOPs;
• Protocol for safety assessment of genetically engineered plants; and
• Indian Council of Medical Research guidelines for the safety of foods derived from genetically engineered plants in India.

Contact: Dr. K.K. Tripathi, Advisor, DBT, India; Or Website:


Source: www.seed


Invitrogen to buy Applied Biosystems

In the United States, the research and discovery tools firm Invitrogen Corp. has agreed to buy Applied Biosystems Group – a subsidiary of Applera Corp. that develops and markets systems for analysing nucleic acids, proteins and small molecules – for US$6.7 billion in cash and stocks. Invitrogen will pay US$38 per share for Applied Biosystems, 45 per cent of the purchasing price in cash and the rest in stock, stated CEO Mr. Gregory Lucier, who will take the reins of the combined company. The transaction’s cash portion will be paid by cash on hand and about US$2 billion in new debt. Total debt of the combined company will be about US$3.5 billion, Mr. Lucier added. The combined company will generate more than 70 per cent of its revenue from consumables and services. Following the close of the transaction, the combined firm will be named Applied Biosystems Inc.


Eden Biodesign expands Research Triangle Park facility

Eden Biodesign Ltd. confirmed its expansion plans for Eden Biodesign Inc., the group’s subsidiary in the United States, with the announcement of a facility in the Research Triangle Park, North Carolina. Eden Biodesign Inc., will offer a range of cell line/strain development and early process development services. Eden Biodesign provides services in support of all major biopharmaceutical production technologies (mammalian, viral and microbial) and offers a toolbox of expression technologies, some via collaboration with partner companies.

By establishing a subsidiary in the United States, Eden is making it easier for clients to access its proven expertise and inspected cGMP manufacturing facilities and confirming its position as a recognized global player in the contract biopharmaceutical manufacturing services market. Eden is actively developing technology and marketing collaborations with industry leaders throughout North America.


 ThromboGenics and BioInvent in strategic alliance with Roche

ThromboGenics NV and BioInvent International AB announced that they have entered into a licence agreement with Roche for their jointly developed anti-cancer agent. TB-403 is a monoclonal antibody that blocks placental growth factor (PIGF), one of the growth factors responsible for the development of new blood vessels. Under the terms of the agreement, Roche will pay ThromboGenics and BioInvent an upfront payment of €50 million. In addition, ThromboGenics and BioInvent could potentially receive up to €450 million over the term of the collaboration based on the successful completion of a series of development and commercial milestones for multiple indications as well as double-digit royalties on potential product sales, including any back-up antibodies based on inhibition of PlGF. ThromboGenics, which discovered TB-403, will receive 60 per cent and BioInvent 40 per cent of the revenue from the deal. Roche will have a worldwide, exclusive licence to develop and commercialize TB-403. ThromboGenics and BioInvent will retain co-promotion rights for the product in the Benelux, Baltic and Nordic regions.

TB-403 (anti-PIGF) has completed an initial Phase I clinical trial and recently received approval to enter a Phase Ib dose escalation trial. The Phase Ib trial will be commence shortly in Denmark on patients with advanced cancer. TB-403 has the potential to be a major advance in the treatment of cancer. It is a humanized monoclonal antibody that blocks the formation of new blood vessels, which are needed by solid tumours to support their growth. TB-403 has the potential to minimize both the growth and spread of cancer cells.


GSK, Mpex Pharma enter drug development pact    

GlaxoSmithKline (GSK) and Mpex Pharmaceuticals announced their worldwide strategic alliance for the discovery, development and commercialization of novel medicines for bacterial diseases. The collaboration provides GSK access to Mpex’s novel efflux pump inhibitors (EPI) and related proprietary technology for use in combination with a variety of antibiotics. The collaboration will focus on the discovery and development of novel drug regimens comprising Mpex’s EPIs combined with GSK’s novel development stage compounds as well as existing commercial antibiotics to improve potency and broaden the spectrum of antibacterial activity.

Under the terms of the agreement, Mpex will grant GSK rights to product candidates developed under the collaboration that are directed to three different target product profiles and with the potential to deliver up to seven treatment options. Mpex will be responsible for the discovery of EPI drug candidates and the development of combination product candidates through clinical proof of concept, at which point GSK will have an option to exclusively license each product candidate for further development and commercialization on a worldwide basis. Mpex will keep the right to further develop and commercialize product candidates for which GSK does not exercise its option.

Mpex will receive US$8.5 million in upfront payment and US$6.5 million equity financing commitment from GSK. Contingent on achieving certain milestones, Mpex is eligible to receive development, regulatory and commercial milestones ranging up to US$200 million to US$250 million for each product candidate. If GSK exercises its option, Mpex will receive tiered royalties, dependent on sales achieved, for EPIs used in combination with commercially available antibiotics and with proprietary GSK antibiotics. GSK will participate in the alliance through its Infectious Diseases Centre of Excellence for Drug Discovery.


