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Draadje HIV/AIDS

252 Posts
Pagina: «« 1 ... 8 9 10 11 12 13 »» | Laatste | Omlaag ↓
  1. forum rang 4 aossa 25 september 2009 15:18
    GenVec Receives Fourth-Year Funding From NIAID For HIV Vaccine Contract

    GAITHERSBURG, Md., Sept. 24 /PRNewswire-FirstCall/ -- GenVec, Inc. (Nasdaq: GNVC - News) announced today that the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health (NIH), has executed its third option period (year four) under a previously announced, five-year contract with GenVec valued at up to $52 million for the production of HIV vaccines. GenVec will receive up to $2.3 million for the fourth year, which will support the generation of HIV vaccine candidates with GenVec's alternate adenovirus serotype technology.
  2. flosz 26 september 2009 14:25
    The Scripps Research Institute and IAVI Host Symposium to Launch Research Center Dedicated to Solving the Neutralizing Antibody Problem
    Published: September 24, 2009

    IAVI and The Scripps Research Institute launch a new research center, the IAVI Neutralizing Antibody Center at The Scripps Research Institute. Scientists at the Center will focus on designing AIDS vaccines that elicit antibodies that work against a number of HIV types to protect from infection with the virus.
    www.iavi.org/news-center/Pages/PressR...

    IAVI Statement on Results of Phase III ALVAC-AIDSVAX Trial in Thailand
    Published: September 24, 2009
    www.iavi.org/news-center/Pages/PressR...

    RV144 Fact Sheet:
    www.hivresearch.org/phase3/MHRP-Phase...
  3. flosz 26 september 2009 15:21
    A two-shot combo reduces the risk of HIV infection.
    The largest HIV vaccine trial to date has shown moderate success at preventing infection by the virus.

    The experimental vaccine — a combination of two older shots that failed to work on their own — reduced the risk of someone contracting HIV by nearly a third. Scientists, however, are still scratching their heads as to how the double-shot approach blocks the virus.

    "I don't think anybody knows why this worked the way it did," says Dan Barouch, an immunologist at the Beth Israel Deaconess Medical Center in Boston, Massachusetts. "It's the largest step forward that's ever occurred in the HIV-vaccine field, but there's a tremendous amount of more work that will need to be done."

    Many HIV vaccine experts had previously criticized the approach as a waste of time because each of the vaccine components had a poor track record1. The primer, called ALVAC, conferred little to no immune protection in multiple early-phase clinical trials, and the booster, called AIDSVAX, had flopped twice in high-profile, large-scale trials. "I thought it was sort of a crazy trial," says David Markovitz, who studies HIV at the University of Michigan, Ann Arbor. "It was based on poor data and it didn't seem to make a lot of sense at the time."

    Boasso points out that the vaccine still has a long way to go before it gets rolled out on a larger scale. "Nobody would be considering licensing a vaccine that is 30% effective," he says. "You'd want to be aiming for 70–80% at least." Researchers should now work to optimize the vaccine or the dose schedules to improve the odds of protection, he says.
    www.nature.com/news/2009/090924/full/...
  6. [verwijderd] 9 oktober 2009 13:24
    CytoDyn Transfers Research on Novel AIDS Drug to Massachusetts General Hospital
    Last update: 10/8/2009 9:00:03 AMS

    ANTA FE, N.M., Oct 08, 2009 (BUSINESS WIRE) -- In response to new economic and regulatory realities, CytoDyn, Inc. (Pink Sheets:CYDY) has made a sea change in its strategy for developing Cytolin(R), the Company's unique immune therapy for treating HIV/AIDS. Studies of the drug will be designed and conducted by Massachusetts General Hospital, one of the premier teaching hospitals in Boston, Massachusetts, as part of its mission to advance medical knowledge and treatments through research, education and patient care.

