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draadje Malaria

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Pagina: «« 1 ... 17 18 19 20 21 22 »» | Laatste | Omlaag ↓
  2. maxen 6 april 2010 21:39
    quote:

    ved schreef:

    Kill It! Double-Teaming Malaria

    By Brian Orelli
    April 6, 2010

    Malaria is one tough cookie......... zie:

    tinyurl.com/ylf4pyk

    Plak hem even in, omdat er duidelijk instaat waarom GSK en Crucell hengelen naar externe financiering:

    Malaria is one tough cookie. There are prophylaxes to prevent infection and other drugs available to treat the infection, but an effective vaccine has largely eluded drugmakers. The lack of an effective vaccine leads to close to 900,000 deaths a year. That's the population of the state of Delaware.

    Rather than fight the microorganism alone, Crucell (Nasdaq: CRXL) and GlaxoSmithKline (NYSE: GSK) decided to team up. A few years ago, the companies announced that they'd test their individual vaccines against one of the parasites that causes malaria to see if combining them elicited a stronger immune response. The results were good enough that the companies announced today that they're extending their partnership and advancing the combination product into the clinic.

    Combining treatments to increase efficacy isn't anything new. Pfizer (NYSE: PFE) and Glaxo have teamed up to develop combo drugs to fight HIV as have Johnson & Johnson (NYSE: JNJ) and Gilead Sciences (Nasdaq: GILD). Merck (NYSE: MRK) and AstraZeneca (NYSE: AZN) have decided to test their individually developed cancer drug candidates together.

    Unlike HIV and cancer, though, the moneymaking opportunity for Crucell and Glaxo is limited because malaria isn't a big problem for countries that can afford high drug prices. The duo will likely have to find a nonprofit or government entity to pony up some cash to fund the large phase 3 trial.

    Developing a malaria vaccine won't get the companies rich, but cutting into the 900,000 annual deaths should give them some positive publicity. Considering the beating the industry has taken due to high health-care costs, investors should welcome the potential public relations bonus.
  3. forum rang 4 aossa 7 april 2010 11:51
    The PATH Malaria Vaccine Initiative congratulates GlaxoSmithKline Biologicals and Crucell on new malaria vaccine collaboration

    April 6, 2010—The PATH Malaria Vaccine Initiative (MVI) today congratulated GlaxoSmithKline Biologicals (GSK Bio) and Crucell NV on their new collaboration to develop a vaccine approach aimed at boosting the efficacy of the world’s most clinically advanced malaria vaccine candidate, RTS,S.

    "We are excited by the potential of this new endeavor for the field of malaria vaccine development overall and very pleased with the way in which the effort announced today aligns with MVI's own research and development strategy," said Dr. Ashley Birkett, director of pre- and early-clinical research and development at MVI. "The agreement between GSK Bio and Crucell is an example of the kind of collaboration that will be required to achieve the community’s goal of a highly effective, next-generation vaccine."

    MVI has strong and successful collaborations with each of the parties to this new agreement. MVI has worked in collaboration with GSK Bio since 2001 and is currently supporting the Phase 3 trial of RTS,S. Under an agreement with Crucell, MVI will support the first test in humans of a vaccine approach that includes weakened cold viruses coupled to a protein similar to that used in RTS,S (Ad35.CS and Ad26.CS). The newly announced collaboration will focus on a "prime-boost" approach, using the Crucell cold virus-derived vaccine candidate (Ad35.CS) as a first dose (prime), followed by two doses of the GSK vaccine candidate (RTS,S) to enhance the body’s ability to fight the parasite.

    "With a first malaria vaccine on the horizon, we need to be thinking about how to prepare for this major breakthrough in the battle against malaria," said Dr. Christian Loucq, director of MVI. "At the same time, this new agreement highlights the importance of investing in the development of next-generation vaccines—including those that build on the success to date of RTS,S—so that we can continue to close in on the elimination of this deadly disease."

    "MVI is committed to attaining a world free from malaria," Dr. Loucq concluded. "We applaud this endeavor between two of our industry partners and hope that it will inspire others to join together in pursuit of ever more effective malaria vaccines."

    www.malariavaccine.org/GSKCrucellAnno...
  4. forum rang 4 aossa 7 april 2010 12:16
    MVI discusses what's on the horizon for malaria vaccine development
    Ashley Birkett, Director of Pre- and Early-Clinical Development discusses the program's strategy to control malaria and eliminate the disease in the long-term

    Q: What is MVI currently working on?