Invitrogen partners with IRC to advance stem cell research

The International Regulome Consortium (IRC) announced that it has signed a non-binding letter of intent with Invitrogen Corp. to develop tools for stem cell research that will aid in the development of new therapies for some of the world’s most debilitating diseases. The agreement was signed at the annual meeting of the Biotechnology Industry Organization. Invitrogen will contribute services and technology to help IRC researchers in their goal of mapping the genetic circuit board that regulates how stem cells give rise to specialized cells such as neurons.

IRC is a third-generation genome project involving 58 researchers from 34 institutions in 12 countries. It builds upon the work of the Human Genome Project, which in 2001 produced a detailed description of the more than 20,000 genes in the human body. IRC is using sophisticated laboratory techniques combined with advanced data analysis to determine how these genes are regulated in stem cells and in the specialized cells they give rise to. The implications of this research are immense, with insights expected to lead to powerful new regenerative approaches for treating and curing disease. Contact: International Regulome Consortium, Canada. Website: www.


Sanofi-aventis to develop new molecules and vaccines

Sanofi-aventis has announced that three new therapeutic antibodies and six new vaccines in development are stemming from agreements it signed in the past year. Therapeutic antibodies target inflammatory or oncology indication. The new vaccines are aimed at fighting against serious infectious diseases such as malaria, tuberculosis, rabies, Japanese encephalitis, West Nile virus and pandemic influenza. With nine major agreements, Sanofi-aventis and its vaccines division Sanofi pasteur are actively partnering with biotech companies to develop molecules and vaccines for the future. Sanofi-aventis and Sanofi pasteur have already committed to R&D partnerships with major universities, research institutes, government bodies and contract research organizations. The list of agreements include:

• A major global collaboration with Regeneron to develop and commercialize fully human therapeutic antibodies. SAR153191, an antibody to the Interleukin-6 receptor (IL-6R) that will be tested in rheumatoid arthritis, is the first therapeutic antibody entering clinical development under the collaboration. The second one is SAR153192, an antibody to Delta-like ligand-4 (Dll4) that will be developed in oncology.
• In a strategic collaboration with Dyax, Sanofi-aventis has been granted an exclusive worldwide licence for the development and commercialization of the fully human monoclonal antibody SAR161578, which has therapeutic potential in solid tumours, as well as a licence to Dyax’s proprietary antibody phage display technology.
• A research collaboration with the Institute of Haematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, to generate therapeutic antibodies directed to acute myeloid leukaemia stem cells.
• Two agreements with Acambis, one on a new, single-dose Japanese encephalitis vaccine and another for the development of a vaccine to prevent West Nile virus disease, which is considered endemic in the United States.

Other agreements include one with the Statens Serum Institut of Denmark on a new tuberculosis vaccine to fill a significant unmet medical need around the globe, another with Crucell on monoclonal antibodies against rabies, a licence agreement with MedImmune on its reverse genetics technology used for pandemic preparedness, and another with Institut Pasteur of France on the development of a malaria vaccine to relieve affected population from this scourge.


NITD and TB Alliance join hands to accelerate TB treatment  

The Global Alliance for TB Drug Development (TB Alliance) and the Novartis Institute for Tropical Diseases (NITD) announced a five-year research collaboration designed to yield new medicines for tuberculosis (TB), including drug-resistant TB. The partnership is a milestone towards the development of faster TB drug regimens that treat all forms of TB, are easier for patients to complete and can be used safely in patients with HIV/AIDS. Under the collaboration, NITD and TB Alliance will share information on new and ongoing TB drug discovery projects. The agreement clears the pathway for future collaborative development of novel antibiotic compounds. This partnership offers the opportunity for significant progress in the TB drug pipeline, which has grown considerably in the last few years due, in large part, to the resurgent efforts of the TB Alliance and its public-private partners. It supports the overall mission of NITD and TB Alliance as both are committed to improving access to medicines and helping reduce the overall global TB disease burden.

NITD relies on establishing key partnerships to augment its research activities and recognizes the importance of such partnerships, such as TB Alliance, to help support the advancement of drug discovery for neglected disease under its not-for-profit mission statement. In 2004, NITD and TB Alliance collaborated to develop potential drugs for the treatment of TB from a class of chemical compounds called nitroimidazopyrans. It is estimated that one-third of the world’s population is infected with Mycobacterium tuberculosis, the TB bacterium.


Pharma giants to collaborate on new discovery technology

Three of the largest pharma companies on the planet are joining forces to back an unusual venture aimed at developing breakthrough discovery technology that can reduce the frequency of trial failures and save them huge amounts of money. Eli Lilly, Merck and Pfizer are joining forces with PureTech Ventures to provide US$39 million to finance the launch of Enlight Biosciences. Enlight, in turn, plans to spin off new companies if the technology looks promising enough. Some of the new technologies the collaboration will explore include finding ways to deliver drugs across the blood-brain barrier and new biomarkers. “Today, drug discovery is tremendously tech-dependent, and many of the pharmaceutical companies are falling behind,” says Enlight co-founder Mr. Raju Kucherlapati, a genetics professor at Harvard Medical School.



