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Draadje Rabies.

90 Posts
Pagina: «« 1 2 3 4 5 »» | Laatste | Omlaag ↓
  1. MeawandMoo1 18 juni 2009 21:21
    quote:

    MeawandMoo1 schreef:

    Rabies in Asia Conference 2009 – Vietnam Chapter
    (September 2009).
    www.worldrabiesday.org/assets/files/R...

    Updated:
    Sponsors: Sanofi Pasteur en Novartis.

    Weinig andere bedrijven maar veel aandacht van verschillende landen en hulporganisaties.

    Wel aanwezig om op 10 September 2009 te presenteren:
    Dr. Lex Bakker Crucell Holland B.V.
    Overview of mAb development including preclinical work and high level US phase II
  2. flosz 18 juni 2009 23:56
    Registratie open tot 31 juli.

    Partners
    run4rabies.org/EN/Our_Partners/Our_Pa...

    Charles Rupprecht is ook aanwezig.(Zie pagina 1)

    Ook op pag. 1, presentatie van Lex Bakker

    Estimated Licensure Date 2012
    Estimated WHO Prequalification Date 2013
    Rabies
    Supplier (1°Partner) Crucell (Sanofi-Pasteur)9
    Vaccine Rabies monoclonal antibody
    Strain / Antigen CL184: CR57 & CR4098 against rabies glycoprotein
    Adjuvant/ Platform Human IgG1 monoclonal antibody, produced on PER.C6
    ********************

    The city of Hanzhong, in China's central Shaanxi province, has ordered the killing of all dogs found outside homes in areas hit hardest by the outbreak. Authorities have ordered "dog-beating teams" to canvass the area and beat dogs to death on the spot -- including those that have been registered by their owners, said Shi Ruihua, head of the livestock department in Hanzhong's agriculture bureau.
    online.wsj.com/article/SB124526320117...

    37,000 animals clubbed to death to contain rabies
    The cull began earlier this month after 13 people died of rabies after being bitten by dogs.
    www.telegraph.co.uk/news/worldnews/as...
  3. flosz 24 juni 2009 08:49
    Van go(mag hier niet ontbreken).:

    Crucell Announces Positive Results of Phase II Rabies Monoclonal Antibody Combination Clinical Study in Philippines

    Leiden, The Netherlands (June 24, 2009) - Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced the results of a second phase II clinical study of its investigational rabies monoclonal antibody combination, which started in May 2008 in the Philippines.

    Crucell has a collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies to be used in association with a rabies vaccine for post-exposure prophylaxis against the fatal disease of rabies.

    This phase II trial was set up as a randomized, single-blind, controlled study in 48 healthy children and adolescents in a high endemic area of Metro Manila, Philippines. The trial was set up to test the safety and tolerability of the antibody product in association with sanofi pasteur's Verorab® rabies vaccine in a direct comparison with the marketed human rabies immune globulin (HRIG) product. It was performed at the Research Institute for Tropical Medicine under the leadership of Dr Beatriz P. Quiambao. The antibody product in association with the rabies vaccine was administered to 16 adolescents as well as 16 children. Its safety and neutralizing activity was compared to HRIG associated with the same rabies vaccine in 8 adolescents and 8 children. The results of the Philippines study showed Crucell's rabies monoclonal antibody combination was safe and well tolerated. Neutralizing activity levels were similar in the subjects administered with the antibody product or with HRIG and all study participants reached adequate immunity levels. This study in children further broadens the population in which Crucell's rabies monoclonal antibody combination could potentially be used. Earlier trials in adult populations have already shown safety and neutralizing activity. Detailed results of this study will be presented at the XX Rabies in the Americas RITA conference in Quebec, Canada on 18-23 October 2009.

    "Our children are at high risk of getting rabies. The results of this study bring closer the moment that all-in-need get an adequate treatment against rabies." said Dr Beatriz P Quiambao, Chief Clinical Research Division and Head, Rabies Research Group, Research Institute for Tropical Medicine, Muntiinlupa, Philippines.

