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Draadje Rabies.

90 Posts
Pagina: 1 2 3 4 5 »» | Laatste | Omlaag ↓
  1. flosz 1 maart 2008 13:44
    Nieuwe start, aanvullingen zijn zeer welkom.

    ABOUT RABIES FEBRUARY 2008
    Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal. The virus infects the central nervous system, causing encephalitis (inflammation of the brain) and ultimately death if medical intervention is not sought promptly after exposure.

    Morbidity and Mortality
    Globally, approximately 10 million people a year are vaccinated after exposure to rabies. Some 40,000 to 70,000 people are thought to die of the disease each year, mainly in Asia and Africa.

    Geographical Distribution
    Rabies is prevalent in all the continental regions of Asia, America and Africa. Greenland and countries in Eastern Europe also have rabies in their animal populations. Wildlife vaccination campaigns have eliminated rabies from terrestrial wildlife in Western European countries. Greenland and Eastern European countries still have a low incidence of rabies cases per year. Recently, bat rabies has emerged as an important epidemiological reservoir in some parts of the world (i.e. the Americas and Australia).

    Transmission
    Transmission of rabies usually takes place when infected saliva is passed to an uninfected animal. Various routes of transmission can occur but the most common mode of transmission is through the bite of a rabid animal. Following infection, the rabies virus spreads through the nerves of the infected animal to the spinal cord and brain. The incubation period after a bite can range from approximately one to three months, although this period may be shorter or extend up to one year. When the virus enters the brain it multiplies rapidly and passes to the salivary glands. During this stage, the classical behavioural changes associated with rabies develop. Death usually occurs within weeks of the person/animal becoming sick.

    Symptoms
    The first symptoms of rabies are usually non-specific and may have symptoms associated with the respiratory, gastrointestinal and/or central nervous system. Symptoms can progress to hyperactivity (furious rabies) or paralysis (dumb rabies). In both cases, paralysis eventually progresses to complete paralysis followed by coma and death in all cases.

    Treatment and Prevention
    There is no treatment for rabies once symptoms of the disease have appeared. However, people who may possibly have been exposed to a rabid animal via a bite or any possible contamination of mucous membranes with infectious material such as saliva can seek post-exposure prophylaxis (PEP) treatment. PEP classically consists of a regimen of one dose of rabies immune globulin (RIG) and five doses of rabies vaccine over a 28-day period, commencing as soon as possible after exposure. While neither vaccine nor antibody is fully efficacious independent of the other, this combined treatment is invariably effective, provided it is administered within 24-48 hours following exposure.
    However, it is widely recognized that there is a need to replace RIG in rabies PEP. Both Human rabies immune globulin (HRIG), as well as equine rabies immune globulin (ERIG), are limited in supply, especially in Asian countries where rabies is a common threat. HRIG and ERIG also present potential safety concerns because they originate from human or equine serum.
    www.crucell.com/page/downloads/Factsh...
  2. flosz 1 maart 2008 13:47
    Crucell Enters Agreement with Sanofi Pasteur for Next-generation Biologicals against Rabies

    Exclusive agreement for rabies monoclonal antibodies to fight fatal disease

    Leiden, The Netherlands, 3 January 2008 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced that it has signed an exclusive collaboration and commercialization agreement with sanofi pasteur, the vaccines division of sanofi-aventis Group, for Crucell's rabies monoclonal antibodies, the next-generation rabies biologicals to be used in association 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 will receive a payment of € 10 million following the execution of the agreement, will be eligible for milestone payments of up to € 66.5 million and will receive an undisclosed percentage on sales of the final product by sanofi pasteur.
    Crucell has developed a combination of two rabies monoclonal antibodies that has shown favorable results comparable to current immunoglobulin products. Phase I clinical trials demonstrated that the antibody product is well tolerated, provides the expected immediate passive neutralizing activity and that it can be safely administered in combination with a rabies vaccine without interfering with the vaccine's ability to induce an active immunity. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. Crucell expects to enter phase II clinical trials in the first half of 2008. Peak sales for Crucell's rabies antibody cocktail are expected to exceed US$ 300 million.
    www.iex.nl/forum/topic.asp?forum=228&...

    Crucell Presents Indian Phase I Rabies Antibody Cocktail Study, Positive Results Enable Prompt Progression Towards Phase II Studies
    Leiden, The Netherlands, 30 November 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced the results of the second clinical evaluation of their rabies monoclonal antibody cocktail. Data for the Phase Ib study conducted in India which started in April 2007 indicate that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be safely administered in combination with a rabies vaccine. The results are presented today, by Dr. Christophe Python, at the Joint International Tropical Medicine Meeting 2007 in Bangkok, Thailand.
    www.iex.nl/forum/topic.asp?forum=228&...

