The next plenary meeting of IVTIP will be held on:
May 18-19, 2006, Bilbao, Spain
The meeting will be hosted by IVTIP member companies Gaiker, Progenika and NorayBio.
Central themes are 'a bird's eye view of non-testing methods' (day 1) and reports from EC funded projects (day 2).
Since January 1, 2006, the EC's Research DG has been headed by Jose Manuel Silva Rodrigues. His predecessor, Achilleas Mitsos, remains in DG Research in the important post of adviser hors classe.
The Parliament rapporteur on the EUs 7th framework research programme, FP7, Jerzy Buzek, backs the inclusion of allergic diseases under the general health thematic research in the future FP7. He is supported by health NGOs representing both doctors in allergology and patients suffering from asthma and allergies. In the current Commission proposal for FP7, allergies figure only under the food thematic research.
Allergies result from complex interactions between genes and environment. Allergic diseases have dramatically increased since 50 years due to a number of different factors: increased exposure to allergens, pollutants, dietary changes, the way food is processed, housing architecture and water supply. Currently, nearly 1 in 3 children are allergic and 30-50% of them develop asthma.
Allergies have a huge negative impact on health, quality of life, education and career achievement an thus present a major health economic burden for the EU. Prevention, not only treatment, of allergic disease is very important in terms of research for patients.
There are big difference in prevalence of allergies in Europe, the northern countries being 'the most allergic'. The further south the country lies, the less people have allergies, which get even more rare towards the east. "However, allergy prevalence has started to increase in the east as well, propably due to lifestyle changes. Curiously, the United Kingdom stands out for having, by far, the most allergies in Europe.
Currently, GA_LEN, Global Allergy and Asthma European Network, an EU network of excellence under FP6, brings together European research excellence to develop new ways of preventing and managing allergies and asthma.
Source: EurActiv News, April 4
EU business is spending only 44% for Research and Development (R&D) of what Japanese companies are spending, according to new figures by Eurostat. The EU is still the second most important investor into R&D worldwide, but more efforts are needed to drive innovation and create US-style centres of excellence, policy makers, senior researchers and business leaders agreed at the European research and innovation day organised by Microsoft on 6 November 2005 in Brussels.
MEP Jorgos Chatzimakakis (ALDE, Germany) said Europe's problem was not that there is not enough innovation, but rather the relatively weak link between business and research: "What is needed is transforming patents into products."
"The US has most of the world's top universities, and spending per student is two to three times higher than in the EU", said Carl Bildt, the former prime minister of Sweden, who has become a special envoy for the UN. We have a better level of basic education here, but by losing out to the US in higher education it means that they can attract all the best talent, and it's mainly down to money."
Source: Euractiv News, January 3, 2006
A recent expert report argues that public sector demand for new products and services can boost innovation and increase investment in and take-up of related R&D.
The report of the expert group for 'pre-commercial procurement of innovation' suggests that national administrations should come together to share the risks and the benefits of pursuing novel services and products with the providers themselves. A European dimension on pre-commercial procurement would build critical mass on the demand side, stimulate competition and exploit economies of scale and scope, and stimulate the uptake of European research. Finally, co-operation on European level would reduce the risks for the individual procurers of purchasing yet-to-be proven technologies."
Along the same lines the Aho-report Creating an innovative Europe (January 2006) highlighted the need to develop a European level strategy on the matter. The Aho-report considers e-health, pharmaceuticals, energy, environment, transport and logistics, security and digital content as the top large-scale sectors in which market creation is urgently needed.
Source: EurActiv News, March 31, 2006
Under the EC's Innovation programme, an accompanying measure has piloted four services to help start-up companies. The initiative is called SUN&SUP (Start-up networks and start-up providers). The four services are: (1) Invest Academy to help entrepreneurs to understand finance issues and prepare credible business plans; (2) NXD Network, to recruit experienced entrepreneurs to become non-excutive directors, helping start-ups as they develop; (3) Fame, a service enabling start-up to find an appropriate mentor from the pool of experienced entrepreneurs in the area; (4) Fuzzy Set, a novel risk evaluation and decision-making tool for entrepreneurs, in particular for high-tech companies.
For more information: www.sunsup.org
The 2005 industrial R&D investment scoreboard provides a full picture of the competitive situation of the top 700 EU and 700 non-EU firms in the global R&D environment.
Compared to the 2004 scoreboard (see EurActiv 13 December 2004), the new report shows a slight increase (0.7%) of R&D investment by EU companies. However, non-EU companies continue to invest more and faster (6.9%), contributing to the increasing R&D gap.
The 2005 scoreboard also shows that EU companies are less present in highly R&D intensive sectors such as biotechnology, health and information technology and invest more in medium R&D intensive sectors such as automobiles.