    "We are very pleased with our continued and rapid progress with this next generation rabies treatment and these results help us towards our ambition of reducing the global burden of this deadly disease" said Ronald Brus, Crucell's Chief Executive Officer.

    On February 12th, 2008 Crucell announced that its rabies monoclonal antibody combination was granted Fast Track status by the US Food and Drug Administration (FDA).

    cws.huginonline.com/C/132631/PR/20090...

    www.iex.nl/forum/topic.asp?forum=228&...
  4. forum rang 4 aossa 24 juni 2009 10:09
    SNS Research Morning Note for 24/06/2009

    Crucell (Buy): Positive Phase II results
    The facts: Crucell announced positive results of a second phase II trial conducted with its rabies monoclonal antibody combination drug.

    Our analysis: The positive results of the phase II data included 48 healthy children and adolescents in a high endemic area.
    Like the results in adult patients, the current results show that Crucell's rabies monoclonal antibody combination is safe and well tolerated.
    Development of the drug is done in collaboration with Sanofi Pasteur. Crucell received an initial payment of EUR 10m following the execution of the agreement and is eligible for further milestone payments of up to EUR 66.5m.

    The results are also positive news for Crucell's PER.C6 technology. The rabies monoclonal antibody vaccine will be the second drug to reach phase III clinical trials based on PER.C6.
    Given the fast drug status of the rabies monoclonal antibody drug, we expect Crucell to start phase III clinical trials before year in 2010.
    The product is not expected to reach the market before 2012. But if approval is granted, Crucell's states that this will have a large impact on sales revenues of Crucell, with estimated peak sales to exceed USD 300m.

    Conclusion & Action: The results of the Phase II trial with Crucell's rabies antibody combination drug in children and adolescents is a positive step forwards in the development of the drug. Approval of the drug is not expected before end 2011, however upon approval the drug could drastically increase revenues. We have a Buy recommendation with a target price of EUR 22.50.
  5. flosz 24 juni 2009 10:26
    Van pag.3:
    Estimated Licensure Date 2012
    Estimated WHO Prequalification Date 2013

    Rabies
    Supplier (1°Partner) Crucell (Sanofi-Pasteur)9
    Vaccine Rabies monoclonal antibody
    Strain / Antigen CL184: CR57 & CR4098 against rabies glycoprotein
    Adjuvant/ Platform Human IgG1 monoclonal antibody, produced on PER.C6
    Administration Route IM
    Formulation Liquid
    Presentation TBD
    Dosing Schedule IM: see below
    Target Population for Licensure High risk children, adolescents & adults
    Target Population for Immunization Post-exposure
    Vaccination Coverage Rate Proxy -
    Safety TBD
    Efficacy TBD
    Expected Duration of Protection TBD
    Stage of Development Phase 2
    Estimated Licensure Date 2012
    Estimated WHO Prequalification Date 2013
    www.gavialliance.org/resources/26_Rab...
  6. flosz 26 juni 2009 19:25
    4 Rabies Shots Just As Good As 5
    Posted on: Thursday, 25 June 2009, 10:50 CDT
    The Advisory Committee on Immunization Practices (ACIP), voted on Wednesday to change the standard number of shots needed for rabies from five to four.
    Regulators agreed that four shots given over the first 14 days following rabies exposure was just as effective as giving five shots.
    The ACIP is made up of 15 experts in fields related to immunization. Members have been selected by the Secretary of the US Department of Health and Human Services to advise the US Centers for Disease Control and Prevention.
    The new decision will amount to vaccine conservation as well as a savings for patients, as the typical rabies vaccination from Novartis or Sanofi Pasteur can range from $100 to $200 each.
    Each year, between 20,000 and 40,000 Americans are exposed to rabies, and about 1,000 are given only three or four shots
    www.redorbit.com/news/health/1711573/...

    Novartis AG makes RabAvert and Sanofi-Aventis makes Imovax rabies vaccines that can be used to protect people before or after exposure to a rabid animal.
    Renovations of a Sanofi production plant in France in 2007 created supply problems, and Novartis was unable to meet the increased demand, forcing it to limit use of its vaccine IN 2008 to post-exposure use only, according to the CDC website.
    www.reuters.com/article/domesticNews/...
  7. MeawandMoo1 26 juni 2009 20:45
    quote:

    flosz schreef:

    Stage of Development Phase 2
    Estimated Licensure Date 2012
    Estimated WHO Prequalification Date 2013
    Even een klein track-record overzichtje:
    Van aankondig ontdekking tot start phase I: 757 dagen.