    A: RTS,S, the world's most clinically advanced malaria vaccine candidate, is currently undergoing Phase 3 testing, often the last phase of testing prior to licensure. This is a major achievement in the field of malaria vaccine development, and if all goes well, RTS,S will become the first ever vaccine approved for use against a human parasite. However, we realize more must be done if we hope to achieve the long-term goal of eradication. We are eager to build on the progress of RTS,S in order to develop vaccines that will provide even greater levels of protection against this deadly disease. That is why we are moving ahead with a strategy for developing a next-generation vaccine that includes candidates that can block transmission of the parasite as well as blood-stage and multi-antigen approaches.

    Q: Can you explain MVI's strategy?

    A: A key part of our strategy is to build on previous vaccines successes and failures, particularly those achieved in human clinical studies. The most notable success to date has been achieved with RTS,S, a pre-erythrocytic candidate that aims to protect against the early stage of Plasmodium falciparum malaria infection. This vaccine candidate was found to be 53 percent effective against clinical disease in Phase 2 trials. We’re now testing it in Phase 3 trials at 11 sites in seven African countries.

    At the same time, we're working on approaches that should help us to achieve a 2025 goal set by the malaria community and global health experts. That goal is to develop a product that is at least 80 percent effective against clinical malaria for at least four years.

    Q: How do you plan to achieve the goal of an 80 percent effective vaccine by 2025?

    A: Our strategy is multi-pronged. We plan to focus heavily on pre-erythrocytic vaccine candidates—those that target the parasite on its journey to the liver or as it matures in an infected person's liver cells. There are also exciting new data in the development of blood-stage vaccines that need to be considered, particularly if they can be effectively combined with a pre-erythrocytic approach. Further, we are widening our focus to include transmission-blocking vaccines and are also pursuing candidates that target the less deadly but more widespread P. vivax malaria.

    Q: How have calls for eventual malaria elimination and eradication affected your work?

    A: The malaria community's push toward an elimination and eradication focus led us to reevaluate our research and development strategy. The steps we have taken to further diversify our portfolio of vaccine candidates are a direct response to the new focus on the ultimate goal of ridding the world of this deadly disease. However, it is important to note that eradication is a long-term goal, as opposed to a near term one. Even in the face of an eradication effort, our interactions with experts in the field have emphasized the continued need for us to accelerate the development of vaccines that are highly effective at preventing clinical malaria. It is therefore of utmost importance that we balance our work in these two critical areas to ensure that we most effectively meet the anticipated needs of those affected most by malaria.

    Q: You mentioned transmission-blocking vaccines. How does this type of vaccine work?

    A: To complete its life cycle and reproduce, the malaria parasite must first infect humans and then be transmitted to and infect mosquitoes, a process that is repeated again and again. Transmission-blocking vaccine candidates typically seek to interrupt the life cycle of the parasite by inducing antibodies that prevent the parasite from maturing in the mosquito after it takes blood from a vaccinated person. Over time, this would reduce the number of infected mosquitoes, leading to fewer people becoming infected, which then leads to further reductions in the numbers of infected mosquitoes and so on until the parasite is eventually wiped out—in other words, eradicated.

    Q: How would a transmission-blocking vaccine fit into your overall strategy?

    A: Strictly speaking, a successful transmission-blocking vaccine would not directly protect the individual vaccinated from contracting the disease; it would only impact disease over time by reducing the number of malaria infections in a community. However, we have an increasing interest in multi-stage, multi-antigen vaccines, such that vaccines that prevent disease and transmission could be combined into a single product. Such a combination approach could increase acceptance and therefore deployment and effectiveness of a transmission-blocking vaccine. We believe that a highly effective vaccine that could block the parasite's lifecycle, reduce transmission in endemic areas, as well as provide protection from clinical disease would be a key tool in the global effort to eventually eradicate malaria.

    www.malariavaccine.org/RD_Strategy_QA...
  5. forum rang 4 aossa 8 april 2010 11:53
    April 2010 article from the "Vaccine" journal
    tinyurl.com/yjw2d7d