The report states that the EU is weak in enabling SMEs to grow into large R&D investors, particularly in emerging R&D intensive sectors. Individually, EU companies such as Daimler-Chrysler or Nokia performed as well as non-EU companies such as Microsoft and Toyota.
Source: Euractiv News, Dec 9, 2005-12-12
Results from the third report on the 2002 Community Strategy for Europe on Life Sciences and Biotechnology.
The report is the third of its kind laying out what needs to be done by the Commission, other European institutions as well as public and private stakeholders to deliver on the aims set out in the Commission's biotechnology strategy of 2002.
The Commission has responded in its report by priorities for future action. Below is the list of current concerns and needs (in red), followed by the intended action at Commission or Member State (MS) level:
(1) Assessment and cost-benefit analysis
of biotechnology and genetic engineering: Action: Commission:
To carry out an independent study on social, economic and environmental
consequences, opportunities and challenges of modern biotechnologyTo
update the Community Strategy on Life Sciences and Biotechnology
well before the European Spring Council 2007
(2) Intellectual Property (IP) Protection:
A simplified, workable and affordable European patenting system
is needed. Enforce implementation of IP Directive
Action: Member States: to fully and swiftly transpose and implement
Directive 98/44/EC
Commission, Member States, interested parties:to continue exploring
whether further harmonisation would be desirable on the issue
of scope of patents of gene sequences
(3) Networking Europe's biotechnology:
Draw on the results of the successful work of informal network
with Member States officials on competitiveness issues.
Action Commission and Member States: to continue co-operation
and exchange of information through the existing Biotechnology
network with Member States.
Member States: to repeat, in 2006, the benchmarking programme
to provide a basis for an exchange of best practices and fine-tuning
of policies. To report on progress in implementation of biotech
strategy
(4) Funding Research in Europe
The 7th Framework Programme
should be designed with a streamlined administration system to
encourage greater participation, and radically increase the number
of participating SMEs.
Action Commission: to simplify procedures and instruments in
FP7 to make participation easier; to bring together relevant
technologies and sectors to develop a European Knowledge-Based
Bio-Economy
(5) Improving the regulatory framework
Review of the pharmaceutical legislation
Registration and licensing procedures of medicines derived from
biotechnology are still too complex and too expensive.
Legislation on Genetically Modified Organisms (GMOs)
Action Member States: MS should remain responsible for the correct
implementation of EU legislation on GMOs that they have adopted;
to play their role in the implementation of the new regulatory
framework on GMOs
Action Commission: to complete labelling thresholds for the adventitious
or technically unavoidable presence of authorised GM seeds in
seeds of both conventional and organic varieties; to increase
cooperation and consensus among decision-makers through a coordination
network
(6) Tissue Engineering.
A clear regulation for human tissue engineered products, harmonisation
of national existing regulations and increased promotion in Member
States is needed.
Action Commission: to finalise legislation aimed at harmonising
authorisation procedures for marketing products/processes from
human tissue engineering, which guarantee a high level of protection
for patients, before end 2005
(7) Genetic Testing.
Lack of an adequate quality assurance system for genetic testing.
Action Commission and Member States: to enhance the EU-wide exchange
of information on best practice and collaboration regarding the
development and use of genetic testing through the open method
of coordination.
Commission: to submit a proposal for a directive on the protection
of workers' personal data in 2005; to analyse the possibility
of setting standards on genetic testing
(8) Pharmacogenetics.
Uncertainty regarding the potential impact of pharmacogenetics
on health care and its ethical, legal and socio-economic implications
Action Commission: To launch initiatives on the potential benefits,
risks and possible new policy issues, including a prospective
study
(9) Bio-Banks.
Ethical concerns regarding the collection and storage of human
biological material
Simultaneous need to optimise the use of bio-banks through collaboration
in order to ensure progress European biomedical science
Action Commission and Member States: Recommendations for general
principles governing bio-banks (data and sample sharing for research
purpose)
The idea of a European Institute of Technology (EIT) was originally proposed by Commission President Barroso as part of the revised Lisbon agenda and the ambitious growth and jobs strategy for the EU to attract the best brains and investors to Europe. The EIT is inspired by and has as its current model the American Massachusetts Institute of Technology (MIT).
While a European stakeholder consultation on the EIT is currently underway, countries are already competing to host the institute.
After France successfully negotiated the creation of the international experimental fusion reactor (ITER) in Cadarache - it has now announced its advanced plans for the creation of a European Institute of Technology (EIT) in Paris. The aim is to stop the 'brain drain' of the best scientists and to turn the French capital into a 'European technology research hub'. The institute, expected to be operational in five to seven years would house around 300 scientists, half of which Europeans, half from all around the world. France seems to have decided to bring its plan forward irrespective of any EU decision (current EU-consultation on EIT) on the subject.