    The Current Standard for Treating HIV/AIDS During the past decade, significant improvements in the antiviral "cocktails" used to treat HIV/AIDS have transformed this once fatal disease into a chronic, manageable condition. Many such antiviral drugs are available, including Atripla(R), which combines drugs from Bristol-Myers Squibb (BMY) and Gilead Sciences (NasdaqGS:GILD); Viracept(R) from Pfizer (PFE); and Norvir(R) from Abbott Laboratories (ABT), to name but a few.

    These drugs are the ingredients of Highly Active Antiretroviral Therapy (HAART), which has saved countless lives and is well tolerated by most patients, although all drugs have side effects. The current standard of treatment recommends withholding antiviral drugs until the disease has progressed to the point where the drugs are required to maintain a patient's health, typically a period of about five years from initial infection.

    A chief reason for withholding treatment during the early years of HIV infection is that antiviral drugs attack the virus directly. As a result, natural selection promotes the evolution of HIV into species that are resistant to those drugs. If antiviral drugs were prescribed too early, then the virus might become resistant to those drugs, rendering them ineffective, by the time they were necessary to maintain a patient's health.

    About Cytolin(R) Cytolin(R) is a monoclonal antibody administered by intravenous infusion and might expand the standard of treatment. In preliminary clinical trials, and in compassionate use involving hundreds of patients treated for about two years, Cytolin(R) produced encouraging results in delaying or reversing disease progression while acquiring a good safety record. Significantly, Cytolin(R) is not an antiviral drug although it has a significant, albeit indirect, antiviral effect (log reduction in viral burden).

    A first-in-class drug, Cytolin(R) is designed to prevent the wholesale destruction of helpful CD4 T cells by a person's own killer T cells. The killer T cells are made by the human body in response to HIV infection as part of the natural defense against the virus. As first shown by Zarling, et al in 1990 (Journal of Immunology, vol. 144, page 2992), the ability of these killer T cells to indiscriminately destroy CD4 T cells is a trait unique to humans, explaining why HIV infection does not cause disease in the other species the virus can infect.

    It has been known since the beginning of the AIDS pandemic that a wholesale loss of CD4 T cells is the reason why individuals infected with HIV become susceptible to the opportunistic infections and cancers that characterize AIDS.

    Up until the 1990s when three independent studies identified the killer T cells as the cause of the problem, the reason for the wholesale loss of CD4 cells remained a mystery because the virus infects relatively few CD4 T cells. The fact that Cytolin(R) has no direct effect on the life-cycle of the virus precludes the emergence of Cytolin(R)-resistant virus due to the long-term use of Cytolin(R). This is in contrast to the antiviral drugs whose use promotes the evolution of drug-resistant virus. Consequently, a potential indication for Cytolin(R) would be to administer it early in the infection in order to delay the natural progression of the disease and, therefore, the time when antiviral drugs become necessary. If so, healthcare providers could treat individuals infected with HIV more quickly, rather than spending years just watching and waiting.

    Cytolin(R) is the brainchild of scientist Allen D. Allen, the CEO of CytoDyn, which has been developing Cytolin(R) as its lead product since the Company's inception in 2003. Notwithstanding CytoDyn's previous public discussions and efforts centered on other potential indications, the Company is now committed to developing Cytolin(R) for the above indication; that is, as a monotherapy for treating early HIV infection before the antiviral drugs are indicated. The Company believes this best serves the needs of those infected with HIV and the physicians who treat them. About The Study CytoDyn has agreed to provide a research grant and cGMP product to Massachusetts General Hospital for the purpose of conducting an ex-vivo study of Cytolin(R).

    The study will enroll 10 adults with early HIV infection and 10 healthy controls, each of whom will be required to participate for six months. This study is intended as a prelude to an in vivo study and will take advantage of the facilities available at Massachusetts General Hospital to confirm, and perhaps sharpen, the role of killer T cells in causing the wholesale loss of CD4 T cells, as well as the mechanisms of action responsible for the clinical benefits observed in patients treated with Cytolin(R), including the roles played by various cytokines and cluster determinants (the "CD" used to categorize lymphocytes, such as "CD4 T cells").