    Adenovectors induce functional antibodies capable of potent inhibition of blood stage malaria parasite growth

    Joseph T. Brudera,

    Abstract
    An effective malaria vaccine remains a global health priority. Recombinant adenoviruses are a promising vaccine platform, and Plasmodium falciparum apical membrane antigen 1 (AMA1) and merozoite surface protein 1–42 (MSP142) are leading blood stage vaccine candidates. We evaluated the importance of surface antigen localization and glycosylation on the immunogenicity of adenovector delivered AMA1 and MSP142 and assessed the ability of these vaccines to induce functional antibody responses capable of inhibiting parasite growth in vitro. Adenovector delivery induced unprecedented levels of biologically active antibodies in rabbits as indicated by the parasite growth inhibition assay. These responses were as potent as published results using any other vaccine system, including recombinant protein in adjuvant. The cell surface associated and glycosylated forms of AMA1 and MSP142 elicited 99% and 60% inhibition of parasite growth, respectively. Antigens that were expressed at the cell surface and glycosylated were much better than intracellular antigens at inducing antibody responses. Good T cell responses were observed for all forms of AMA1 and MSP142. Antigen-specific antibody responses, but typically not T cell responses, were boosted by a second administration of adenovector. These data highlight the importance of rational vaccine design and support the advancement of adenovector delivery technology for a malaria vaccine.
    ====================
    "How does GNVC's malaria vaccine differ from the ones that GSK is testing?"

    I'm not expert, but I believe Adenovector is a technology that GNVC has patents on, so the GSK technology would be different.

    As I see it, at this point GSK is way behind the 8 ball as they've gone back to the drawing boards to combine what they had in trials with Crucell's trial efforts. Essentially they're creating a new drug, starting nearly from scratch.

    There is a huge difference if you're GSK and announce the failure of a product, or a trial, and if you're a GNVC. In GSK's case they didn't even say the trial failed, just simply that they're moving on. If you're one of the giants, that's how you can do things, you have so many failures there is no need to announce them. Perhaps some day GNVC will be so big that such an announcement will hardly be noticed, but that's not the case today. I can't wait for some day.

    Gary

    www.investorvillage.com/mbthread.asp?...
  6. maxen 8 april 2010 13:01
    quote:

    aossa schreef:

    ...
    There is a huge difference if you're GSK and announce the failure of a product, or a trial, and if you're a GNVC. In GSK's case they didn't even say the trial failed, just simply that they're moving on. If you're one of the giants, that's how you can do things, you have so many failures there is no need to announce them.
    ...
    Crucell rekent zichzelf al duidelijk tot de grote jongens ;-)
  7. maxen 8 april 2010 13:09
    quote:

    aossa schreef:

    ...
    As I see it, at this point GSK is way behind the 8 ball as they've gone back to the drawing boards to combine what they had in trials with Crucell's trial efforts. Essentially they're creating a new drug, starting nearly from scratch.

    There is a huge difference if you're GSK and announce the failure of a product, or a trial, and if you're a GNVC. In GSK's case they didn't even say the trial failed, just simply that they're moving on.
    ...
    Zonder gekheid,
    hier wordt gesuggereerd dat GSK's go-it-alone benadering gefaald heefd, dat de phase III RTS,S trial aan het falen is, dat RTS,S als afzonderlijk vaccin er niet gaat komen, en dat GSK helemaal opnieuw begint samen met Crucell.

    Dat is een radicale interpretatie. Ik persoonlijk schatte in dat GSK gewoon door zou gaan met de phase III RTS,S trial, en zou streven naar marktintroductie ervan, en dat ze later (5-10 jaar later) een NIEUW! en VERBETERD! product zouden offreren m.b.v. Crucell's Ad35 (analoog aan uitbreiding van Prevnar7 naar Prevnar13).