The European research advisory board (EURAB) has warned the Commission against the European Massachusetts Institute of Technology-like ambitions, saying that such a "world-class research institute cannot be created top down" and can only grow over time out of existing research communities and with close relations with the most advanced industries.
Science and Research Commissioner Janez Potoãnik supports the idea of building a network of existing universities rather than creating a new institution.
Source: EurActiv News, October 12, 2005
On December 13, 2005, the EU Council of Ministers agreed on the draft proposal for the new REACH legislation.
Authorisation of most dangerous chemicals
The key remaining point EU ministers had to deal with concerned approval rules for those substances that cause cancer, genetic mutations or reproduction problems, as well as those that accumulate in human bodies and the environment.
Under the Council compromise, the future chemicals agency in Helsinki will grant authorization for these dangerous chemicals only after companies can show that:
In a statement, the UK Presidency said "authorisations should not be granted on the grounds of adequate control in the case of substances that are persistent, bioaccumulative and toxic (PBT) or very persistent, very bioaccumulative (vPvB)".
Precisely under which circumstances can toxic substances be considered to be "adequately controlled" will be defined by the Commission with help from member state experts, using a fast-track procedure ('comitology'). This will be decided within 12 months of REACH coming into force. According to the UK Presidency, the definition will only concern "substances where it is not possible to determine safe thresholds with current methods".
Once adopted, the definition will be inserted in Annex I of REACH which deals with general provisions on how to assess substances.
Exemptions and time limitations to authorisation rules
A number of exemptions have been granted, notably to chemicals used for R&D purposes, which are broadly unaffected by REACH. In what is perceived as a gesture to small businesses, SMEs can be exempted from registration tax if they show "a complete registration form".
Ministers also agreed that the length of time limitations to authorizations granted for the most dangerous substances - those which cannot be replaced under the above conditions - should be decided on a case by case basis. In plenary, Parliament had adopted a one-size-fits-all review for all products of major concern every five years.
Data sharing (OSOR), 'duty of care' and 'right to know'
Ministers have limited the opt-outs to rules obliging companies to share information when submitting group applications under the One Substance, One Registration rule (OSOR). But they dropped the 'duty of care' and 'right to know' principles which would have strengthened companies' responsibility to handle chemicals safely and allowed information to be communicated to consumers.
Not everyone happy
Greenpeace called for the restoration of the chemical substitution clause, stating that the changes leave the door open for hazardous substances and potential carcinogens to stay in use on the market.
"After four years of REACH being watered down under chemical industry pressure, putting into practice a strong substitution obligation is the most important opportunity left to address the growing toxic chemical contamination and to ensure that human health and the environment are given the necessary protection," the group stated.
The European Consumers Organisation (BEUC) also said the Council's decision was a further victory for industry in watering down the aims of the regulation in protecting human health and the environment.
Latest & next steps:
Source: EurActiv News, December 13, 2005
With REACH discussions making progress in Council and Parliament, the chemical industry sector has unveiled a new research agenda for innovation in the next 20 years.European chemistry sector organizations meeting in London on 25 November have unveiled areas for future research and technology developments in the next 20 years.
The research agenda was defined by the Technology Platform on Sustainable Chemistry (SusChem), which is led by the European Chemical Industry Council (CEFIC) and the biotech industry organisation EuropaBio. The technology platform, which has received support from the European Commission, is designed to chart a course for global business leadership and sustainability in the European chemical sector.
Three areas have been defined to focus future research spending:
SusChem will issue the final implementation action plan of the research agenda in mid 2006. A stakeholder event in Munich will take place in July 2006 to discuss the implementation plan.
Source: EurActiv News: Thursday 10 November 2005
Animal extremist activity in the UK was halve in 2005 compared to 2004. The figures indicate the effectiveness of the Serious Organised Crime Act as a deterrent, which came into effect halfway through 2005.
The Association of the British Pharmaceutical Industry (ABPI)'s figures show that, in 2005, there were 85 instances of damage to property compared with 177 the previous year. Even more encouragingly, only 10 were recorded in the last three months of the year - a significant drop on each of the other quarters.
At the same time, the number of abusive or threatening letters and text messages received by companies and their suppliers fell from 108 in 2004 to 36 in 2005. However, the number of "capitulations" - companies and organisations agreeing not to work with those involved in animal research - remained on a similar level, with 103 in 2005 and 113 in 2004.
The number of home visits, where demonstrators gather outside the private homes of people working with or for the pharmaceutical industry to make a disturbance, often in the middle of the night, also showed a drop. There were 57 such visits in 2005, compared with 179 the previous year.