Gene mutation improves leukaemia drug’s effect

According to new research at Ohio State University (OSU), the United States, gene mutations that make cells cancerous can sometimes also make them more sensitive to chemotherapy. Led by Dr. Clara D. Bloomfield, OSU researchers studied a cancer and leukaemia clinical co-operative group to find that a mutation present in some cases of acute leukaemia makes the disease more susceptible to high doses of a particular anti-cancer drug. The retrospective study shows that people with acute myeloid leukaemia (AML) whose leukaemic cells have mutations in the RAS gene are more likely to be cured when treated after remission with high doses of the drug cytarabine. It also suggests that testing for RAS mutations might help doctors identify which AML patients should receive high-dose cytarabine as their post-remission therapy. “This appears to be the first example in AML of a mutation in an oncogene that favourably modifies a patient’s response to the dose of a routinely used chemotherapeutic drug,” Dr. Bloomfield states. If confirmed, AML patients in the future will likely be screened for RAS mutations, and those who have one may get high-dose cytarabine for post-remission therapy rather than a stem cell transplant.

The research analysed the outcome of 185 AML patients aged 60 or less who have had complete remission following initial therapy. Thirty-four of the patients (18 per cent) had mutations in the RAS gene, and of these, 22 received high-dose cytarabine and 12 received the drug at low dose. The high-dose patients with RAS mutations had the lowest relapse rate (45 per cent) after an average 10-year follow-up, compared with a high rate (68 per cent) for those with normal RAS genes. “That means 55 per cent of patients with RAS mutations were cured compared with 32 per cent of high-dose patients with normal RAS,” expressed Dr. Bloomfield. Further, of the patients who received low doses of the drug, all those with the mutations had a relapse, as did 80 per cent of those with normal RAS genes.


Gene therapy for heart failure

In a first-ever clinical trial of gene therapy to treat severe heart failure, the New York Presbyterian Hospital/Columbia University Medical Centre is offering this treatment for patients enrolled in the multi-centre Calcium Up-Regulation by Percutaneous Administration of Gene Therapy in Cardiac Disease (CUPID) trial. The patients will undergo a minimally invasive cardiac catheterization procedure that will introduce a specially engineered gene to stimulate production of an enzyme necessary for the heart to pump more efficiently. “The new therapy seeks to replenish the levels of this enzyme by introducing the gene for SERCA2a, which is depressed in these patients. If proven effective, this approach could be an alternative to heart transplant for patients without any other options,” says Dr. Donna Mancini, the study’s principal investigator.

In most gene therapy studies, a normal gene is inserted into the genome to replace an abnormal disease-causing gene. A carrier molecule called a vector must be used to deliver the therapeutic gene to the patient’s target cells. Currently, the most common vector is a non-pathogenic virus most people have been exposed to in adolescence that has been genetically altered to carry normal human DNA.


New ways identified to regulate genes, reduce heart damage

In the United States, researchers at the University of Cincinnati (UC) have been looking for ways to reduce or prevent heart damage by starting where the problem often begins – in the genes. Along with his colleagues, Dr. Keith Jones, a researcher in the department of pharmacology and cell biophysics, is trying to reduce post-heart attack damage by studying the way cells die in the heart – a process controlled by transcription factors. Transcription factors are proteins that bind to specific parts of DNA and are part of a system that controls the transfer of genetic information from DNA to RNA and then to protein. Transfer of genetic information also plays a role in controlling the cycle of cells – from cell growth to cell death.

So far, studies have identified the role for an important group of interacting transcription factors and the genes they regulate to determine whether cells in the heart survive or die after blood flow restriction occurs. The researchers are investigating new, non-viral delivery mechanisms for this transfer of DNA. The researchers have made this successfully work within live animal models. This means the activity of most transcription factors in the heart can be blocked without having to make genetically engineered mice. Dr. Jones said this delivery mechanism involved flooding the cells with decoys that trick the transcription factors into binding to the decoys rather than to target genes, preventing them from activating those genes.


Safer, better gene therapy

The potential of gene therapy has long been hampered by the risks associated with using viruses as vectors to deliver healthy genes. However, a new study at the University of Georgia (UGA), the United States, helps bring scientists closer to a safe and efficient gene delivery method that does not involve viruses. Prof. Yan Geng and his colleagues at the UGA Franklin College of Arts and Sciences have created a novel synthetic gene vector that packages DNA into well-defined nanostructures that allow it to efficiently deliver genes without triggering immune responses. The study may have implications for cancer treatment and vaccine development. The researchers developed a very versatile approach to creating synthetic gene delivery vectors. Their approach is relatively simple – using simple chemical reactions to create a new class of packaging molecules that wrap up genes on their own – and has the potential to be very useful in real world, clinical applications.