    Maar wellicht heeft deze commentator gelijk en wordt gewoon het endpoint voor de RTS,S phase III trial niet gehaald, en wordt deze go-it-alone poging voortijdig gestaakt. We zullen het zien.
  10. [verwijderd] 8 april 2010 13:32
    quote:

    aossa schreef:

    Ook mijn idee !
    50% effectiviteit RTS/S GSK bewezen in fase2 (edoch ik herinner mij ook cijfer 45%). In fase3 misschien lagere effectiviteit leidend tot 'onvoldoende', wie weet?
    Het zal wellicht ook een wisselwerking zijn geweest tussen de minimale effectiviteitseisen van de toekomstige afnemers (Bill c.s.) en de mogelijk slechter dan verwachte uitkomsten in fase III. En dat met de wetenschap dat de combi met het Crucell veel effectiever lijkt te zijn.

    Wellicht dat Bill heeft gedacht: liever nu meer in het voortraject investeren en straks veeeeeeel meer bang for the buck. Kortom uiteindelijk veel meer levens redden per Gates-dollar.

    Er moet ook ongetwijfeld veel irritatie zijn geweest dat door machtsspelletjes niet van meet af aan voor de meest effectieve aanpak is gekozen.
  11. forum rang 4 aossa 8 april 2010 13:44
    Uit eerdere post 6 mei 06, 12:09 (in dit draadje)

    /quote (gaat over RTS,S GSK vaccine)
    This vaccine made history last year when The Lancet published the results of a clinical trial that proved it was effective for at least 18 months in reducing clinical malaria by 35 percent and severe malaria by 49 percent, in a study that involved about 2000 Mozambican children. If all goes well, this vaccine could be licensed as early as 2011-2012, and the new GSK production plant in Belgium should be ready to begin supplying millions of doses each year to children in many of Africa's poorest countries./

    biz.yahoo.com/prnews/060424/nym179.ht...
  12. maxen 12 april 2010 17:06
    quote:

    aossa schreef:

    Hé maxen, hoe schat jij de positie van GenVec in ivm de ontwikkeling van hun malaria vaccin?
    ...
    Weet ik niet, vandaag wel data van genvec studie gepresenteerd van phase I/IIa trial, met opzettelijke blootstelling aan malaria.

    Is dus een stapje verder dan huidige phase I trial van Crucell, met alleen maar vaccinatie maar geen blootstelling.

    Crucell/GSK trial wordt ook een phase I/IIa, dus daar wellicht ook opzettelijke blootstelling aan malaria.

    finance.yahoo.com/news/Encouraging-Da...

    Encouraging Data From Malaria Study Presented

    GAITHERSBURG, Md., April 12 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq:GNVC - News) announced that encouraging clinical and preclinical malaria vaccine data were presented at the Keystone Symposium -- Malaria: New Approaches to Understanding Host-Parasite Interactions taking place April 11-16, 2010 in Copper Mountain, Colorado.

    Safety, tolerability, immunogenicity, and efficacy data from the Phase 1/2a malaria trial using GenVec technology were presented. Data indicate malaria vaccines given to malaria-naive adults were found to be safe and well-tolerated with minimal local or systemic reactions and no serious vaccine-related adverse reactions. Sterile protection, a complete absence of parasites in the blood, was seen in 4 out of 15 volunteers that had been inoculated with the vaccine and subsequently challenged with the malaria parasite.

    This clinical trial is being conducted under sponsorship from the United States Army Medical Materiel Development Activity (USAMMDA) and with financial support from the U.S. Agency for International Development, the Congressionally Directed Peer Review Medical Program, and the Military Infectious Diseases Research Program.

    "The results of this study are encouraging and we are looking forward to gaining more insight regarding the potential for this vaccine," stated Dr. Douglas Brough, GenVec's Vice President of Research.
    ....
  13. forum rang 4 harvester 12 april 2010 23:25
    Morgen hopelijk ook van Crucell en partners meer duidelijkheid over malaria vaccin ontwikkeling:

    Malaria: New Approaches to Understanding Host-Parasite Interactions (F1)
    Part of the Keystone Symposia Global Health Series, Supported by the Bill & Melinda Gates Foundation. Sponsored by GlaxoSmithKline.
    Organizers: Patrick E. Duffy and Jean Langhorne
    April 11 - 16, 2010 • Copper Mountain Resort • Copper Mountain, Colorado

    www.keystonesymposia.org/meetings/Vie...