    The Company is pleased to report that the Principal Investigator is Eric S. Rosenberg, MD, an Associate Professor of Medicine in the Infectious Diseases Division of Massachusetts General Hospital and a prominent researcher specializing in HIV/AIDS. More than the Principal Investigator, Dr. Rosenberg designed the protocol for the study after an extensive review of the relevant literature and human experience related to Cytolin(R).

    His review was aided by a comprehensive due diligence report kindly prepared by David Scondras, a Boston-based AIDS activist. Risks of Academic Research Massachusetts General Hospital is a nonprofit, tax-exempt facility with the mission of improving the public health by engaging in research for the purpose of discovering and making available to the public new and improved medical treatments and information.

    As a consequence, Massachusetts General Hospital does not conduct studies unless its researchers are free to publish the study results as, how, and when they see fit, provided only that the trade secrets of CytoDyn may not be disclosed. When researchers have such unrestricted freedom to publish, it can pose a risk to the company developing a drug.

    This is because the outcome of clinical research is uncertain and the results may differ significantly from the expectations of the company and the researchers. However, CytoDyn's management believes this risk is minimal inasmuch as Cytolin(R) has already been used to treat hundreds of patients over extended periods of time. Consequently, the study is unlikely to produce unexpected or surprising results that would call the safety and efficacy of Cytolin(R) into question. Nonetheless, the study may fail to meet its objectives for any number of reasons. These include but are not limited to the failure of in vivo events to manifest in vitro, enrollment of patients whose HIV infection is still too early,
  7. maxen 10 oktober 2009 11:30
    Wall Street Journal,
    OCTOBER 10, 2009

    Data Call Into Question HIV Study Results

    By GAUTAM NAIK and MARK SCHOOFS

    Researchers from the U.S. Army and Thailand announced last month they had found the first vaccine that provided some protection against HIV. But a second analysis of the $105 million study, not disclosed publicly, suggests the results may have been a fluke, according to AIDS scientists who have seen it.

    The second analysis, which is considered a vital component of any vaccine study, shows the results weren't statistically significant, these scientists said. In other words, it indicates that the results could have been due to chance and that the vaccine may not be effective.

    The additional data were available to the researchers on Sept. 24 when they announced the trial results, but they chose not to disclose them, said Jerome Kim, a scientist with the U.S. Army who was involved in the study. News of the second analysis was first reported on the Web site of Science magazine, but the story didn't provide specific data. Full details of the trial are to be aired at an AIDS meeting in Paris that starts Oct. 19.

    The incomplete disclosure raises the question of whether the Army, the Thai government and the U.S. National Institutes of Health -- which helped fund the study -- rushed to give a positive spin to what may turn out to be another inconclusive AIDS-vaccine effort.

    "We thought very hard about how to provide the clearest, most honest message," Dr. Kim said. "We stand by the fact that this is a vaccine with a modest protective effect." He called the trial results "complex."

    Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the part of the NIH that oversees AIDS research, declined to comment.
    ...

    verder lezen:
    online.wsj.com/article/SB125511780864...
  8. flosz 11 oktober 2009 19:17
    quote:

    flosz schreef:

    Sanofi Pasteur Commends Results
    of First HIV Vaccine Study to Show
    Some Effectiveness in Preventing HIV

    …..safe and modestly effective in preventing HIV infection.
    en.sanofi-aventis.com/binaries/200909...

    Art. Cohen(5 oktober) erbij.