    Fase 1 in United States: 294 dagen
    Fase 1 in India: 240 dagen.

    Laatste fase 1 naar start fase 2: 122 dagen

    Fase 2 in United States: 184 dagen.
    Fase 2 in Philippines: 407 dagen.

    Met een beetje mazzel komt het volgende uit de glazen bol:
    Van fase 2 naar fase 3 in ongeveer 4 maanden. Kan men meteen in Oktober in Canada fase 3 aankondigen.
    (Ik neem aan dat men niet de 3e fase 2 in India afwacht = waarschijnlijk met Novartis).

    Uiteraard één fase 3 in United States.
    Gezien het trackrecord prefereert een studie in India, maar mogelijk is deze markt al verdeeld. (Een land in Zuidoost Azië is daarom aannemelijker maar zal waarschijnlijk ten koste gaan van de snelheid).
  8. [verwijderd] 26 juni 2009 21:11
    How does this compare to the announcement of Flu antibodies? Was this the first story?

    Leiden, The Netherlands, September 27, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced the discovery of a set of human monoclonal antibodies against H5N1. These results, demonstrating the potential of human monoclonal antibodies for pandemic preparedness, were presented today at the 5th International Bird Flu Summit held in Las Vegas, Nevada.

    That would put us about 660 days in, or if Rabies is a pattern, announcement for Phase I would be coming soon.
  9. flosz 7 juli 2009 15:33
    Published online 6 July 2009 | Nature | doi:10.1038/news.2009.627

    A knockout vaccine for rabies?
    Single injection cures infected mice — and it can protect those who haven't yet caught the disease.

    Lizzie Buchen
    A rabies vaccine that reverses the disease in mice after just one injection may pave the way to cheap, effective prevention of the fatal illness.
    Once a person is exposed to rabies — which is most often transmitted by a dog bite — he or she must quickly begin a month-long series of five vaccination shots to prevent the onset of disease. The procedure is effective, but the expense and logistics of multiple shots makes it inaccessible to much of the developing world, where more than 99% of the 55,000 rabies deaths each year occur1.
    Now, a team of virologists and immunologists in the United States have engineered a new strain of the rabies virus that induces a far more potent immune response than current vaccines. In mice already infected with a virulent rabies strain, a single administration of the new vaccine was enough to clear the virus from the body, even after early symptoms had appeared2.
    Conventional post-exposure rabies vaccines consist of inactivated viruses that can't grow or cause infection, and require several injections to produce an appropriate immune response. Live viruses that are 'attenuated' — weakened — induce a much stronger immune response than inactivated virus but are problematic because they may themselves cause disease.

    Sounding the alarm
    Virologist Bernhard Dietzschold and his team at Thomas Jefferson University in Philadelphia, Pennsylvania, wanted to make the new virus strain as safe as an inactivated virus, yet able to rouse the immune response to expunge the infecting virus as quickly as possible.
    Dietzschold realized he could accomplish both goals by tinkering with a protein on the virus's surface. This protein — called the rabies virus glycoprotein (G) — sets off an alarm within the body's immune system but is normally produced at such low levels that the body's defences barely pick it up. Dietzschold's team found that they could ramp up the immune response by inserting three copies of the gene encoding the protein into the viral genome. The researchers were also able to abolish the toxicity of the strain by changing two amino acids in the protein's sequence.
    "When you express a lot of glycoprotein, it makes it a better target because they're the target for the immune system," says co-author Craig Hooper, also at Thomas Jefferson. "But it's also more toxic. For the immune system that's a good thing: If the first cells you infect are going to die, that means you bump up immune response very quickly, so you prevent the virus from spreading."
    To make sure the viral strain they developed didn't cause disease, they injected it directly into the brains of healthy, but very young, mice. Pups as young as five days old did not show any signs of rabies. "This means it's a lot safer than other live attenuated vaccines that are out there," Hooper says.