    Published: 08:00 13.11.2007 GMT+1 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562
    Crucell's Rabies Antibody Cocktail Granted Fast Track Status
    Leiden, The Netherlands, 13 November 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL, Swiss Exchange: CRX) today announced that it has been notified by the Food and Drug Administration's (FDA) Department of Health and Human Services that its rabies monoclonal antibody cocktail has been granted a Fast Track designation.

    On 3 October 2007 Crucell presented the results of the first clinical evaluation of the rabies cocktail at the XVIII Rabies in the Americas RITA conference in Mexico. This first-in-man phase I study, which was conducted in the US and started in January 2007, indicates that the cocktail is well tolerated, that it provides the expected neutralizing activity and that it can be safely co-administered in combination with a standard rabies vaccine.
    www.iex.nl/forum/topic.asp?forum=228&...
    www.iex.nl/forum/topic.asp?forum=228&...

    Leiden, The Netherlands, October 3, 2007 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced the results of the first clinical evaluation of the Rabies monoclonal antibody cocktail, a combination of two human monoclonal antibodies.
    Data from the First-in-Man Phase I study conducted in the US indicates that the cocktail is well tolerated, provides the expected neutralizing activity and that it can be administered in combination with rabies vaccine. Crucell is developing this human monoclonal antibody cocktail for the post-exposure prophylaxis of rabies, using its MAbstract® and PER.C6® technologies.
    www.iex.nl/forum/topic.asp?forum=228&...
  3. flosz 1 maart 2008 13:49
    Art. & uitleg van Biocon :

    Journal of Virology, July 2005, p. 9062-9068, Vol. 79, No. 14

    Novel Human Monoclonal Antibody Combination Effectively Neutralizing Natural Rabies Virus Variants and Individual In Vitro Escape Mutants

    Alexander B. H. Bakker,1 Wilfred E. Marissen,1, R. Arjen Kramer,1 Amy B. Rice,2 William C. Weldon,3 Michael Niezgoda,3 Cathleen A. Hanlon,3 Sandra Thijsse,1 Harold H. J. Backus,1 John de Kruif,1 Bernhard Dietzschold,2 Charles E. Rupprecht,3 and Jaap Goudsmit1*

    Crucell Holland BV, Leiden, The Netherlands,1 Department of Microbiology and Immunology, Thomas Jefferson University, Philadelphia, Pennsylvania,2 Centers for Disease Control and Prevention, Division of Viral and Rickettsial Diseases, Rabies Section, Atlanta, Georgia3

    Received 16 February 2005/ Accepted 1 April 2005

    The need to replace rabies immune globulin (RIG) as an essential component of rabies postexposure prophylaxis is widely acknowledged. We set out to discover a unique combination of human monoclonal antibodies (MAbs) able to replace RIG. Stringent criteria concerning neutralizing potency, affinity, breadth of neutralization, and coverage of natural rabies virus (RV) isolates and in vitro escape mutants were set for each individual antibody, and the complementarities of the two MAbs were defined at the onset. First, we identified and characterized one human MAb (CR57) with high in vitro and in vivo neutralizing potency and a broad neutralization spectrum. The linear antibody binding site was mapped on the RV glycoprotein as antigenic site I by characterizing CR57 escape mutants. Secondly, we selected using phage display a complementing antibody (CR4098) that recognized a distinct, nonoverlapping epitope (antigenic site III), showed similar neutralizing potency and breadth as CR57, and neutralized CR57 escape mutants. Reciprocally, CR57 neutralized RV variants escaping CR4098. Analysis of glycoprotein sequences of natural RV isolates revealed that the majority of strains contain both intact epitopes, and the few remaining strains contain at least one of the two. In vitro exposure of RV to the combination of CR57 and CR4098 yielded no escape mutants. In conclusion, a novel combination of human MAbs was discovered suitable to replace RIG.