Nevertheless, there have been threats and damage inflicted: for example, damage to the property of Simon Bicknell, the company secretary at GlaxoSmithKline, and to property belonging to Oxford University and customers of HLS. A university boathouse was torched in an attack, while decorators and builders were sent letters warning them dealings with the university were "at your peril." An incendiary device containing explosive fuel was left outside the house of Paul Blackburn, corporate controller of GlaxoSmithKline.
Source: www.DrugResearcher.com, February 2, 2006
Work was halted in July 2004 after a series of threats were made to Montpellier, the contractors working on the buildings. Tactics included sending threatening letters to shareholders, attacking directors' cars and threatening to publish a list of investors on the internet.
In November 2004, a website listing the home addresses and phone numbers of university staff and government ministers was removed from the internet after protests by the university. The university was also successful in winning an injunction stopping protestors gathering outside and intimidating staff.
Understandably, the university is not saying who has taken over the work, nor will it discuss a date for its completion. University registrar David Holmes said: "The university remains firmly committed to the completion of this building which is part of an ongoing programme of replacing and updating existing laboratory space. The new biomedical research building will provide world-class facilities, reflecting the university's commitment to animal welfare and to scientific progress."
"Completing the project will be good for animal welfare, good for medical research and good for the treatment of life-threatening conditions all over the world."
Source: EBRA Bulletin, February 2006
Antidote Europe is a committee opposed to animal experimenting strictly for scientific reasons. The president and a great number of its members are international researchers. The committee wants to inform about the impact on animal experiments on human health and the environment, and to promote true scientific methods.
The danger lies in the fact that the results of animal experimenting are not transposable to the human being, neither are they transposable between animal species. The Committee therefore wants to promote the use of non-animal methods that give a truer prediction of toxicity. Membership costs 15 Euros/year.
Further reading on antidote's website:
Source: www.antidote-europe.org
Antidote is not the only group questioning the value of animal testing, in particular in view of a drugs trial that led to multiple organ failure in six men in the UK in March.
'Animal experiments tell us about animals, not about people. The results of animal studies can never guarantee the safety or efficacy of human medicines or other products because of the fundamental biological, anatomical and biochemical differences between the species. There are countless examples of drugs tested on animals that have been released as safe only to cause serious side effects and even death in humans,' reads a statement by Alistair Currie from the British Union for the Abolition of Vivisection (BUAV).
It is however unknown whether the participants in the UK trial were affected by unanticipated side effects, or whether there was a problem with the manufacture of the drugs, contamination, or a dosage error. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) is currently investigating what went wrong.
Source: CORDIS News, March 23, 2006
At the request of the European
Commission, the Animal Health and Welfare (AHAW) Panel of the
European Food Safety Authority (EFSA) has produced a report on
a number of issues raised in the preparations for drafting the
revision of Directive 86/609 on the protection of laboratory
animals. They looked at the following questions:
(1) The sentience of invertebrate species, and of fetal and embryonic
forms of vertebrate species: the report recommends that the following
invertebrates should come under the scope of the revised directive,
or at least be seriously considered for inclusion: Cyclostomes
(lampreys and hagfish)
Cephalopods (octopus, cuttlefish, squid) Decapod crustaceans
(lobsters, crabs, prawns etc).
In the case of fetal and embryonic forms of vertebrate animals,
the panel recommended that "when a procedure is performed
on a fetus that is likely to produce pain in the newborn or newly-hatched
of that species, adequate anaesthesia and analgesia should be
given provided that the agents used do not significantly increase
the likelihood of fetal mortality. When the procedure might cause
a lasting inflammatory response that persists post-natally, protection
should be given against pain and suffering. A schedule of anaesthetics
and analgesics that are suitable for use in pregnant animals
and fetuses should be prepared."
(2) In which cases animals
used in experiments should be purpose-bred. The review of all
the commonly used laboratory species has concluded that with
the exception of quail (Coturnix coturnix) all the other
species listed should continue to be purpose-bred and some further
species should be added, namely: Chinese hamster (Cricetus
griseus), Mongolian gerbils (Meriones unguiculatus),
two Xenopus species (X. laevis and X. tropicalis) and
two species of Rana (R. temporaria and R. pipiens)."
Which are the most humane methods of euthanasia, and for which
species. Nearly all animals are killed at the end of a research
project, says the report, "and it is important that this
is done humanely, i.e. causing as little suffering as possible
for the animals concerned."
The full report is available on the EFSA web site at http://www.efsa.eu.int/science/ahaw/ahaw_opinions/1286_en.html
A broad-ranging initiative on animal welfare legislation which was introduced by Schweizer Tierschutz (STS), the main Swiss animal protection association, has now been withdrawn. The initiative contained provisions which would have banned animal experiments in the most severe category and required researchers to prove that they could not use non-animal methods instead, when applying for animal research licences.