    13 april :
    Urszula Krzych, Walter Reed Army Institute of Research, USA
    Memory CD8+ T Cells in Experimental Models of Protective Immunity Induced by Attenuated Plasmodia Sporozoites

    5:00 - 7:00 PM Parasite Invasion and Arrest
    Big Horn B
    * Robert Sauerwein, Radboud University, The Netherlands

    Maria M. Mota, Instituto de Medicina Molecular, Portugal
    Blood Stage /Plasmodium/ Parasites Suppress Co-Infection in the Liver
    Urszula Krzych, Walter Reed Army Institute of Research, USA
    Memory CD8+ T Cells in Experimental Models of Protective Immunity Induced by Attenuated Plasmodia Sporozoites
    Richard J. Pleass, University of Nottingham, UK
    Engineering Antibodies for Novel Malaria Vaccines
    Audrey Gego, INSERM UMR S 945, France
    Short Talk: Identification of New Hepatocyte Factors Involved in Malaria Liver Stage Infection by Large Scale RNAi Screening

  14. flosz 23 april 2010 08:13
    Vaccine development: Hopeful results lead to first large-scale trial
    By Clive Cookson
    Published: April 22 2010 16:30
    Over the past year, 9,000 babies and young children in seven African countries have received a shot of the first malaria vaccine to undergo a large-scale clinical trial. Eventually as many as 16,000 children will receive the so-called RTS,S vaccine.
    “We are very happy with the way enrolment is going,” says Joe Cohen of GlaxoSmithKline Biologicals in Belgium, who has been working on RTS,S for more than 20 years.
    The vaccine originated with research at the Walter Reed Army Institute of Research in the US in the mid 1980s. After GSK had taken up RTS,S, tests in adult volunteers started in the US in 1992 and Africa in 1998.
    A public-private partnership between GSK and the Path Malaria Vaccine Initiative (MVI) began in 2001 to put RTS,S through more extensive “Phase 2” trials with African children. Their encouraging results – showing an efficacy for the vaccine of about 50 per cent – led to the current much larger-scale “Phase 3” trial.
    Altogether, GSK has already invested $300m in RTS,S and expects to invest at least $100m more before the project is finished. MVI has spent $200m, provided mainly by the Bill & Melinda Gates Foundation.
    The long and expensive history of RTS,S illustrates the patience needed to develop malaria vaccines. And the story is far from at an end because, while a vaccine that provides 50 per cent protection would reduce significantly the toll of 800,000 African children under five who die every year from malaria, MVI aims to have a vaccine with 80 per cent efficacy available by 2025.
    However Christian Loucq, MVI director, says future vaccines can be developed more quickly and at somewhat lower cost than RTS,S. Phase 3 vaccine trials require thousands of participants but the number becomes smaller as the vaccine becomes more effective, as greater effectiveness shows up more quickly. And the African infrastructure set up for the RTS,S trial could be used again.
    Dozens of potentially more effective candidate vaccines are in earlier stages of development in academic and industry labs around the world. For maximum effectiveness they are likely to be used in combination rather than individually.
    A partnership announced earlier this month between GSK and Crucell, the Dutch biotechnology company, is a pointer to the way things will go.
    The two companies will carry out clinical trials with a combination of RTS,S with Crucell’s Ad35-CS vaccine candidate. Animal tests have already shown a significant enhancement when the two are used together.
    The immune-stimulating antigen in both vaccines is a surface protein from the so-called sporozoite stage of the malaria parasite’s complex life cycle – the stage at which it enters the human bloodstream after a mosquito bite, and heads toward the liver where it will mature and multiply. But the antigen is packaged in different ways.
    In RTS,S the antigen protein is administered with an “adjuvant” that boosts the immune response. In Ad35-CS the antigen is inserted into an adenovirus, a type of virus associated with mild respiratory infections, which delivers it to the immune system (adenoviruses are also used as vectors for gene therapy).
    At an earlier stage of research – and using a very different antigen – is a “transmission-blocking vaccine” or TBV being developed by Johns Hopkins Bloomberg School of Public Health and the Sabin Vaccine Institute with support from MVI. This approach aims to stop the malaria parasite developing in the mosquito, so it cannot pass the infection on to humans.
    The TBV uses a mosquito antigen called AnANP1, which plays an important role in the parasite’s establishment within the insect. Field research shows that AnANP1 induces mosquito antibodies that prevent the parasite invading the insect’s gut, and the idea is that vaccinated humans would pass enhanced levels of the antigen on to the mosquitoes that bite them.
    While a TBV would offer no immediate protection against malaria to the vaccinated individual, the benefits would accumulate over time as the number of infections declines with time in the community.
    Another potentially fruitful field of research focuses on preventing malaria in pregnancy. Women are particularly vulnerable to infection while pregnant, because their immune defences are lowered and because the parasites accumulate in the placenta. Maternal malaria kills 10,000 women and 100,000 to 200,000 babies every year.
    Researchers at the University of Copenhagen are developing a potential vaccine based on the VAR2CSA antigen which should elicit antibodies that stop the parasite binding to the placenta.
    The Danish scientists have the elegant idea of attaching VAR2CSA to the human papilloma virus (HPV) vaccines that have recently been introduced to prevent cervical cancer. If HPV can indeed act as a carrier for the placental malaria vaccine, then it would be possible to protect girls in Africa against both placental malaria and cervical cancer with a single shot.
    www.ft.com/cms/s/0/4a55e110-4cf0-11df...
  15. flosz 25 april 2010 18:00
    …..a first-generation malaria vaccine by 2015.
    Even as we look forward to meeting—or even beating—that target, MVI has already crafted a strategy that is designed to build on this progress and deliver a next-generation vaccine by 2025.