    Tot nu toe worden personen die een beet hebben gekregen en geïnfecteerd zijn met het rabiës virus behandeld met een combinatie van een rabiës vaccin en anti-rabiës antilichamen. Dit heet dan postexposure prophylaxis (PEP). Voor het antilichaam gedeelte wordt nu gebruikt gemaakt van immunoglubulinen die afkomstig zijn van rabiës gevaccineerde personen of paarden. Deze antilichamen zijn toe aan verbetering. Er zijn al antilichamen aangetoond dat ze muizen bescherming bieden tegen rabiës.
    Crucell heeft nu deze antilichamen aangepast voor productie op PerC6. Toen bleek dat de bestaande 3 antilichamen niet optimaal waren om in combinatie te gebruiken omdat ze hetzelfde gebied (epitope) op het rabiës virus herkennen en dus geen extra bescherming bieden. Mbv Mabstract en de phage display technologie is een nieuwe serie antilichamen tegen rabiës virus gemaakt met banken antilichamen afkomstig uit met rabiës gevaccineerde personen (Zie ook het eerder artikel van Kramer et al). Uit dit grote aantal is er een geselecteerd die samen met een van de al bekende antilichamen uit de bestaande cocktail (maar nu geschikt voor PerC6 productie) de meest optimale combinatie geeft voor PEP.
    In het artikel beschrijven ze de weg van selectie. Er moet een grote neutraliserende werking van het antilichaam zijn, een ander epitoop dan het oorspronkelijke antilichaam moet herkend worden, en de breedste neutraliserende activiteit is wenselijk(er is getest tegen 30 rabiës virus varianten). Tenslotte is in een syrische hamster gekeken naar de werking van de antilichamen, die 24 uur na een dodelijke dosis virus werden toegediend, alleen, samen of in combinatie met het bestaande vaccin en de bestaande antilichaam cocktail. De resultaten laten zien dat elk van de antilichamen afzonderlijk al dezelfde overleving geven (80-100%) als het bestaande vaccin.
    Het mechanisme van de werking is nog niet bekend, maar hoogst waarschijnlijk komt dit doordat de antilichamen het virus binden en daarmee voorkomen dat ze aan de receptor op cellen binden en dus de cellen niet kunnen infecteren.

    De voordelen zijn duidelijk. De nieuwe antilichamen kunnen op PerC6 geproduceerd worden en hoeven niet meer uit bloed van (mogelijk besmette) donoren geïsoleerd worden. Dit betekent schonere antilichamen in grotere hoeveelheden die goedkoper geproduceerd kunnen worden. Kortom, een schijnbaar uitstekende vervanging van de huidige antilichaam cocktail in de behandeling van rabiës infectie.
    www.iex.nl/forum/topic.asp?forum=228&...

    A phase I study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
    www.controlled-trials.com/mrct/trial/...

    A phase Ib study to assess safety and tolerability and neutralising activity of CL184 in healthy volunteers
    www.controlled-trials.com/ISRCTN12693237

    Rabies: 8 million cases, 60 thousand deaths each year
    www.nowpublic.com/rabies-8-million-ca...
  4. flosz 1 maart 2008 13:51

    Crucell presents Phase I results rabies antibody cocktail showing safety and ability to protect
    hugin.info/132631/R/1157802/223783.pdf
    DSM Biologics and Crucell Sign a Biopharmaceutical Manufacturing Agreement

    Parsippany, USA, 03-Oct-2007

    DSM Biologics, a business unit of DSM Pharmaceutical Products (headquartered in Parsippany, NJ) and Crucell (headquartered in Leiden, Netherlands) have signed a Biopharmaceutical Manufacturing Agreement for production on the basis of the PER.C6® manufacturing platform of Crucell’s proprietary antibody cocktail (containing two antibodies), which Crucell develops against rabies. Under the terms of the agreement, Crucell has contracted DSM Biologics, its alliance partner for the PER.C6® manufacturing platform, for the process validation and manufacturing of antibody batches for Phase III clinical efficacy studies. The services will be provided out of DSM Biologics’ FDA-approved manufacturing facility in Groningen, The Netherlands.
    www.dsm.com/en_US/html/dpp/news_items...

    Presentation of the Phase Ib Rabies study by Christophe Python at the Joint International Tropical Medicine Meeting in Bangkok
    www.crucell.com/page/downloads/JITMM_...

    The Lancet Infectious Diseases 2008; 8:12
    DOI:10.1016/S1473-3099(07)70302-X

    Rabies: a preventable killer
    International researchers recently announced successful results from two phase I trials of a human monoclonal antibody cocktail for human rabies post-exposure prophylaxis. CL184, a mixture of two human monoclonals each directed against a distinct, non-overlapping rabies virus epitope, was well tolerated and had neutralising activity when given alone or in combination with rabies vaccine. According to Charles Rupprecht, rabies control expert at the Centers for Disease Control and Prevention (Atlanta, GA, USA), “this is one of the most important advances in human rabies post-exposure prophylaxis in the past 30 years”.
    If left untreated, the bite of a rabid animal leads to acute encephalitis, which progresses to coma and death within a few weeks. Modern and effective prophylaxis entails immediate wound care, local infiltration of rabies immune globulin, and parenteral administration of modern cell culture vaccines in multiple doses over a 28-day period. However, supply of immune globulin to regions of Asia and Africa, where rabies kills at least 55 000 people per year, most of them children under 15 years of age, is patchy at best. “Producing the antibodies in sufficient quantities is problematic and, with plasma products such as these there's always some risk of transmitting infections such as HIV/AIDS, hepatitis, and variant Creutzfeldt-Jakob disease”, explained Lex Bakker of Crucell (Leiden, Netherlands). “Both of these issues would be solved by a human monoclonal preparation”, said Rupprecht.
    crucell.yourbb.nl/viewtopic.php?f=7&t...