The main reason for the withdrawal
is the new animal protection law brought in by the government
in December. However, say the STS, they are far from happy with
the new law, and are now launching a call for another referendum
to institute an 'animal protection lawyer'. They will start gathering
signatures in support of this initiative in April.
Under Swiss law, if the signatures of 100,000 voters can be collected
within 18 months, the issue must go to the Parliament.
Source: EBRA Bulletin, February 2006
In January, the European Commission announced that they were launching a "Community Action Plan on the Protection and Welfare of Animals 2006-2010." The objectives of the plan are to define EU animal welfare policy more clearly, to promote higher animal welfare standards and to support the Three R's approach to animal testing.
Specific actions included three relating to animal experimentation that were already part of the existing Commission programme: the Commission-industry partnership on alternatives to animal testing, the next report on the validation and regulatory acceptance of alternatives for cosmetic testing and the 'coordination of the Community position on the adoption' of the revised Appendix A of the Convention on animal experimentation.
The only new action was 'Preparatory work for the establishment of a European Centre-Laboratory for the protection and welfare of animals and the Validation of Alternative Testing Methods." This action probably signals an expansion of ECVAM's remit, to cover areas of animal welfare outside animal experimentation.
Source: EBRA Bulletin February 2006
The number of scientific procedures involving animals in the UK in 2004 was just over 2.85 million, according to the British Home Office, which collates and publishes statistics on animal use. This represented a rise of 2.3% over 2003, and was due to the large increase in the number of genetically modified mice and fish used for research &endash; a rise of almost 20%.
At the same time, the number of procedures using normal animals fell, said the Home Office, including a 12% decrease in primate use. Dogs, cats, horses and non-human primates together were used in less than half of one per cent of procedures.
Source: EBRA Bulletin February 2006
American scientists have demonstrated harmful effects of nano carbon tubes and nano bucky balls. Exposure of cells to these particles resulted in changes in gene expression and disruption in biomolecular processes, such as apoptosis, delay in the cell cycle, changes in cellular transport and infections. The researchers used a combination of high-content imaging analysis and high-throughput genomics.
Exposure to nanomaterials
activates genes, Nanotechweb, 22 November 2005,
http://nanotechweb.org/articles/news/4/11/14?alert=1
The European Science Foundation (ESF) has conducted a two-year foresight study on nanomedicine, the medical application of nanotechnology. The study is first of its kind in Europe and states that the old continent is at "the leading edge of this new wave of technology". Thanks to the tiny size of nanoparticles, nanomedicine tools can manipulate biological systems of human body at a molecular level and may well revolutionise medical care and research.
According to Professor Ruth Duncan from the University of Cardiff, "Europe is at the forefront of R&D in several areas of nanomedicine, including the development of nano-scale pharmaceuticals and drug delivery systems".
However, the study states that there is an urgent need to improve communication, interdisciplinary collaboration and nanomedical education. A regulatory process specific to nanomedical agents must also be created to help translate laboratory findings into clinical applications and marketable products. Otherwise Europe risks losing the medical and economic benefits from the advances of nanomedicine.
More reading: European Science Foundation (ESF): ESF Forward Look on Nanomedicine 2005 (15 December 2005)
Source: EurActiv.com, January 17, 200
Researchers at the University of Illinois have wrapped single-walled carbon nanotubes with double stranded DNA in a way reminiscent of wrapping a pencil with electricity wire. This novel bionanostructure allows the intracellular detection of contaminants.
The system is based on the characteristics of the secundary structure of DNA, of which exist both a natural, right-turning B-form and an alternative, left-turning Z-form, and natural fluorescence of carbon nanotubes in the near-infrared spectrum. The thermodynamics as a result of polymorphistic alternations between the B- and the Z-form influence the electronic structure and optical emission in the near-infrared.
Thge system could be shown to work in practice. Low concentrations mercury could be detected in blood and in living mammalian cells and tissues.
Sources: DNA wrapped Carbon Nanotubes Serve
as Sensor in Living Cells, Medical News Today, 27 January 2007,
www.medicalnewstoday.com/medicalnews.php?newsid=36674
Optical Detection of DNA
Conformational Polymorphism on Single-Walled Carbon Nanotubes,
Science, VOL 311, 27 January 2006, 508-511.
A new 15 million euro research project has been launched to investigate exposure to chemicals in food and the environment and their connection with childhood cancer and immune disorders.
NewGeneris was launched on 1 February 2006 as a new European Integrated Research Project under the Community's 6th Framework Research Programme (FP6). It brings together 25 institutions from 16 European countries with a budget of 15 million euros over five years.