    Unrevealed Analysis Weakens Claim of AIDS Vaccine "Success"
    by Jon Cohen
    When the U.S. Army and its collaborators in Thailand announced at press conferences on 24 September that a large clinical trial of an AIDS vaccine had lowered the rate of new HIV infections by about one-third, researchers were surprised and encouraged. Although it was only a modest reduction, it was the first positive result from any AIDS vaccine trial.
    Now some researchers who have seen more of the data in confidential briefings are complaining that a fuller analysis undermines even cautious claims of success, and they are raising questions about the way the results were announced.
    The press conference and press releases discussed an analysis that included all 16,000 people who participated in the trial, except for seven who were infected before receiving any doses of the two vaccines that were used in combination. Seventy-four people in the placebo arm of the study became infected with HIV, while the similarly sized vaccinated group only had 51 infections—a 31.2% efficacy. The analysis indicated that there was about a 96% level of confidence that the effect was real and not due to chance—just above the 95% cutoff that is widely used as a measure of statistical significance.
    In the private briefings, researchers learned that a second analysis, which is usually performed in vaccine studies and was part of the Thai study’s design, also found that vaccine recipients had fewer infections, but the reduction was not statistically significant and the level of efficacy was slightly lower. This analysis eliminated people in both groups who did not rigorously follow the protocols. “Anything that really works, you’ll have enough robustness in results to be significant with both analyses,” says Douglas Richman, an AIDS researcher at the University of California, San Diego, a longtime critic of the study. Richman did not discuss the specific results with Science.
    “The press conference was not a scholarly, rigorously honest presentation,” said one leading HIV/AIDS investigator, who like others asked that his name not be used. “It doesn’t meet the standards that have been set for other trials, and it doesn’t fully present the borderline results. It’s wrong.” Two biostatisticians who specialize in HIV prevention trials and have not seen the data, said that the results from all participants are the more important data, but they were puzzled that the press conference did not include the analysis that excluded those who didn’t follow the protocols. “I think if people saw [the two analyses] diverging in a vaccine study, they’d have a lot of questions,” says David Glidden, a biostatician at the University of California, San Francisco.
    Colonels Nelson Michael and Jerome Kim, researchers with the U.S. Army who helped run the study, strongly objected to the assertion that they gave the data a positive spin. “We needed to get enough information out so we could give the world community a fair glimpse of what we’ve learned,” said Michael. He notes that in addition to showing select researchers a fuller presentation of the data, a paper under review at the New England Journal of Medicine describes both analyses, and all the findings will be discussed on 20 October at an open AIDS vaccine meeting in Paris. “We tried very carefully to make sure that message was crystal clear,” said Michael. “There’s now hope. But that said, we’ve tried to be very careful not to oversell this.”
    Several researchers wonder why the data were even released publicly before the Paris meeting. People running the trial learned the results on 10 September, and Michael said there was concern that the information would leak before 20 October. Thai collaborators asked for the 24 September date, Mahidol Day, which commemorates the passing of the current king’s father, a clinician who studied public health at Harvard University.
    The debate over the way the results were presented will have no immediate practical impact because even under the most optimistic assessment, the vaccine offered too little protection to be a serious candidate for widespread use. But a modest success, even one that is marginally significant, may point the way to new vaccine strategies. “I think that the field is energized,” said Kim. “Everyone should wait until the data are out.”
    Several critics point out that a press conference 2 years ago about another AIDS vaccine efficacy trial—which was prematurely stopped because the product clearly was not working—researchers reported both analyses (subs. req). What is more, the AIDS Vaccine Advocacy Coalition, a nonprofit that issued a report about interpreting the Thai results before the data were unveiled at the press conference, stressed the importance of both. “The safest route is to report both ... and to analyze any difference,” the report states. “Advocates’ take-home message: no matter what the headlines say, a single number is not the full result.”
    blogs.sciencemag.org/scienceinsider/2...
  9. flosz 11 oktober 2009 19:20
    NIH Launches 2009 H1N1 Influenza Vaccine Trials In HIV-infected Pregnant Women

    ScienceDaily (Oct. 11, 2009) — The first clinical trials to test whether the 2009 H1N1 influenza vaccine can safely elicit a protective immune response in pregnant women has just been launched, and a trial to conduct the same test in HIV-infected children and youth will begin mid-October.
    The International Maternal Pediatric Adolescent AIDS Clinical Trials Group is conducting the studies, which are sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), both part of the National Institutes of Health.