    12-02-2008:Rabies Phase II, about to start….(Q&A, Ken..van Fortis) USA/ Philipijnen.., patienten ontvangen eerste prik dit kwartaal(in US)!
    webcastingplayer.corporate-ir.net/PLA...

    Crucell & Sanofi Pasteur sign exclusive collaboration and commercialization agreement for rabies monoclonal antibodies
    • Results of two Phase I studies with rabies monoclonal antibody cocktail (two antibodies), showing safety and ability to protect
    • Fast Track status for rabies monoclonal antibody cocktail

    Crucell & Sanofi Pasteur (Jan.’08)

    Exclusive collaboration and commercialization agreement for Crucell's rabies monoclonal antibodies
    Crucell will receive milestone payments of up to €66.5 million
    Partnership sanofi pasteur
    • Estimated market opportunity of peak annual sales exceeding $300 million
    • 40.000 - 60.000 annual deaths
    • Safe and efficacious rabies immunoglobulin often not available to the people in need
    • Current human serum-based treatment under scrutiny due to adventitious agents (HIV, hepatitis, vCJD)
    library.corporate-ir.net/library/12/1...
  5. flosz 11 april 2008 08:47
    Crucell Announces Start of Phase II Clinical Study Rabies Monoclonal Antibody Combination in US

    First Milestone Achieved in Collaboration Agreement with Sanofi Pasteur

    Leiden, The Netherlands, 31 March 2008 - Dutch biotechnology company Crucell N.V. today announced that its rabies monoclonal antibody combination has entered a Phase II clinical trial in the United States. At the beginning of the year, Crucell announced it had signed 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 combination with sanofi pasteur rabies vaccine for post-exposure prophylaxis against this fatal disease. The start of the Phase II study constitutes the first milestone in this agreement.

    The clinical trial will be a randomized, single-blind, controlled study in 140 healthy volunteers that will test the antibody product in association with sanofi pasteur rabies vaccine and compare it to the currently marketed human rabies immune globulin or placebo, in association with rabies vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.

    "We are very pleased with our continued and rapid progress with this next generation rabies treatment," said Ronald Brus, Crucell's Chief Executive Officer. "The swift development of this rabies monoclonal antibody product would be extremely valuable in reducing the global burden of this fatal disease."

    Sanofi Pasteur is the worldwide market leader in providing biologicals for pre- and post-exposure prophylaxis against rabies. In the last 20 years, over 20 million people in 100 countries have been treated with sanofi pasteur's rabies products.
    www.iex.nl/forum/topic.asp?forum=228&...

    Presentatie (12-03-2008) Lex Bakker….een MUST!

    www.crucell.com/page/downloads/7_Lex_...

    www.thomson-webcast.net/uk/dispatchin...
  6. flosz 11 april 2008 08:49
    Art. uit Vaste Prik nr. 5.
    Rabiës vereist snelle actie.

    Onlangs overleed een 34-jarige Nederlandse
    vrouw aan hondsdolheid (rabiës) nadat ze
    in Kenia door een vleermuis was besmet.
    Hondsdolheid komt wereldwijd voor maar
    is in ons land een zeldzaam verschijnsel. Wie
    niet tijdig behandeld wordt, gaat dood.
    De jonge vrouw werd eind oktober 2007 op een camping
    in Nairobi tijdens het tandenpoetsen door een vleermuis op
    haar neus gekrabd. Ze maakte de wond schoon met zeep en
    alcohol.
    Vaccinaties tegen hondsdolheid hadden haar leven kunnen
    redden maar de campingbeheerder en het dichtstbijzijnde medische
    centrum wisten niet dat rabiës voorkwam bij de vleermuizen
    in hun streek. Zij adviseerden geen verdere actie. De
    vrouw en haar man vervolgden hun vakantie. Op 19 november
    werd de vrouw met spraakstoornissen en een afgenomen gevoel
    in beide wangen opgenomen in het Academisch Medisch
    Centrum te Amsterdam. Daar werd de diagnose gesteld: rabiës.
    Voor succesvolle behandeling was het te laat. De vrouw
    overleed op 8 december.