The new research project is part of the EU Environment and Health Strategy (SCALE), launched in 2003 and its related action plan adopted in 2004. It will also feed into the ongoing debate surrounding the REACH proposal to assess and possibly ban chemical substances in the EU.
NewGeneris will look specifically into "maternal exposure during pregnancy to carcinogenic and immunotoxic chemicals" and their effect on young children after they are born. Diseases researchers think might be triggered by the presence of chemicals in humans include cancer, asthma, rhinitis and eczema/dermatitis.
To assess chemical exposure, the researchers will analyse blood and urine samples from mothers and children taken across several 'biobanks' in Norway, Denmark, the United Kingdom, Spain and Greece. In total, around 300,000 mother and baby pairs will be studied, indicated the project coordinators.
The toxic chemicals selected for further investigation include dioxins, PCBs (Polychlorinated Biphenyl), ethanol (alcohol) and other substances ingested by mothers or found in contaminated food, tobacco smoke or polluted air.
Source: EurActiv News, February 1, 2006
American, British and French researchers have completed the mapping of the dog genome using the genome of Tasha, a boxer.
The dog genome is the latest in a growing list of species of which the genome has been mapped. Comnparison of the different genomes of different species yields interesting functional information. Studying the dog genome may also give more knowledge about human diseases. Dogs know approximately 5000 diseases which show strong comparisons with human diseases.
Sources:
The dog has its day, Nature Vol. 438, 8 December 2005,
p 745-746
Genome sequence, comparative analysis and haplotype structure
of the domestic dog, Kerstin Lindblad-Toh et.al., Nature
Vol. 438, 8 December 2005, p 803-819
Pet project: The Dog and Its Genome, Nature Vol. 438,
8 December 2005, p 740
An English/German team of researchers has elucidated the 3D structure of the HIV virus. Because of the variability of the virus, the researchers investigated similiarities between the structures of seventy individual viruses. In addition, various photos were made of the 70 viruses. The photos show that HIV-viruses have a cone-shaped nucleus spanning the width of the viral membrane. The HIV viruses contain a cone-shaped nucleus, spanning the width of the viral membrane. The outer surface contains spikes binding to human immune cells and allowing the virus entry into the cell. With most viruses, the internal structure determines the size; with HIV viruses, the outer membrane determines the size. This limits the various ways in which the virsus can assemble.
Source: Structure, reported in Life Sciences, March 1, 2006
The Ceragenin (CSA) family are synthetically produced small molecule chemical compounds comprised of a sterol backbone with amino acids and other chemical groups attached to them. These compounds have a net positive charge that is electrostatically attracted to the negatively charged cell membranes of certain viruses, fungi and bacteria. CSAs have a high binding affinity for such membranes (including Lipid A) and are able to rapidly disrupt the target membranes leading to rapid cell death.
While CSAs have a mechanism of action that is also seen in antimicrobial peptides, which form part of the body's innate immune system, they avoid many of the difficulties associated with their use as medicines.
Scientists from the Vanderbilt and Brigham Young Universities as well as Ceragenix Pharmaceuticals, demonstrated broad spectrum antibacterial activity with the CSAs with one candidate, CSA-54, potently inhibiting HIV infection of primary human CD4+ T cells, the virus's in vivo targets. Additionally, the compound was found not to be toxic to epithelial cells at concentrations significantly higher than those required to kill the virus.
CSA-54 killed a wide range of HIV isolates, and completely blocked genetically engineered HIV that enters the cells independent of the cell surface receptor the virus normally uses. This finding indicates that CSA-54 most likely attacks the viral membrane and disrupts the virus from interacting with its target cells, similar to some of the known microbicidal peptides. This is important, as a compound that targets the viral membrane is likely to be effective against all strains of the virus, regardless of mutations, as the viral membrane remains unchanged.
Late last year, the company Ceragenix demonstrated the antibacterial properties of CSA-13 against vancomycin resistant staph aureus ("VRSA"), vancomycin intermediate resistant staph aureus strains ("VISA"), vancomycin resistant erterococci ("VRE"), community associated methicillin-resistant staph aureus ("CA-MRSA") and hospital acquired MRSA, as well as key gram negative pathogens such as pseudomonas aueroginosa and E. Coli, and bioterrorism surrogate strains for anthrax, listeria and plague.
Source: www.DrugResearcher.com, February 21, 2006
Researchers at the University of Bonn have discoverd that sunflowers infected with a yeast will produce an antiviral enzyme effective against HIV infection (dicaffeoyl quinic acid (DCQA). Normally, the enzyme is extracted from artichoke or wild chicory, but because of the low content (1,000 dollar/mg), this enzyme is too expensive for medical treatment. With the German discovery, the application of a new group of anti-AIDS medicines comes within reach.