    Meer via:
    www.sciencedaily.com/releases/2009/10...
    (Novartis).
  10. flosz 20 oktober 2009 14:36
    di 20 okt 2009, 13:31
    'Aidsvaccin minder effectief dan geclaimd'
    PARIJS - Een recent onderzoek waarin wetenschappers claimen dat zij een aidsvaccin hebben ontdekt, wordt door andere onderzoekers als een stuk minder succesvol bestempeld. Volgens de critici zijn de uitkomsten niet goed genoeg om zulke conclusies te trekken, meldde de BBC dinsdag vanaf een conferentie in Parijs.
    De wetenschappers hebben het vaccin in Thailand getest op meer dan 16.000 mensen. Daaruit bleek volgens hen dat het risico op hiv, het virus dat aids kan veroorzaken, door het vaccin daalde met 31 procent.
    Nu het complete onderzoek is vrijgegeven, en niet alleen de resultaten, blijkt dat 51 mensen uit de groep die het vaccin kreeg, toch hiv opliepen. In de groep die een placebo kreeg toegediend, kregen 74 mensen het virus. Dat verschil is volgens de critici te klein om te spreken van een doorbraak.
    Vooral als de mensen die in de eerste zes maanden van het onderzoek hiv kregen niet meegeteld worden, is het verschil tussen de onderzoeksgroep en de controlegroep te klein. Deze mensen zouden al ziek zijn geworden voordat het vaccin zijn werk had kunnen doen. Het duurt na besmetting zes maanden voordat het hiv-virus in het bloed zichtbaar is.
    Het Amerikaanse leger, dat het onderzoek samen met het Thaise ministerie van Gezondheidszorg uitvoerde, heeft inmiddels bevestigd dat de verschillen te klein zijn als mensen die in de eerste zes maanden hiv kregen, niet worden meegeteld.
    Het Nederlandse AIDS fonds had eerder al verwonderd gereageerd op de uitkomst van het onderzoek. „Dat hadden we niet verwacht omdat een eerder getest ander middel dat is gebaseerd op dezelfde theorie, niet effectief bleek”, aldus een woordvoerster toen. Toch vlamde de hoop op dat het middel wel werkzaam zou zijn.
    Wereldwijd leven ruim 33 miljoen mensen met hiv of aids. Inmiddels hebben 3 miljoen mensen in ontwikkelingslanden toegang tot aidsremmers. Nog eens 7 miljoen hebben deze medicijnen nodig, maar krijgen ze niet. Aidsremmers werken anders dan een vaccin. Door de remmers leiden mensen met hiv langer een gezond leven. Een vaccin zou ervoor moeten zorgen dat mensen het virus helemaal niet oplopen.
    www.telegraaf.nl/buitenland/5119205/_...

    *****************

    Have Faith in an AIDS Vaccine
    18 Oct 2009
    www.iavi.org/news-center/Pages/PressR...

  12. forum rang 4 aossa 21 oktober 2009 13:03
    Crucell HIV Vaccine: Promising Preliminary Results Phase I Study Presented by Dr Dan Barouch at AIDS Vaccine 2009 in Paris

    Leiden, The Netherlands (October 21, 2009) - Dutch biopharma company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) today announced that preliminary results of the Phase I study of its HIV vaccine were presented at La Conférence AIDS Vaccine 2009 in Paris, France. The presentation was given by Dr Dan H. Barouch, MD, PhD, Associate Professor of Medicine, Division of Vaccine Research, Department of Medicine at the Beth Israel Deaconess Medical Center (BIDMC) in Boston, USA. The preliminary results of the Phase I study show that this HIV candidate vaccine is safe and immunogenic.