    Later treatment?
    Dietzschold and his co-workers then infected adult mice with a virulent strain of rabies virus, injecting the pathogen either into muscle or directly into the brain, and found that their new vaccine could prevent onset of the disease if it was administered within three days of exposure.
    "[At present] for humans, we must initiate treatment within 20 hours," says Dietzschold. "We showed we might be able to administer the vaccine later because we can clear the virus even after the onset of early symptoms."
    Finally, the group demonstrated the vaccine's efficacy as a pre-exposure treatment — which is how rabies vaccines are currently used in wild animals and dogs. Mice given the vaccine up to three weeks before being infected with the virus did not develop rabies. "If this proves as safe as we think it is, it could be contemplated as a vaccine where one shot may protect for life," Hooper says.
    In the nearer term, Dietzschold hopes further testing may reveal the vaccine's potential for eradicating the disease in dogs and provide a cheaper and easier alternative to current vaccines for humans.
    Clinician Rodney Willoughby of the Medical College of Wisconsin in Milwaukee, who treats people with rabies and was not involved in the study, is cautious about the new vaccine's potential for treating the disease once symptoms begin. "As far as treatment is concerned, this doesn't bring anything new to the table," he says. That's because if the person is already infected the vaccine could elicit an aggressive immune response in the central nervous system, Willoughby says, which can be harmful and even fatal.
    Willoughby is more optimistic about the usefulness of the vaccine if it is administered before exposure, however. He hopes it paves the way for routine immunization of children before they're exposed to rabies in regions where the disease is widespread, such as parts of Asia and Africa — places where the World Health Organization already recommends pre-exposure vaccinations for travellers. The vaccine's apparent safety and need for just a single administration "allows the economics of vaccination to take a giant step forward", he says.

    www.nature.com/news/2009/090706/full/...

    Bernhard Dietzschold & Crucell:
    O.a.
    jvi.asm.org/cgi/content/abstract/79/8...
    jvi.asm.org/cgi/content/abstract/79/1...
    www.journals.uchicago.edu/doi/abs/10....
  10. bilbo3 8 juli 2009 21:54
    Analyse van beursonline, gaat dieper in op o.a. het Rabies-vaccin

    Voor mij is nieuw dat we phase 3 ingaan en dat we daarom een milestone payment van 10 miljoen ontvangen. Kan iemand dat bevestigen?

    www.beursonline.nl/tips/44361/Kopen-C...

    Kopen: Crucell blijft op koers
    8 juli 2009 18:00

    Aandeel: Crucell
    Koersdoel: 23,-
    Advies: Kopen

    Biotechbedrijf Crucell merkt niet dat er een hogere vraag is naar vaccins als gevolg van de Mexicaanse griep, maar dat de onderneming met dit bericht naar buiten treedt geeft al aan dat de koers van dit aandeel bepaald niet alleen gedreven wordt door het marktsentiment. Testresultaten van nieuwe middelen zijn minstens even belangrijk voor de koers van Crucell als het beursklimaat. In dat opzicht was er onlangs goed nieuws over de zogenaamde PER.C6-technologie, dat als platform dient voor de ontwikkeling van nieuwe medicijnen. Eind juni werd bekend dat een medicijn tegen hondsdolheid veilig is voor mensen en dat het de volgende onderzoeksfase (Phase III) ingaat. Het leverde Crucell 10 miljoen euro aan 'milestone-betalingen' op, maar veel belangrijker is dat met deze stap wordt onderstreept dat de onderneming een goed gevulde pijplijn van nieuwe producten heeft.