Synthetically packaging long strands of DNA into compact, small structures has long been a challenge, but Prof. Geng’s team has developed a unique combinative self-assembly method that allows scientists to control precisely the size and shape of the vector. The team synthesized small peptides – short chains of amino acids – that bind
to genes and emulate natural proteins to minimize potential immune reactions. The researchers then attached the small peptides on to a biocompatible polymer scaffold to create a cluster effect. The clustered peptides of the combined molecule automatically assemble with DNA, while the polymer wraps around the assembly creating a protective shell. The research team has discovered that the assembly process is extremely sensitive to the clustered arrangement of the genebinding peptides. The researchers simply change the attachment density of the peptides on the polymer scaffold, to change the shape that varies from spherical to doughnut shaped to long filaments. “These gene vectors can also be further conjugated with targeting molecules, which will allow us to deliver the right genes to the right spot in our body,” Prof. Geng explains.


New targets for RNAs that regulate genes identified

RNA is emerging as a major player in gene regulation, the process inside cells that drives all biology and that scientists seek to control to fight disease. A new study by scientists at University of Texas (UT) Southwestern Medical Centre, the United States, has found that, contrary to established theories, RNA can interact with a non-gene region of DNA called a promoter region, a sequence of DNA occurring spatially in front of an actual gene. This promoter must be activated before a gene can be turned on. Dr. David Corey, a professor of pharmacology and biochemistry at UT Southwestern and a senior author of the study states, “Our findings about the underlying mechanisms of RNA-activated gene expression reveal a new and unexpected target for potential drug development.”

In previous studies, Dr. Corey and Dr. Bethany Janowski, assistant professor of pharmacology at UT Southwestern and a senior author of the current study, have shown that tiny strands of RNA can be used to activate certain genes in cultured cancer cells. Using strands of RNA that they manufactured in the lab, the researchers showed that the strands regulate gene expression by somehow perturbing a delicate mixture of proteins that surround DNA and control whether or not genes are activated. However, it was not clear until now exactly how the synthetic RNA strands affected that mix of regulating proteins.

In the current study, carried out in cancer cell cultures, the researchers discovered an unexpected target for the manufactured RNA. The RNA did not home in on the gene itself, but rather on a type of RNA produced by the cell, a so-called non-coding RNA transcript. This type of RNA is found in association with the promoter regions that occur in front of the gene. Promoter regions, when activated, act essentially as a “start” command for turning on genes. The researchers found that their RNA strand bound to the RNA transcript, which then recruited certain proteins to form an RNA-protein complex. The whole complex then bound to the promoter region, an action that can then either activate or inhibit gene expression.



Genes that control embryonic stem cell fate identified

Researchers at the University of California-San Fransisco (UCSF), the United States, have found about two dozen genes that control embryonic stem cell fate. The genes may either prod or restrain stem cells from drifting into a kind of limbo, they suspect. The limbo lies between the embryonic stage and fully differentiated, or specialized, cells such as bone, muscle or fat. By knowing the genes and proteins that control a cell’s progress towards the differentiated form, researchers may be able to accelerate the process – a potential boon for the use of stem cells in therapy or study of some degenerative diseases.

“The genes we identified are necessary for embryonic stem cells to maintain a memory of who they are,” says Dr. Barbara Panning, an associate professor of biochemistry and biophysics at UCSF. “Without them the cell doesn’t know whether it should remain a stem cell or differentiate into a specialized cell.” The team used a powerful technique known as RNA interference, or RNAi, to screen more than 1,000 genes for their role in mouse embryonic stem cells. RNAi can knock down individual genes, reducing their abundance to determine the gene’s normal role.

The study focused on proteins that help package DNA. In the nucleus, DNA normally wraps around protein complexes called nucleosomes, forming a structure known as chromatin. This is what makes up chromosomes. The researchers found 22 proteins, each of which is essential for embryonic stem cells to maintain their consistent shape, growth properties and pattern of gene expression. Most of the genes code for multi multiprotein complexes that physically rearrange, or remodel nucleosomes, changing the likelihood that the underlying genes will be expressed to make proteins.


New mode of gene regulation uncovered in mammals

Researchers at the University of California-Santa Cruz (UCSC), the United States, have discovered a type of gene regulation never before observed in mammals: a ribozyme that controls the activity of an important family of genes in several different species. The findings describe a new and surprising role for the so-called hammerhead ribozyme, an unusual molecule previously associated with obscure virus-like plant pathogens called viroids. The UCSC researchers found the ribozyme embedded within certain genes involved in immune response and bone metabolism in rats, mice, horses, platypuses and several other mammals.

A ribozyme, or RNA enzyme, is an RNA molecule that can catalyse a chemical reaction. When a gene is activated, or expressed, its DNA sequence on the chromosome is transcribed into an RNA molecule known as messenger RNA or mRNA. The mRNA sequence is then translated into the amino acid sequence of a protein molecule, and the protein then carries out the gene’s function in the cell. In the genes studied at UCSC, the mRNA contained sequences that assemble to form an active hammerhead ribozyme. The hammerhead ribozyme is a self-cleaving molecule that can cut itself in two. This self-cleaving action effectively turns off the genes by preventing protein translation. Presumably, another mechanism exists to turn on the genes by stopping the selfcleaving of the ribozyme.