    Verspreiding en besmetting
    Hondsdolheid is in Nederland een zeldzame aandoening. In
    1962 was de laatste ‘uitbraak’ van rabiës waarbij vijf mensen
    overleden na de beet van een zieke hond. Naar aanleiding
    hiervan kwam er een vaccinatiecampagne voor honden die
    duurde tot 1965. Tegenwoordig moeten honden en katten die
    de grens overgaan, gevaccineerd zijn tegen rabiës.
    Rabiës wordt veroorzaakt door een virus dat bij zoogdieren
    voorkomt. Het klassieke rabiësvirus komt wereldwijd
    voor. In landen zoals India en Sri Lanka, maar ook in Marokko
    en Turkije circuleert het veelvuldig onder honden en
    katten. Het komt echter ook voor bij in het wild levende
    dieren. In Europa zijn de vos, de wasbeer en de vleermuis
    de voornaamste verspreiders. Er zijn verschillende typen
    van het rabiësvirus die bijna allemaal besmettelijk zijn voor
    mensen. Driekwart van de mensen die rabiës oplopen,
    krijgt de infectie door hondenbeten. De kans op besmetting
    bij een beet door een hondsdolle hond is 20 procent.
    Zonder behandeling, is de afloop in alle gevallen dodelijk.
    Jaarlijks sterven ten minste 55.000 mensen aan rabiës,
    van wie de meeste in India.
    Het virus wordt door besmette dieren uitgescheiden in het
    speeksel en overgebracht door bijten, krabben of likken.
    Via de slijmvliezen of huidwondjes kan het virus binnendringen.
    Op de plek waar het virus binnen komt vermenigvuldigt
    het zich eerst in de spieren en gaat dan via het
    zenuwstelsel naar de hersenen.
    Besmette vleermuizen
    In Europa hebben vleermuisbeten en -krabben enkele
    mensenlevens geëist. Deze vleermuizen waren besmet
    met een aan het klassieke rabiësvirus verwant virus, het
    European Bat Lyssavirus (EBLV). Vooral de laatvlieger en
    in mindere mate de meervleermuis kunnen deze virussen
    bij zich dragen. In Nederland is in 1987 de eerste
    besmette vleermuis ontdekt. Uit recent onderzoek blijkt
    dat circa 21 procent van de laatvliegers en 4 procent
    van de meervleermuizen dit virus bij zich draagt. Bij de
    meest voorkomende vleermuis in Nederland – de gewone
    dwergvleermuis – is het virus nog nooit gevonden.

    Furieus
    De incubatieperiode varieert van enkele dagen tot een jaar
    (gemiddeld 20 tot 60 dagen) en is sterk afhankelijk van de
    plek van de beet. Hoe dichter bij het centrale zenuwstelsel,
    hoe korter de incubatietijd. De ziekte kan zich uiten
    in een ‘furieuze vorm’ of een ‘paralytische vorm’ met een
    toenemende verlamming. De eerste ziekteverschijnselen
    zijn jeuk op de plek van de beet, koorts en uitval van spieren,
    verminderde eetlust, misselijkheid, braken en hoofdpijn.
    Later treden zenuwverschijnselen op als krampen of
    verlammingen, nekstijfheid, hyperactiviteit en stuipen. Bij
    ongeveer de helft van de mensen treden spasmen op van
    de slik- en halsspieren wanneer water of speeksel weggeslikt
    moet worden. Mensen krijgen dan watervrees.
    Samen met een verhoogde speekselvloed leidt dat tot
    schuimvorming op de mond. In een verder stadium treedt
    coma op, leidend tot de dood door ademhalingsstilstand
    en hartproblemen.
    Bij het dier gaat de ziekte gepaard met dezelfde verschijnselen
    als bij de mens. Gedragsverandering is één van de
    eerste symptomen. Honden en katten laten vooral de ‘furieuze
    vorm’ zien en vee de ‘paralytische vorm’.
    Snelle actie
    Infectie met rabiës kan worden voorkomen door vaccinatie. In Nederland
    wordt een geïnactiveerd rabiësvirus gebruikt. Reizigers naar landen
    waar hondsdolheid endemisch is, zoals Turkije, Marokko en India,
    komen in bepaalde gevallen in aanmerking voor vaccinatie. Wie ‘wild’
    gaat reizen in deze gebieden moet vaccinatie serieus overwegen. Voor
    werknemers die regelmatig met vleermuizen in contact komen, is preventieve
    vaccinatie een must. Dat geldt niet alleen voor onderzoekers
    en verzorgers die beroepshalve in laboratoria en dierentuinen met
    deze dieren in aanraking komen, maar ook voor vrijwilligers die actief
    zijn bij vleermuisgroepen.
    Effectieve postexpositiebehandeling is mogelijk bij rabiës. Die moet
    zo snel mogelijk na een mogelijke besmetting starten en bestaat uit
    een combinatie van passieve immunisatie (immunoglobulinen) en
    actieve immunisatie (vijf inentingen met rabiësvaccin). Ook degene
    die al gevaccineerd is, moet zich na mogelijk contact met een besmet
    dier zo snel mogelijk melden voor behandeling. Het voorbeeld van de
    onlangs overleden vrouw maakt duidelijk dat wie in een vreemd land
    een beet(of krab) van een dier krijgt er altijd goed aan doet contact op
    te nemen met de GGD in Nederland of met het Centrum Infectieziektebestrijding.
    Daar weet men precies hoe te handelen.