    World Malaria Day 2010
    Counting malaria out
    A perspective from MVI Director, Dr. Christian Loucq
    April 25, 2010 – On this World Malaria Day, we stand at the threshold of unprecedented progress in the fight against malaria, thanks to the continuing efforts and impact of robust public-private collaborations like ours. These collaborations have produced major advances in malaria vaccine development. They have also helped to usher in a decade that promises to realize the global goal of licensing a first-generation malaria vaccine by 2015.
    Even as we look forward to meeting—or even beating—that target, MVI has already crafted a strategy that is designed to build on this progress and deliver a next-generation vaccine by 2025. MVI's success will rely, however, on our ability to continue to forge strategic collaborations and on the donor community's ability to fulfill the need for major new investments in malaria research and development (R&D).
    This decade is therefore a critical one for the malaria vaccine field. In this regard, we welcome the recent pledge by the Bill & Melinda Gates Foundation to turn it into "the decade of vaccines" and to commit $10 billion toward life-saving products for developing countries. We also strongly echo the Foundation's challenge to other donors to follow suit.
    The impact of such investments is clear. In May 2009, MVI, GlaxoSmithKline (GSK) Biologicals, together with African research centers and scientists, launched a pivotal, seven-country, efficacy trial of RTS,S—the world's most clinically advanced malaria vaccine candidate—that is expected to involve up to 16,000 African children.
    Earlier Phase 2 studies were more than encouraging. They showed that over an eight-month follow-up period, RTS,S reduced the risk of clinical episodes of malaria by 53 percent and had a promising safety and tolerability profile when used with standard infant vaccines. Today, the GSK vaccine candidate, which targets the most deadly form of the malaria parasite (Plasmodium falciparum), stands as the first to have reached a large-scale Phase 3 trial. It also promises to be the first vaccine approved for humans against any parasite.
    MVI's newly refined R&D strategy is designed to take the field even farther. Key elements of this forward-looking plan include supporting the development of other kinds of vaccine candidates, such as those that block the transmission of malaria from mosquitoes to humans and those that target the less deadly but more widespread malaria parasite, P. vivax.
    More than anything, World Malaria Day allows us to reflect on how far we've come and to focus on the malaria community's concerted effort to control and gradually eliminate a disease that still kills close to one million people each year, almost all of them young children in Africa. A malaria vaccine will be a vital part of that effort.
    Our strategic, multi-pronged approach to developing vaccines should help us to achieve the 2025 goal set by the malaria community to develop a product that is at least 80 percent effective against clinical malaria for at least four years. While we realize that more must be done if we hope to achieve the long-term goal of malaria eradication, the progress made in just the past decade gives us the hope and the confidence that it will indeed be possible one day to "count malaria out."
    www.malariavaccine.org/WMDStatement2010
  16. [verwijderd] 11 mei 2010 07:48


    Crucell and NIH Announce Start of Malaria Vaccine Trial in Burkina Faso

    Leiden, the Netherlands (May 11, 2010) - Dutch biopharmaceutical company Crucell N.V. (NYSE Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) today announced the start of a Phase I clinical study in Burkina Faso of its AdVac®-based malaria vaccine vector. Crucell is developing its malaria vaccine vector in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), the Centre National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, and the Noguchi Memorial Institute for Medical Research at the University of Ghana.