New stem cell therapy may aid repair of damaged brains

According to some experts, newly born neuronal stem cells in the adult brain may provide a therapy for brain injury. However, for these stem cells to be used, the process by which they are created, neurogenesis, must be regulated. A new study led by Dr. Laurence Katz, Co-director of the Carolina Resuscitation Research Group, at the University of the North Carolina’s School of Medicine in the United States, suggests a way to achieve this objective.

According to the study, induced hypothermia can regulate neurogenesis. In rat subjects, a mild decrease in body temperature was found to substantially decrease the proliferation of newly born neurons, a discovery that marks a major step forward for the development of neuronal stem cellbased brain therapies. “Many questions remain before we adequately understand how to control these cells to repair a damaged brain,” says Dr. Katz. “However, the findings represent an important step in demonstrating that these cells can be controlled by simple external forces like hypothermia.”



Inhalable form of gene therapy for treating lung diseases

A new inhalable form of gene therapy – based on technology recognized in the 2006 Nobel medicine prize – shows increasing promise for treating lung cancer, infectious diseases and inflammatory lung disease. Dr. Sally-Ann Cryan and her colleagues at Royal College of surgeons, Ireland, focused on the development of an inhalable form of RNA interference (RNAi), a gene therapy technique that interferes with or “silences” genes that make disease-causing proteins. The researchers explain that RNAi has advantages over other gene therapies. It is potent, very specific and appears to have a low risk of side-effects. They cite encouraging results with RNAi in laboratory studies in cells and animals with a range of lung diseases, including lung cancer, certain respiratory infections and inflammatory lung disease. The keys to successful therapy in humans include careful design of the gene-silencing agents, determining the most effective doses and developing better ways of delivering RNAi agents to the lungs.



Adult stem cell findings offer hope for Parkinson’s cure

A recent study at Griffith University, the United States, provides evidence that a Parkinson’s disease cure could lie just inside the nose of the patient. The study found that adult stem cells harvested from the noses of Parkinson’s patients gave rise to dopamine-producing brain cells when transplanted into the brain of a rat. The debilitating symptoms of Parkinson’s, such as loss of muscle control, are caused by degeneration of cells that produce the essential chemical dopamine in the brain. This discovery is the result of research undertaken at the National Centre for Adult Stem Cell Research, part of Griffith’s Eskitis Institute for Cell and Molecular Therapies.

According to project leader Prof. Alan Mackay- Sim, researchers simulated Parkinson’s symptoms in rats by creating lesions on one side of the brain, similar to the damage that Parkinson’s causes in the human brain. The lesions to one side of the brain made the rats run in circles. When stem cells from the nose of Parkinson’s patients were cultured and injected into the damaged area, the rats re-acquired the ability to run in a straight line. This proved that the cells had differentiated to give rise to dopamine-producing neurons influenced by being in the environment of the brain. In vitro tests confirmed the presence of dopamine. Significantly, none of the transplants led to the formation of tumours or teratomas in the host rats, as had occurred after embryonic stem cell transplantation in a similar model.


Cell-based pandemic vaccine successful in human trial

Baxter International, based in the United States, reports that a human trial of its Celvapan bird flu vaccine has demonstrated its ability to spur an immune response against three strains of the lethal virus. This is the first time that researchers have developed a flu vaccine using a virus grown in cell cultures rather than eggs. The new procedure is expected to be significantly faster and more efficient than the traditional manufacturing method. That would be particularly important in the event a manufacturer was racing to produce large quantities of a vaccine to prevent a pandemic. “It is not the complete answer to a possible pandemic, but it is one of many vaccines that look like they may be able to fight off a bird flu pandemic,” states Dr. John Trenoar of the University of Rochester.


New source of heart stem cells discovered

In the United States, researchers at Children’s Hospital Boston are continuing to document the heart’s earliest origins. Now, they have pinpointed a new, previously unrecognized group of stem cells that give rise to cardiomyocytes or heart muscle cells. These stem cells, located in the surface of the heart or epicardium, advance the hope of being able to regenerate injured heart tissue.

This finding comes on the heels of parallel cardiac stem cell discoveries in 2006, at both Children’s and Massachusetts General Hospital (MGH). Then, the Children’s team found that a specific stem cell or progenitor, marked by expression of a gene called Nkx2-5, forms many components of the heart, such as heart muscle cells, vascular smooth muscle cells and the endothelial cells lining blood vessels in the heart’s left-sided chambers. The team at MGH found a related progenitor, marked by expression of the Isl1 gene that produces these same cell types in the right-sided heart chambers. Now, researchers at Children’s have shown that heart muscle cells can also be derived from a third type of cardiac progenitor, located within the epicardium and identifiable through its expression of a gene known as Wt1.


Mechanism that prevents cells from turning cancerous

Scientists at the MRC Clinical Sciences Centre at Imperial College-London have discovered a mechanism that prevents cells from transforming into cancer cells. As cells age they enter a state called senescence, a kind of suspended animation that allows a cell to keep functioning but prevents it from changing. This state can also be triggered by what is called an “insult” to the cell, for example, a signal from a cancer-initiating gene.