    Rabiësrichtlijn CIb:
    www.rivm.nl/cib/infectieziekten/
    rabies(virus)/Rabies_hondsdolheid.
    Jsp

    Over actuele verspreiding van
    rabiës:
    www.who-rabies-bulletin.org
    www.who.int/rabies

    Bronnen:
    RIVM/Centrum Infectieziektebestrijding
    Centraal Veterinair Instituut Wageningen UR
    www.rivm.nl/cib/binaries/Vaste%20Prik...

    Wat te doen bij vermoeden van
    rabiësbesmetting?
    Mensen die vanwege hun beroep of door reizen in het buitenland
    een grote kans hebben om in contact te komen
    met dieren, zoals honden, katten, vossen of vleermuizen,
    kunnen zich laten vaccineren tegen rabiës. Zij krijgen dan
    profylactisch driemaal 1 ml rabiësvaccin intramusculair geïnjecteerd. Mensen die gebeten, gekrabd of gelikt zijn
    door een van rabiësverdacht dier, moeten zo snel mogelijk
    contact opnemen met GGD of huisarts. De GGD overlegt
    in de regel met het RIVM (CIb) over het te volgen behandelbeleid.
    De postexpositiebehandeling bestaat uit immunoglobuline
    (MARIG) in combinatie met rabiësvaccin.
    Soms ook alleen uit rabiësvaccin. Dit vaccin wordt gegeven
    in een schema van vijf intramusculaire injecties op
    dag 0, 3, 7, 14 en 28 na de beet (WHO-Essenschema).
    Bijlage:
  7. [verwijderd] 16 april 2008 13:48
    A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects

    This study is currently recruiting participants.
    Verified by Crucell Holland BV, April 2008

    Estimated Enrollment: 140
    Study Start Date: March 2008
    Estimated Study Completion Date: July 2008
    Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

    clinicaltrials.gov/ct2/show/NCT006560...
  8. flosz 13 mei 2008 08:12
    Start of Phase II Clinical Study for Rabies Monoclonal Antibody Combination in the Philippines

    Leiden, The Netherlands, 13 May 2008 - Dutch biotechnology company Crucell N.V. today announced that its rabies monoclonal antibody combination product has entered a second phase II clinical study in the Philippines. On 31 March 2008 the company announced the start of a first phase II clinical study in the U.S.

    At the beginning of the year, Crucell announced a collaboration and commercialization agreement with sanofi pasteur for Crucell's rabies monoclonal antibody combination product to be used in combination with rabies vaccines for post-exposure prophylaxis against this fatal disease. 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. The first phase II study, as announced in March 2008, marked an important milestone in the collaboration agreement.

    The second phase II clinical trial will be a randomized, single-blind, controlled study in 48 healthy adolescents and children. The study will test the rabies monoclonal antibody combination product in association with sanofi pasteur's rabies vaccine and will compare it to the human rabies immune globulin, which is currently administered with the vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity. This clinical trial aims to generate safety data in children in Asia, complementing the safety data generated in adult volunteers during a phase I trial conducted in India. Jointly, the combined data allows a swift phase III clinical evaluation of the monoclonal antibody combination in individuals exposed to rabies in endemic areas like Asia.

    "We are clearly on a fast track with the development of this new rabies treatment", said Ronald Brus, Crucell's Chief Executive Officer. "Our rabies antibody combination product is highly suitable to replace the currently used serum-based products. This antibody product can be produced in sufficient quantities to cover public and private sectors needs by the use of our PER.C6® technology. Expanded product availability would clearly help combat the supply restrictions of serum-based immune globulin products. The continued rapid development of our rabies antibody product in combination with sanofi pasteur's rabies vaccine can therefore considerably reduce the global burden of this fatal disease. "

    Sanofi pasteur is the worldwide market leader in providing biologicals for pre- and post-exposure prophylaxis against rabies. In the last 20 years, over 20 million people in 100 countries have been treated with sanofi pasteur's rabies products.

    Peak sales for Crucell's rabies monoclonal antibody combination product are expected to exceed US$ 300 million.
  9. flosz 24 juni 2008 16:15
    LIQUID ANTI-RABIES ANTIBODY FORMULATIONS

    Publication number: WO2008068246
    Publication date: 2008-06-12
    Inventor: BAKKER ALEXANDER BERTHOLD HEND (NL); MARISSEN WILLEM EGBERT (NL)
    Applicant: CRUCELL HOLLAND BV (NL); BAKKER ALEXANDER BERTHOLD HEND (NL); MARISSEN WILLEM EGBERT (NL)
    Classification:
    - international: A61K9/00; C07K16/00; A61K9/00; C07K16/00;
    - European:

    Application number: WO2007EP63244 20071204
    Priority number(s): US20060872892P 20061205; EP20060125400 20061205

    Abstract of WO2008068246
    The present invention provides pharmaceutical antibody formulations, in particular liquid pharmaceutical formulations comprising anti-rabies virus antibodies. The formulations can be used in the post exposure prophylaxis of rabies.
    v3.espacenet.com/textdes?DB=EPODOC&ID...
  10. flosz 25 juni 2008 19:53
    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...
  14. [verwijderd] 25 september 2008 14:57
    WHO recognises Vietnam’s efforts to wipe out rabies

    25/09/2008 -- 6:45 PM

    Hanoi (VNA) – Vietnam is leading the way in the implementation of ASEAN+3’s initiatives to eliminate rabies by 2020, a World Health Organisation (WHO) expert said on September 25.