    The study is a randomized, controlled, double-blinded, dosage-escalation clinical trial evaluating the immunogenicity and safety of the recombinant malaria vaccine vector Ad35-CS in malaria semi-immune, healthy adult volunteers living in Burkina Faso. This is the first study evaluating the safety and immunogenicity of this AdVac®-based malaria vaccine vector candidate in a population residing in a malaria endemic area.



    "We are very pleased that the collaboration with NIH enables us to enter into this new trial," said Dr. Jerald Sadoff, Crucell's Chief Medical Officer at Crucell. "Using Crucell's technologies, we are on a joint mission to develop a vaccine against malaria, one of the top three killers in the world, causing close to a million deaths every year, mostly amongst children."



    The study is funded by NIAID/NIH and conducted by Burkinabè researchers at the CNRFP, lead by the director of the CNRFP Dr. Sodiomon B. Sirima, MD, PhD. "The innovative approach in designing this malaria vaccine vector gives us confidence that it could open a new, promising era in the quest for an effective malaria vaccine, which would save the lives of millions of our children." said Dr. Sirima.


    DRW
    A Phase I clinical study recently completed in the United States demonstrated that the Ad35-CS vector has an acceptable safety and immunogenicity profile in malaria naïve, healthy adult volunteers.



  17. flosz 21 september 2010 19:47
    Gesthuizen: 'Borg het publiek belang bij Crucell'

    20-09-2010 • Johnson & Johnson heeft bekend gemaakt het Leidse bedrijf Crucell over te willen nemen. Dit bedrijf doet onderzoek naar medicijnen en vaccins, onder andere voor griep en hepatitis. Het is een spin-off van de Universiteiten van Leiden en Utrecht. SP-Tweede Kamerlid Gesthuizen: 'ER ZITTEN MILJOENEN OVERHEIDSINVESTERINGEN IN DIT BEDRIJF. JOHNSON&JOHNSON IS EEN AMERIKAANS BEDRIJF. WE MOETEN VOORKOMEN DAT DOOR DEZE OVERNAME STRAKS BLIJKT DAT WE MET ONS BELASTINGGELD NIET NEDERLAND, MAAR DE VERENIGDE STATEN HEBBEN GESTEUND.'
    Volgens Gesthuizen is er niks op tegen dat buitenlandse bedrijven in Nederland investeren. Er moet in dit geval echter wel goed gekeken worden of het publieke belang goed geborgd is. In Crucell zit miljoenen overheidsgeld, in de vorm van onderzoekssubsidies. Verder zit in het bedrijf ook veel publiek gefinancierd kapitaal in de vorm van kennis die is verworven op de universiteiten.
    De bestuursvoorzitter van Crucell, de heer Brus, vangt 11,9 miljoen als het bedrijf wordt overgenomen. Gesthuizen: 'Aan dit soort beloningen, waarbij bestuurders er een groot persoonlijk belang bij hebben dat het bedrijf wordt overgenomen, moeten we paal en perk stellen. Dit vertroebelt de besluitvorming. Het persoonlijke belang dreigt zwaarder te wegen dan het bedrijfsbelang. Dat kan niet de bedoeling zijn.'
    www.sp.nl/economie/nieuwsberichten/79...
  19. flosz 27 september 2010 22:18

    THE SECOND INTERNATIONAL CONFERENCE
    MALARIA VACCINES FOR THE WORLD MVW 2010 28-30 SEPTEMBER 2010, KELLOGG CONFERENCE HOTEL
    GALLAUDET UNIVERSITY, WASHINGTON DC, USA

    SESSION 9: VACCINE DEVELOPMENT
    Moderator: Joe Cohen (GSK Biologicals, Rixensart, Belgium)

    ‘Title to be confirmed’
    Jaap Goudsmit (Crucell, Leiden, The Netherlands)