The team investigated a number of genes, receptors and signalling molecules the cell uses to preserve itself. The researchers revealed how some of these signalling molecules are secreted by senescent cells to reinforce the message to halt growth. According to Dr. Jesus Gil who led the research, “Previous studies have shown that senescent cells accumulate in lesions that can become malignant so it is important to learn how cells reach this stage and how they behave afterwards. Understanding how cells control their growth as they age provides an insight into how cells self-regulate to prevent cancer arising.” The process of senescence begins in response to cell stress, the cell stops itself from replicating any further to prevent it from passing on the damage; so senescence protects the cells from transforming into cancer cells. By looking for evidence of the mechanism that extends the life of cells, the researchers have been able to identify a selfamplifying process in which stressed or aging cells reinforce the message to stop growing.


New strategy to rapidly describe outbreak strains

In the event of a pandemic or a bioterrorist attack, rapid identification of the genetic changes responsible for virulence or drug resistance is essential to mounting an effective response. Standard DNA sequencing and analysis of a pathogen genome is time-intensive and likely impractical during an emergency. Researchers have now developed a comparative genomics strategy to drastically cut the time needed to accurately identify unique genetic properties of a potential outbreak strain.

The researchers led by Dr. Bernard La Scola and Dr. Didier Raoult of the French University of the Mediterranean set out to determine whether a rapidly sequenced incomplete genome could be used to quickly characterize an outbreak strain by comparative analysis. They sequenced a strain isolated from a tularaemia patient using the Roche/454 Life Sciences GS20 sequencing system, and compared these sequences with other strains of Francisella tularensis, the causative pathogen of tularaemia, including a strain with low pathogencity and an antibiotic-resistant strain. The scientists
demonstrated that next-generation sequencing of a bacterial genome without finishing could be used to effectively identify several unique features of the F. tularensis clinical strain in a matter of weeks. Furthermore, they were able to distinguish the clinical strain from 80 other strains of F. tularensis.



Fruit fly gene study could yield new flu treatments

Scientists may be able design new drugs to stave off viral infection by targeting one of more than 100 proteins inside host cells on which the virus depends. These potential drug targets are the result of a study undertaken by researchers in the United States. The scientists tested the ability of a modified influenza virus to infect fruit fly cells. “Our findings give us considerable hope that, with a large number of host targets to choose from, we could develop drugs to more stably suppress the virus and not allow the virus to evolve nearly as quickly to generate resistance,” said Dr. Paul Ahlquist from the Howard Hughes Medical Institute. Dr. Ahlquist worked on this project along with Dr. Yoshihiro Kawaoka at the University of Wisconsin-Madison.

A great many fruit fly genes have counterparts in humans, and the researchers could analyse the function of individual fly genes using a technique known as RNA interference (RNAi). Hence, the researchers genetically altered influenza virus so that it could infect cultured fruit fly cells grown in the laboratory. They also added a gene that would produce a tell-tale fluorescence when the virus successfully replicated in fly cells. Then they used RNAi – treating fly cells with small RNA snippets – to individually suppress the function of each of the 13,071 genes, representing 90 per cent of all fly genes. If a gene is important for allowing the virus to replicate, fly cells in which that gene had been shut off would not emit the fluorescent signal signifying infection. Using this screen, the researchers identified more than 100 host cell genes that the virus depended on for infection.




Protein could lead to new HIV treatments

By identifying a protein that restricts the release of HIV-1 virus from human cells, scientists believe they may be closer to identifying new approaches for HIV treatment. A research team from Emory University School of Medicine, Vanderbilt University School of Medicine and Mayo Medical School has identified calcium-modulating cyclophilin ligand (CAML) as the cellular protein that inhibits the release of HIV particles. CAML works by inhibiting a very late step in the virus life cycle, leading to the retention of HIV particles on the membrane of the cell.

The virus has developed a means of counteracting CAML, through the action of the viral Vpu protein. When Vpu is absent, HIV particles do not detach from the plasma membrane and instead accumulate by a protein tether at the cell surface. When the researchers depleted CAML in human cells in the laboratory, they found that Vpu was no longer required for the efficient exit of HIV-1 particles from the cell. However, when they expressed CAML in cell types that normally allow particles to exit freely, the particles remained attached to the cell surface.



Potential biomarker panel for early stage pancreatic cancer

Researchers from Fred Hutchinson Cancer Research Centre, the United States, have identified proteins that appear in increased numbers at an early stage of pancreatic tumour development in a mouse model. According to senior researcher Dr. Samir Hanash, “Our team identified, for the first time, protein changes associated with early stage pancreatic tumour development in genetically engineered mice that were also found to be associated with the presence of the disease in humans at an early, pre-symptomatic stage.” The scientists tested a panel of five proteins, selected because they showed elevated levels at an early stage of tumour development in a mouse model, in a blind study in 26 humans from the Carotene and Retinol Efficacy Trial (CARET) cohort. The panel of proteins discriminated pancreatic cancer cases from matched controls in blood specimens obtained between 7 and 13 months prior to the development of symptoms and clinical diagnosis of pancreatic cancer. The next step will include validating additional candidate biomarkers and further testing of the biomarker panel they assembled to see how well it distinguishes between pancreatitis and pancreatic cancer.