    WHO Country Representative Jean Marc Olive made the remarks at a meeting held in Hanoi by the Health Ministry in response to World Rabies Day (September 28).

    The expert also affirmed that the WHO will work closely with Vietnam to meet this target.

    During the meeting, Deputy Health Minister Trinh Quan Huan stressed the need to increase public awareness of rabies as the disease, though preventably remains a community health problem in Vietnam with 131 people dying from rabies last year.

    The fatalities were 38 for the first eight months of 2008.

    The WHO said that more than 55,000 people die from rabies every year or one death every ten minutes. Children are often at greatest risk from the disease as they are more likely to be bitten by dogs and also more likely to suffer from multiple bites.-Enditem

    www.vnagency.com.vn/Home/EN/tabid/119...
  15. flosz 2 oktober 2008 07:02
    Even plakken, by ivet:
    Published: 21:30 01.10.2008 GMT+2

    Crucell Announces Positive Results of Phase II Clinical Study Rabies Monoclonal Antibody Combination in US
    Additional Milestone Achieved in Collaboration Agreement with sanofi pasteur

    Leiden, The Netherlands, 1 October 2008 - Dutch biopharma company Crucell N.V. today announced the preliminary results of the first phase II clinical study of its investigational rabies monoclonal antibody combination, which started on 31 March 2008 in the US.
    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 combination with rabies vaccine for post-exposure prophylaxis against this fatal disease.
    The preliminary results of the US study were presented today by Dr. Christophe Python, at the XIX Rabies in the Americas RITA conference in Atlanta, U.S.
    This phase II trial was set up as a randomized, single-blind, controlled study in 140 healthy volunteers and tested the antibody product in association with sanofi pasteur human diploid cell rabies vaccine. The study compared the rabies monoclonal antibody combination to a currently marketed human rabies immune globulin or placebo, in association with the rabies vaccine in a simulated rabies post-exposure setting.
    A total of 140 subjects were randomized into the study, 80 in the CL184 monoclonal antibody combination treatment group, 40 in the human rabies immune globulin group and 20 in the placebo group. All subjects completed the study. There was no serious adverse event reported. Most adverse events were mild or moderate in severity. Overall, the systemic safety was comparable in the placebo, the HRIG and the monoclonal antibody combination groups. Injection site reactions to the monoclonal antibody combination, the human rabies immune globulin or placebo were reported by 12.5%, 65 % and 30% of the subjects, respectively.
    The neutralizing activity against the rabies virus (a surrogate marker for protection) provided by the monoclonal antibody combination was comparable to that provided by the comparator. By day 14, all subjects administered the monoclonal antibodies combination together with the rabies vaccine reached the level of 0.5 IU/ml, a neutralizing activity levels thought to provide protection. Of note, the development of the immune response to the rabies vaccine was comparable in the monoclonal antibody combination and the human rabies immune globulin groups. These encouraging preliminary results are paving the way for the further development of this potentially life-saving medicine.

    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). A second phase II clinical study started on May 13, 2008, in the Philippines, and is expected to be completed before year-end 2008. The trial, which is being carried out in 48 healthy adolescents and children, aims to generate safety data in these populations.
    "We are very pleased with our continued and rapid progress with this next generation rabies treatment," said Ronald Brus, Crucell's Chief Executive Officer. "These results and the milestone achieved put us another step closer to our ambition of reducing the global burden of this fatal disease."

    About rabies
    Rabies is a viral disease of mammals most often transmitted through the bite of a rabid animal. The virus infects the central nervous system, causing encephalitis (inflammation of the brain) and ultimately death if medical intervention is not sought promptly after exposure. There is no proven treatment for rabies once symptoms of this fatal disease have appeared. Rabies is prevented by post-exposure prophylaxis (PEP) with the combined administration of a rabies vaccine and rabies immunoglobulin (RIG). Rabies is prevalent in Europe, Asia, Africa, North America and South America. Every year approximately 10 million people are vaccinated against the disease worldwide. An estimated 40,000 to 70,000 people die from rabies each year, mainly in Asia.