    Razendsnelle groei
    In de tweede helft van het jaar worden de onderzoeksresultaten van verschillende andere medicijnen bekend, met Flavimum als voornaamste kanshebber om de koers in beweging te krijgen. Waarschijnlijk wordt nog voor het eind van het jaar een verzoek ingediend om het product op de Duitse markt te introduceren. Ondertussen groeit de afzet van Quinvaxem zo snel dat Crucell nieuwe faciliteiten bouwt om de productie verder op te voeren. Dat vertaalt zich in het lopende jaar waarschijnlijk in een omzetgroei van 20%. De winst per aandeel kan ruimschoots verdubbelen tot ruim 50 eurocent per aandeel en de sterke pijplijn betekenen dat de winst de komende jaren door blijft groeien. In het huidige onzekere beursklimaat maakt dat Crucell tot een aantrekkelijk aandeel. Het koersdoel voor de lange termijn komt op 20 euro.
  11. [verwijderd] 8 juli 2009 23:47
    Denk dat ze die 10 miljoen hier vandaan halen:

    Van Crucell website

    In December 2007, Crucell and sanofi pasteur signed an exclusive collaboration and commercialization agreement for Crucell's rabies monoclonal antibodies, next-generation rabies biologicals, to be used with rabies vaccine for post-exposure prophylaxis against this fatal disease. Under the terms of the agreement, Crucell will continue to perform the development activities. Crucell will be responsible for the manufacturing of the final product and will retain exclusive distribution rights in Europe, co-exclusive distribution rights in China and the rights to sell to supranational organizations such as UNICEF. Crucell received an initial payment of €10 million following the execution of the agreement and will be eligible for milestone payments of up to €66.5 million.
  12. flosz 28 juli 2009 20:51
    Yeasts Will Save From Rabies
    July 28, 2009
    Experts consider rabies to be almost irremediable, killing up to 50 000 people every year. Unfortunately, Russia is not an exception.
    Russian scientists from Research Centre of Molecular Diagnostics and Treatment started development of first domestic rabies treatment. Authors expect genetically modified yeasts to help them in their struggle in the form of producing therapeutic antibodies. The only one existing method for curing rabies today is treating a patient with therapeutic antibodies, also known as antirabic immunoglobulins. These antibodies are special proteins, which appear in an organism as a reaction on alien substances (rabies agents, in particular), which enter this organism, and neutralize their harmful effect. When a human being gets infected by rabies, the virus, which first gets into blood, gets inside cells of central nervous system before the organism manages to produce its own antibodies. Antibodies are unable to follow the virus to the nervous cells and kill it there, that is why urgent injection of ready-made antibodies is required.
    Until recently anti-rabies agents were produced from purification of immunoglobulins, which were extracted from horse blood serum, but sometimes such agents are not effective enough. This is the reason why ambitious Russian researchers plan their first step towards development of Russian rabies treatment, which is based upon so-called humanized antibodies. Scientists have strong intention to partly modify genotype of antibodies, extracted from mice, by introducing genetic constructions, which are common for human beings. Moreover, scientists claim that new treatment will have reasonable price, since it will be synthesized by means of genetically modified yeasts. The project also includes development of technology for full cycle production of therapeutic antibodies from genetically modified yeasts, which will become a foundation for commercial production of a new treating agent.
    A notable fact is that Russian scientists investigate therapeutic antibodies for about 30 years, however, not a single Russian drug, based upon said antibodies, is listed among over twenty such drugs, which are allowed for use all over the world.

    As for humanized antibodies, the world already knows at least one drug, based on CR4098 antibody, which was developed in the Crucell company of Netherlands. This drug currently undergoes first stage of clinical trials. In theory, Russian pharmaceutical companies could have bought the license to produce the drug abroad, but, according Russian experts, such contracts usually reach $200 million, which is close to annual turnover of leading domestic pharmaceutical corporations. Therefore, researchers consider creating domestic rabies treatment to be the only alternative to importing such drugs from abroad. The project, which is financially supported by the Russian government with about $400 thousand, is expected to last till September 2010.

    www.russia-ic.com/education_science/s...
  13. [verwijderd] 28 juli 2009 23:53
    quote:

    flosz schreef:

    Yeasts Will Save From Rabies
    July 28, 2009
    Experts consider rabies to be almost irremediable, killing up to 50 000 people every year. Unfortunately, Russia is not an exception.
    Russian scientists from Research Centre of Molecular Diagnostics and Treatment started development of first domestic rabies treatment. Authors expect genetically modified yeasts to help them in their struggle in the form of producing therapeutic antibodies. The only one existing method for curing rabies today is treating a patient with therapeutic antibodies, also known as antirabic immunoglobulins. These antibodies are special proteins, which appear in an organism as a reaction on alien substances (rabies agents, in particular), which enter this organism, and neutralize their harmful effect. When a human being gets infected by rabies, the virus, which first gets into blood, gets inside cells of central nervous system before the organism manages to produce its own antibodies. Antibodies are unable to follow the virus to the nervous cells and kill it there, that is why urgent injection of ready-made antibodies is required.
    Until recently anti-rabies agents were produced from purification of immunoglobulins, which were extracted from horse blood serum, but sometimes such agents are not effective enough. This is the reason why ambitious Russian researchers plan their first step towards development of Russian rabies treatment, which is based upon so-called humanized antibodies. Scientists have strong intention to partly modify genotype of antibodies, extracted from mice, by introducing genetic constructions, which are common for human beings. Moreover, scientists claim that new treatment will have reasonable price, since it will be synthesized by means of genetically modified yeasts. The project also includes development of technology for full cycle production of therapeutic antibodies from genetically modified yeasts, which will become a foundation for commercial production of a new treating agent.
    A notable fact is that Russian scientists investigate therapeutic antibodies for about 30 years, however, not a single Russian drug, based upon said antibodies, is listed among over twenty such drugs, which are allowed for use all over the world.

    As for humanized antibodies, the world already knows at least one drug, based on CR4098 antibody, which was developed in the Crucell company of Netherlands. This drug currently undergoes first stage of clinical trials. In theory, Russian pharmaceutical companies could have bought the license to produce the drug abroad, but, according Russian experts, such contracts usually reach $200 million, which is close to annual turnover of leading domestic pharmaceutical corporations. Therefore, researchers consider creating domestic rabies treatment to be the only alternative to importing such drugs from abroad. The project, which is financially supported by the Russian government with about $400 thousand, is expected to last till September 2010.

    www.russia-ic.com/education_science/s...

    Het zoveelste voorbeeld van gemiste kansen .
    Het wordt echt tijd dat politiek en geografische ligging ondergeschikt gaan worden aan wat mensen ECHT nodig hebben ter plaatse.

  14. flosz 7 oktober 2009 08:02
    Positive Results of Phase II Rabies Monoclonal Antibody Combination Clinical Study in Philippines

    Detailed results of this study will be presented at the XX Rabies in the Americas RITA conference in Quebec, Canada on 18-23 October 2009.
    www.rita2009.org/index.html

    Van de Sanofi-site:
    "Rabies, 120 years after Pasteur"
    www.youtube.com/watch?v=mV6ZKIDO9DU

    Sanofi Pasteur and ARC partner on rabies advocacy and educational awareness programs to help reduce human suffering from the disease.
    198.73.159.214/sanofi-pasteur2/ImageS...
    (Zie ook post go: www.iex.nl/forum/topic.asp?forum=228&... )
  15. [verwijderd] 7 oktober 2009 08:57
    quote:

    bionerd schreef:

    Kan Sanofi dit projekt ook nog vertragen net als het griepvirus projekt?
    Als ze dat zouden doen dan kweken ze zoveel "bad-will" bij instanties waar ze mee moeten samenwerken, dat ze dat wel uit hun hoofd zullen laten. Er zijn daar namelijk ook nog mensen die gezondheid van mensen belangrijk vinden. Het is zakelijk een verstandige move om die te vriend te houden!

    Bij griep is het gevecht tussen eitjes en cellen niet van wezenlijke invloed op het vermogen mensen wel/niet te genezen (een te late reactie op een pandemie door te trage productie op eitjes daargelaten).
  16. bionerd 7 oktober 2009 11:13
    In de laatst gegeven investor update van Crucell wordt vermeld dat 20% van 66 mln aan milestone payments voor rabies is ontvangen. Hiervan was 10 mln upfront. Nu fase II bijna is afgerond, zou het niet tijd worden voor een grote milestone payment. Heeft iemand inzicht welke betaling gaat plaatsvinden op welk moment?
90 Posts
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