Proteins could relate to increased longevity in women

Scientists in Spain and Italy have identified a group of proteins in laboratory rats that could help explain two enduring medical mysteries – why women live longer than men and why calorie restriction stands as the only proven method of extending longevity. Their study could help scientists understand the biochemical underpinnings of aging. In the study, Mr. Adamo Valle and colleagues point out that women, on average, live years longer than men. Previous studies also have shown that diets extremely low in calories consistently increase maximum lifespan in a wide range of animals. Scientists have speculated that the explanation may involve hormones, stress, cardiovascular protection and other factors.

Using lab rats as stand-ins for humans, the researchers found that the livers of both female rats and calorie-restricted rats produced different levels of 27 proteins than male rats or those on a normal diet. The findings suggest that a previously unrecognized set of cellular pathways may be involved in the longevity increase from being female and eating a sparse diet. These insights could lead to new ways of boosting human longevity.


Killer enzymes play key role in cell fate

According to researchers at Baylor College of Medicine (BCM) in Houston, the United States, the road to death or differentiation follows a similar course in embryonic stem cells. “Caspases, also known as killer enzymes, that are activated during programmed cell death, are also active in the initial phases of cell differentiation,” states Dr.Thomas Zwaka, assistant professor in the Stem Cells and Regenerative Medicine Centre at BCM.

Programmed cell death (apoptosis) is a specialized form of differentiation. In laboratory studies, Dr. Zwaka and colleagues found an overlap between the pathways that drive cell death and cell differentiation in a group of enzymes called caspases that trigger differentiation. If specific caspase enzymes are removed, stem cells have a differentiation defect. When caspase activity is artificially increased, the cells differentiate. When the team increased the enzyme activity even more, the cell went into apoptosis. In studying how caspases achieve this activity, it was found that the enzyme is a protease or molecular scissors that cleave or cut proteins at specific points. In particular, they found that caspase cleaves Nanog, one of the transcription factors key to maintaining the embryonic stem cells in their selfrenewal state. “This is a proof of concept study,” said Dr. Zwaka. “It shows a strong link between cell death and differentiation pathways. We hope this is a general concept that we can apply in other kinds of stem cells.”


Protein deepens understanding of autoimmune diseases

Researchers in Sweden have identified a protein
called NALP5, which opens new possibilities of
understanding APS-1 – a rare hereditary disease
where the immune system attacks the body’s
own organs – and other autoimmune disorders.
This discovery allows researchers to understand
the first phase of autoimmune disorders in general,
where immune cells, instead of attacking
alien bacteria and viruses, erroneously attack the
body’s own tissue. In an experimental situation, the
researchers “will be able to compare the immune
defence with exactly the same target protein in
humans and in an animal model,” said Dr. Mohammad
Ali Mohammadi at the Department of Medical
Sciences, Uppsala University.

The parathyroid glands regulate the body’s calcium.
The fact that NALP5 was discovered in the
parathyroid glands boosts understanding of their
functions. NALP5 not only functions as a target
for the immune cells in humans, but also in animal
models for the disease that have the same
genetic defect as APS-1 patients. In the future, this discovery can pave the way to develop drugs
and treatment methods for diseases producing
disturbances in the calcium balance, such as
osteoporosis. NALP5 also makes it possible to
diagnose the disease early, so that patients can
receive the appropriate treatment. (Source: www.




Food-borne pathogens effectively killed in minutes

Researchers at the University of Georgia, the United States, have developed an effective technology for reducing contamination of dangerous bacteria on food. The new antimicrobial wash rapidly kills Salmonella and E. coli O157:H7 on foods, including fragile lettuce, tomatoes, fruits, poultry products and meats. It is made from inexpensive and readily available ingredients that are recognized as safe by the United States Food and Drug Administration. The new technology – which has commercial application for the produce, poultry, meat and egg processing industries – is available for licensing from the University of Georgia Research Foundation Inc., which has filed a patent application on the new technology.

The new antimicrobial technology, developed by Mr. Michael Doyle and Centre for Food Safety researcher Mr. Tong Zhao, uses a combination of ingredients that kills bacteria within one to five minutes from application. It can be used as a spray and immersion solution, and its concentration can be adjusted for treatment of fragile foods, such as leafy produce, more robust foods, such as poultry, or food preparation equipment and food transportation vehicles. The effectiveness, easy storage and application, and low cost of this novel antibacterial make it applicable not only at food processing facilities, but also at points of sale and at home, restaurants and military bases.



 Bt brinjal seed production

As a penultimate step in the regulatory procedure for the commercialization of genetically modified (GM) crops, the Government of India through its biotechnology regulatory body GEAC, has given it nod for the experimental seed production of Bt brinjal (eggplant) hybrids to Maharashtra Hybrid Seed Company (Mahyco). Mahyco, a leading seed company in India has been at the forefront in successfully introducing cutting-edge biotech products, such as Bt cotton hybrids. The GEAC has permitted experimental seed production of seven Bt brinjal hybrids at Mahyco’s fields. The seeds shall be produced under the strict supervision of the Director Horticulture Research or Director Research of the State Agriculture University to facilitate the monitoring and supervision mechanism as stipulated by the GEAC.