    About Crucell's rabies monoclonal antibody program
    Crucell's rabies monoclonal antibody product is a combination of two human monoclonal antibodies, generated using Crucell's MAbstract® technology and produced using Crucell's PER.C6® technology. Crucell's rabies monoclonal antibody combination offers the potential to replace the traditional serum-derived products that are currently used for rabies post-exposure prophylaxis. Phase I clinical trials data conducted in the United States and India supported further clinical development. The program has been granted a Fast Track designation by the Food and Drug Administration's (FDA) Department of Health and Human Services. The Fast Track program facilitates the development and expedites the review of new drugs that are intended to treat serious or life-threatening diseases and that demonstrate the potential to address unmet medical needs.

    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.

    Peak sales for Crucell's rabies antibody combination are expected to exceed $ 300 million.
    www.iex.nl/forum/topic.asp?forum=228&...
  16. flosz 3 oktober 2008 14:19
    Research Morning Note 02-10-08

    Crucell (Buy): Positive Phase II results in Rabies

    The facts: Yesterday, Crucell announced positive preliminary results of its first Phase II clinical trial of its monoclonal antibody combination against rabies. This trial was set up in the US.

    Our analysis: The study started on 31 March 2008 in the US in which 140 healthy volunteers were enrolled. In the study the rabies monoclonal antibody combination of Crucell was compared to a currently marketed human rabies immune globulin from Sanofi Pasteur. There were no serious adverse events reported. The neutralizing activity against the rabies virus that was seen with the monoclonal antibody combination, was comparable to the product of sanofi Pasteur. Currently, Crucell has a collaboration and commercialization agreement with Sanofi Pasteur for the monoclonal antibody combination. Under the agreement, Crucell will be responsible for the manufacturing of the product ans has exclusive distribution rights in Europe, co exclusive rights in China and the rights to sell to supranational organisations like UNICEF. Crucell is entitled to get milestone payments of up to EUR 66.5m.

    Conclusion & Action: We now should wait for the data on the second Phase II trial which was started in the Philippines, which is expected before the end of this year. We expect the start of a Phase III trial beginning of 2009. The company expects to reach peak sales of USD 300m for its product. Especially in developing countries and China we believe that the product can get a high market share because of its low manufacturing cost. Crucell is able to make its product for around USD 20, whereas the current treatment costs more than USD 750. We expect this product to be on the market in 2011.
  19. flosz 10 oktober 2008 23:09
    Alpen - 10 okt 08, 22:54

    Status update 2e deel fase II - sinds enkele dagen worden er geen deelnemers meer gerecruteerd.
    Rekening houdend met de aangegeven 42 dagen IMO goed op schema voor afronding in november.

    clinicaltrials.gov/ct2/show/NCT00708084
    www.iex.nl/forum/topic.asp?forum=228&...
  20. flosz 21 oktober 2008 13:55
    The facility was set up in Ahmedabad in collaboration with S witzerland-based Berna Biotech, the company said.
    ***************************

    Zydus Cadila gets WHO nod for rabies vaccine
    Tuesday, October 14, 2008

    MUMBAI: Drug maker Zydus Cadila on Tuesday said it has received World Health Organisation approval to sell rabies vaccine -- Lyssavac N -- to UN agencies.
    The vaccine would be available to various United Nations agencies and with this Zydus Cadila has become the first Indian company and the second in the world to receive the said approval, Cadila Healthcare said in filing to the Bombay Stock Exchange.
    Cadila Healthcare is the flagship company of Zydus Cadila Group. The group produces three million doses of the vaccine per annum. The vaccine is marketed in India under the brand name Vaxirab. The facility was set up in Ahmedabad in collaboration with S witzerland-based Berna Biotech, the company said.
    The vaccine is currently exported to South Asia and Africa, the filing said.
    Rabies virus infects the central nervous system, causing disease in the brain and subsequently death.
    Shares of the company were trading at Rs 286.50, up 0.23 per cent in the afternoon trade on the BSE. - PTI
    www.thehindubusinessline.com/blnus/02...
    *********************************

    Zydus Cadila launches 'Vaxirab' a new generation rabies vaccine
    Zydus Cadila has launched a Highly, Purified Duck Embryo Rabies Vaccine under the brand name 'Vaxirab'. The vaccine is manufactured in technical collaboration with Berna Biotech of Berne, Switzerland, the originators of this vaccine and also one of the leading vaccine manufacturers in Europe. The international brand 'Lyssavac N Berna' was first registered in Switzerland in 1985 and is currently available in 30 countries world-wide.
    The Purified Duck Embryo Rabies vaccine, which is a new generation rabies vaccine approved by the WHO, offers faster action and quicker protection making it ideal for those dog bite cases where the incubation period is lesser.
    The clinical trials of Vaxirab were conducted at Haffkine's Institute at Mumbai in which very high protective antibody levels were demonstrated in both healthy volunteers and patients with animal bites and no adverse effects were reported in any of the subjects. Unlike other rabies vaccines available in India, Vaxirab does not require any artificial media for propagation of the rabies virus, making it safe with no allergic reactions.

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