    SESSION 5: Special Session: ‘African Researchers Tackle an African Affliction: Recent Milestones and the Way Forward for the RTS,S Malaria Vaccine Candidate’

    SESSION 11 : VACCINE & ADJUVANT DEVELOPMENT
    Moderator: Jean Langhorne (NIMR, Mill Hill, London, UK)
    ‘Virosome-formulated peptidomimetics as malaria vaccines’
    Blaise Genton, Claudia Dauenberger, Marcel Tanner,
    Nicole Westerfeld, sabine Stoffel, Rinaldo Zurbriggen,
    Salim Abdulla and Gerd Pluschke
    (Policlinique Medicale Universitaire, Lausanne, Switzerland)

    www.meetingsmanagement.com/pdf/MVW_20...
  20. flosz 29 september 2010 10:05
    International Malaria Vaccines For The World Conference To Showcase Scientific Push For "next Generation" Products
    Malaria experts from around the world are gathering in Washington this week to discuss cutting edge research into a new generation of malaria vaccines that includes efforts to construct a genetically engineered "DNA vaccine," to uncover new vaccine targets that appear early in malaria infections, and to develop immunizations that could block malaria transmission between mosquitoes and humans.

    The reports from the frontlines of malaria vaccine research will be delivered at the Second International Malaria Vaccines for the World Conference, to be held September 28-30 in Washington, DC, which will feature an extensive discussion of the portfolio of projects supported by the PATH Malaria Vaccine Initiative (MVI). MVI is committed to developing vaccines that can help eradicate a disease that kills nearly 900,000 people each year, most of them children in sub-Saharan Africa.

    "We are eager to build on the progress we have made in the last 10 years and are challenging the malaria vaccine community and others to produce innovations that will enable us to eliminate this disease once and for all," said Dr. Christian Loucq, director of MVI.

    MVI is currently partnering with GlaxoSmithKline (GSK) Biologicals and research centers across Africa to conduct Phase 3 testing of GSK's RTS,S malaria vaccine, the world's most clinically advanced malaria vaccine candidate. If successful in Phase 3 testing and licensure, RTS,S could satisfy the intermediate goal set forth in the international community's Malaria Vaccine Technology Roadmap of a "first-generation" malaria vaccine that is at least 50 percent effective against severe disease and death and lasts more than one year.

    Diversity of new approaches

    Much of the research to be presented at the MVI portfolio session at the World Conference is focused on identifying and developing new malaria vaccine targets and approaches. MVI is already laying the foundation for a next-generation vaccine that is at least 80 percent effective against clinical disease and lasts longer than four years. Even more ambitiously, MVI is supporting the development of vaccine approaches that fight malaria by interrupting its transmission from mosquitoes to humans.

    Blocking transmission of malaria to others

    Rhoel Dinglasan of the Johns Hopkins Bloomberg School of Public Health (JHSPH) will offer an update, including preclinical results, on the partnership involving JHSPH, MVI, and the Sabin Vaccine Institute to develop a transmission-blocking vaccine. The project is focused on an antigen found in malarial mosquitoes called AnAPN1, which appears to play a major role in malaria parasite establishment within the mosquito.

    Preliminary field research has shown that antibodies induced by this antigen are capable of blocking transmission of the two deadliest malaria parasites, Plasmodium falciparum and P. vivax. When a mosquito takes blood from a person vaccinated with these antibodies, disease transmission would be interrupted by preventing the parasite from attaching to and invading the mosquito's gut. Interrupting this critical step in the life cycle of the parasite would serve to reduce the number of infected mosquitoes in endemic areas, thereby reducing subsequent rates of transmission to humans. Such a vaccine approach is viewed as being a critical tool to support efforts to eliminate malaria in the future.
    Expanding the malaria vaccine antigen library

    Patrick Duffy, an investigator with the National Institute of Allergy and Infectious Diseases (NIAID) who also heads the malaria program at Seattle BioMed, will provide an update on new efforts to identify promising targets for a malaria vaccine, focusing on the pre-erythrocytic stage, before the parasite reaches the bloodstream.

    "We are moving quickly to provide vaccine developers with specific antigens that could improve the effectiveness of immunizations by forcefully engaging the disease soon after the parasite enters into the body," Duffy said.

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