Researchers hope to cultivate sunflowers or cells of other plants in a mix of nutrients and the yeast, resulting in the production of DCQA. It is also being studied which genes are being activated in the sunflower to produce DCQA. Should it be one gene, than genetically modified bacteria might cheaply produce DCQA.
Source:
AIDS-Medikament aus Sonnenblumen, Universität Bonn, Januar
2006,
http://www.uni-bonn.de/Aktuelles/Presseinformationen/2006/005.html
American scientists have developed transgenic pigs producing omega-3 fatty acids. These fatty acids are known for their health effects in humans. The scientists want to use these pigs in studies on the effects of increased blood levels of omega-3 fatty acids on the heart.
The scientists used a 'humanised' gene from Caenorhabditis elegans, a worm whose genome was mapped in 1998. This fat-1 gene encodes for the enzyme n-3 fatty acid synthase. The construct also contained a promotor gene from chicken and a marker gene for neomycin resistance. This construct was transplanted
Source: Researchers Create
Pigs that Produce Heart-Healthy Omega-3 Fatty Acids, Eurekalert,
26 March 2006,
http://www.eurekalert.org/pub_releases/2006-03/uopm-rcp032106.php
Generation of cloned transgenic
pigs rich in omega-3 fatty acids, Liangxue Lai et.al., Nature
Biotechnology, Advance Online Publication, 26 March 2006, http://www.nature.com/nbt/journal/vaop/ncurrent/pdf/nbt1198.pdf
Researchers at the University of Minnesota succeeded in curing monkeys with diabetes type 1. They achieved this feat by implanting insulin producing cells from pigs into the monkeys. Following the implant, the monkeys lived for 6 months without insulin injections and with normal blood sugar levels. The donor cells reside in the liver and are not rejected by using a novel system which does not activate the monkey's immune system.
The researchers are serious regarding clinical research in humans: they are already building special pig keeping facilities.
Source:
U pig cell research offers hope for diabetes cure; By Jeremy
Olson
Pioneer Press Feb. 19, 2006
http://www.twincities.com/mld/twincities/13913256.htm
Grapefruit and oranges contain flavonoids, which have received much attention because of their ability to scavenge free radicals. American and Chinese researchers have now reported that one specific flavonoid, naringenin, has anti-cancer effects beyond that of an antioxidant.
The study, published in the February issue of the Journal of Nutritional Biochemistry (vol. 17, pp. 89-95) looked at the effect of naringenin on DNA repair in human prostate cancer cell cultures (cell line LNCaP). Induction of DNA repair by naringenin may contribute to the cancer-preventive effects associated with an increased dietary intake of fruits containing flavonoids.
The naringenin is proposed to function by stimulating the so-called Base Excision Repair (BER) cellular mechanism that repairs DNA during the replication stage. This was supported by measurable and significant increases in two of the main enzymes in the BER pathway, DNA poly-beta and hOGG1.
This study comes hot on the heels of other research reporting the benefits of grapefruit. Israeli scientists showed that eating a red grapefruit daily could lower blood cholesterol by 15 per cent (Journal of Agricultural and Food Chemistry published on-line, doi:10.1021/jf058171g).
Source: www.DrugResearcher.com, February 17, 2006
Researchers from Lay Line Genomics, a company focused on neurodegenerative and ageing related diseases, used a short-lived fish as an animal model to test the effects of resveratrol on aging-related physiological decay. Resveratrol is an organic compound naturally present in grapes and and particularly enriched in red wine. Resveratrol was added to fish food and fed to the experimental fish. They found that this treatment increased longevity and also retarded the onset of aging-related decays in memory and muscular performance.
Resveratrol appears to be the first molecule to consistently cause life extension across very different animal groups such as worms, insects, and fish, and it could become the starting molecule for the design of drugs for the prevention of human aging-related diseases. The compound was previously shown to prolong lifespan in non-vertebrate model organisms such as yeast, the worm C. elegans, and the fruit fly Drosophila.
However, until now, life-long pharmacological trials were performed in the worm or fly model organisms because of their very small size, very short natural lifespan, and affordable cultivation costs. Laboratory mice, on the other hand, live more than two years and are relatively expensive to maintain, making large-scale, life-long pharmacological trials in mice unaffordable. The fish model seems to be an affordable alternative.
Source: www.DrugResearcher.com, February 21, 2006
The EC-JRC Institute for Health and Consumer Protection, Ispra, Italy has launched a call for expression of interest (CEI) concerning the validation of alternative test methods. All institutions active in the field of animal alternatives testing are called to indicate their interest to collaborate with ECVAM.
All organisations, institutes or companies wishing to be included on the list of service providers are invited to submit an application in accordance with the rules set out in the official notice published in the Supplement to the Official Journal of the European Union on 8th of March 2006 for the purposes specified.