The new hybrid Bt brinjal variety contains cry1Ac gene (EE1 event developed by Mahyco), which makes the crop resistant to the fruit and shoot borer (FSB). A major constraint in brinjal production, the pest can cause significant yield loss and reduce the number of marketable fruits. Farmers often resort to intensive use of pesticides for FSB control. The FSB-resistant varieties have been evaluated in Mahyco and the Indian Institute of Vegetable Research for their agronomic performance, safety and efficacy, particularly their effect on beneficial insects. The FSB-resistant variety is expected to give higher yields with less pesticide use. Mahyco has already transferred this technology to public sector institutions in India, Bangladesh and the Philippines.



Tomatoes as a carrier for Alzheimer’s drug?

According to a team led by Dr. Hyun-Soon Kim from the Korea Research Institute of Bioscience and Biotechnology, the Republic of Korea, tomato could be a suitable carrier for an oral vaccine against Alzheimer’s disease. Although still in the early stages, this research is a promising first step towards finding an edible vaccine against the neurodegenerative disease. Dr. Kim and his team aimed to develop a plant-derived vaccine against Alzheimer’s disease, because ß-amyloid is toxic to animal cells. Tomatoes are attractive candidates as vaccine carriers because they can be consumed without heat treatment, which reduces the risk of destroying the immune stimulation potential of the foreign protein.

The researchers inserted the ß-amyloid gene into the tomato genome and measured the immune responses to the tomato-derived toxic protein in a group of 15-month-old mice. They immunized the mice orally with the transgenic tomato plants once a week for three weeks and also gave the mice a booster seven weeks after the first feed. Blood analyses showed a strong immune resresponse after the booster, with the production of
antibodies to the human foreign protein. It was therefore concluded that although no reduction of existing plaques in the brains of mice was noted with tomato-derived ß-amyloid, this study represents a novel approach in which transgenic plants expressing ß-amyloid protein can be used to produce a vaccine. The team is currently trying to increase the potency of the tomato-based vaccine because fresh tomatoes contain only 0.7 per cent protein and the levels of foreign protein are even lower.


Key genes for hormone production in plants

A team of geneticists and plant biologists from the United States, Czech Republic and Germany has pinpointed a small group of genes responsible for “telling” plants when, where and how to produce a hormone that is key to their development. Auxin and ethylene are two of the most important growth-regulating hormones in plants.

Scientists know that plants respond differently to ethylene, depending upon the type of plant tissue it is applied to, the developmental stage of the plant and the environmental conditions. The presence of auxin often prompts a plant to produce more ethylene. “Auxin controls almost every process in a plant and hence it is very important to understand how and why auxin is produced in the plant,” says Dr. Jose Alonso, assistant professor of genetics, North Carolina State University.

To find out more about how auxin production is triggered, the team identified a mutant strain of Arabidopsis that had a root system insensitive to the growth inhibitory effect of ethylene. Looking at the genome of this mutant strain, the team found that its lack of response to ethylene was due to the changes in a gene called TAA1. This gene produces a protein essential for auxin synthesis: it recognizes the presence of ethylene as its signal to make proteins that in turn synthesize auxin that controls growth. The team found that if the TAA1 gene and two other related genes were “knocked out” or inactive, the plant had only half the normal auxin. The study definitively establishes a relationship between a gene family, tissuespecific ethylene response and auxin production in plants.



Women in Biotechnology

This publication presents a unique study of the relationships and communications among women scientists, particularly those working in biotechnology. This is achieved by creating interfaces or collecting different points of view over several disciplines (i.e. economy, sociology, biology and genetics) to bridge the communication gap among science, the humanities and different feminist groups. Women in Biotechnology is the first step in building a new scientific community that shares a common interest in improving the awareness of women scientists who are not an integral part of the decision-making processes in their respective fields. In this respect, the book endeavours to address the ethical and biopolitical implications in the different branches of contemporary research. It also attempts to promote the need of women holding decision-making power to consolidate the scientific and social responsibility of all scientists.

Career Development in Bioengineering and Biotechnology

The fields of bioengineering and biotechnology are seeing explosive growth and the number of career opportunities is expected to increase twice as fast as for other science and engineering fields over the next decade. This book provides a road map to the broad and varied career development opportunities in bioengineering, biotechnology and related fields. It presents first-hand accounts by eminent practitioners of the technical and interpersonal competencies required to succeed in these fields. Further, the book covers the pitfalls, opportunities and future prospects for career development in each area.

For the above publications, contact: Springer, Distribution Centre GmbH, Haberstrasse 7, 69126 Heidelberg, Germany. Tel: + 49 (6221) 3454 301; Fax: +49 (6221) 3454 229

E-mail: SDC-book




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