Access to the official notice:
Deadlines and validity of the list resulting from the call for expression of interest:
The list of potential service providers will remain valid for 3 years from the date of dispatch of this notice (24.02.2006). Interested parties may submit an application at any time during the period of validity of the list, with the exception of the last 3 months.
Contact for applications: silvia.bottini@cec.eu.int , Fax: +39-0332-789434
Please consult first the original document of the official notice.
ECVAM's Scientific Advisory Committee of the European Centre for the Validation of Alternative Methods (ESAC) has approved seven new alternative testing methods that will reduce the need for certain drugs and chemicals to be tested on animals. Six out of these tests use cell cultures rather than animals to establish the toxicity of cancer drugs and identify contaminated drugs. Moreover, a new testing strategy has been endorsed to reduce the use of fish in acute aquatic toxicity testing. The tests approved will not only reduce the number of animals needed for testing, but will also increase the accuracy of the tests, thereby making the products concerned safer.
Thomas Hartung, head of ECVAM, said that the new methods will save around 200,000 rabbits per year, which had previously been used to test the substances.
ECVAM now has 23 approved alternative methods, compared to the previous figure of 17.
Changes to EU legislation have required ECVAM to intensify its efforts, and the centre expects to have another four or five methods validated during 2006.
One of the tests is designed to assist the dosage of highly toxic drugs used in chemotherapy. Although rabbits are no longer needed for testing this drug, which can save the life of cancer patients, the method does require the use of mice. The new testing technique involves cord blood cells from humans and bone marrow culture from mice. The mice are anaesthetised before the procedure, but do not survive. The new testing method decreases the risk of a lethal overdose in the first cohort of patients that will receive the drug. This risk cannot be identified with current preclinical testing strategies.
The other five tests will assist the detection of bacteria in drugs (pyrogenicity). The immune system is designed to guard against bacteria, but cannot distinguish between live and dead bacteria. A drug may be sterilised, but still contain traces of dead bacteria. Detection by the immune system can lead to fever, pain and shock. The new method uses human immune cells grown in the laboratory, which can detect bacteria just as the human immune system does. Again, these new tests are more effective than the previous animal tests.
Source: ECVAM at http://ecvam.jrc.it/
A request for comments, nominations of experts, and submission of in vivo and in vitro data for a proposed workshop on alternative methods to replace the Mouse LD50 Assay for Botulinum Toxin Potency Testing was announced in the Federal Register (Vol. 71, No. 18, pp. 4603-4). Copies of the FR notice can be found at: http://iccvam.niehs.nih.gov/docs/FR/7104603.pdf in PDF or http://iccvam.niehs.nih.gov/docs/FR/7104603.htm in HTML.
An Addendum to the "ICCVAM Evaluation of In Vitro Test Methods for Detecting Potential Endocrine Disruptors: ER and AR Binding and Transcriptional Activation Assays." (NIH Publication No. 03-4503, May 2003), is available at http://iccvam.niehs.nih.gov/methods/endodocs/EDAddendum.pdf. The May 2003 report can be accessed on line at http://iccvam.niehs.nih.gov/methods/endodocs/edfinrpt/edreport.htm.
There will be a public meeting for a scientific peer review of the use of two in vitro basal cytotoxicity test methods for estimating starting doses for in vivo acute oral toxicity tests. The in vitro methods are proposed as adjuncts to in vivo acute oral toxicity tests to reduce and refine (i.e. lessen or avoid pain or distress) animal use.
The scientific peer review will take place on Tuesday, May 23, 2006, from 8:30 a.m. to 5:00 p.m., at the National Institutes of Health (NIH), Natcher Center, Bethesda, MD. The meeting is open to the public with attendance limited only by the space available. Go to http://iccvam.niehs.nih.gov/methods/invidocs/panelmeet/regform.htm for online or downloadable fax registration forms.
NICEATM has prepared a Background Review Documents (BRD) on the two NRU test methods, which can be viewed at http://iccvam.niehs.nih.gov/methods/invidocs/brdvalstdy.htm. This document can also be accessed from the ICCVAM home page at http://iccvam.niehs.nih.gov/ the links in the "Announcements" box. For more information on this method, visit the In Vitro Acute Toxicity page at http://iccvam.niehs.nih.gov/methods/invitro.htm."
Information: http://www.regonline.co.uk/eventinfo.asp?EventId=18578%20
Information: http://www.zet.or.at/kongress/Linz2006/
Information: Simcyp website
Information: http://www.hsl.gov.uk/training/pbpk_training.htm
Information: http://www.knt.co.jp/ec/2007/wc6/
Information: http://www.invitox2006.org/
Information: www.mci-group.com
Information: http://www.ict2007.org
Information: http://www.knt.co.jp/2007/wc6