    In April 2008, Crucell announced the start of a Phase I clinical study of the novel recombinant HIV vaccine. The vaccine is based on its AdVac® and PER.C6® technologies, using adenovirus serotype 26 (rAd26) as vector and is jointly developed by Crucell and the BIDMC, funded by a grant from the US National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The rAd26 vector is specifically designed to avoid the pre-existing immunity to the more commonly used adenovirus serotype 5 (Ad5). The Phase I clinical study is being conducted at the Brigham and Women's Hospital in Boston, USA and involves 48 healthy volunteers. Boost vaccinations are ongoing.

    "The vaccine is designed to overcome the pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5. These encouraging preliminary results are paving the way for the further development of this vaccine vector for HIV and other pathogens." says Dr Barouch.

    About AdVac® technology
    AdVac® technology is a vaccine technology developed by Crucell and is considered to play an important role in the fight against emerging and re-emerging infectious diseases, and in biodefense. The technology supports the practice of inserting genetic material from the disease-causing virus or parasite into a 'vehicle' called a vector, which then delivers the immunogenic material directly to the immune system. Most vectors are based on an adenovirus, such as the virus that causes the common cold. The AdVac® technology is specifically designed to manage the problem of pre-existing immunity in humans against the most commonly used recombinant vaccine vector, adenovirus serotype 5 (Ad5), without compromising large-scale production capabilities or the immunogenic properties of Ad5. AdVac® technology is based on adenoviruses that do not regularly occur in the human population, such as Ad35. In contrast to for instance Ad35 antibodies, antibodies to Ad5 are widespread among people of all ages and are known to lower the immune response to Ad5-based vaccines, thereby impairing the efficacy of these vaccines. All vaccine candidates based on AdVac® are produced using Crucell's PER.C6® production technology.

    About PER.C6® technology
    Crucell's PER.C6® technology is a cell line developed for the large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. The strengths of the PER.C6® technology lie in its safety profile, scalability and productivity under serum-free culture conditions.

    About Beth Israel Deaconess Medical Center
    BIDMC is a patient care, teaching and research affiliate of Harvard Medical School, and consistently ranks in the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is clinically affiliated with the Joslin Diabetes Center and is a research partner of Dana-Farber/Harvard Cancer Care Center. For more information, visit www.bidmc.harvard.edu.

    About Brigham and Women's Hospital
    BWH is a 747-bed non-profit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery network. BWH is committed to excellence in patient care with expertise in virtually every speciality of medicine and surgery. The BWH medical pre-eminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human disease, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 M in funding. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative. For more information about BWH, please visit www.brighamandwomen's.org.

    About Crucell
    Crucell N.V. (Euronext, NASDAQ: CRXL; Swiss Exchange: CRX) is a global biopharmaceutical company focused on research development, production and marketing of vaccines, proteins and antibodies that prevent and/or treat infectious diseases. Its vaccines are sold in public and private markets worldwide. Crucell's core portfolio includes a vaccine against hepatitis B, a fully-liquid vaccine against five important childhood diseases and a virosome-adjuvanted vaccine against influenza. Crucell also markets travel vaccines, such as the only oral anti-typhoid vaccine, an oral cholera vaccine and the only aluminum-free hepatitis A vaccine on the market. The Company has a broad development pipeline, with several product candidates based on its unique PER.C6® production technology. The Company licenses its PER.C6® technology and other technologies to the biopharmaceutical industry. Important partners and licensees include DSM Biologics, sanofi-aventis, Novartis, Wyeth, GSK, CSL and Merck & Co. Crucell is headquartered in Leiden, the Netherlands, with subsidiaries in Switzerland, Spain, Italy, Sweden, Korea and the U.S. The Company employs over 1000 people. For more information, please visit www.crucell.com.

    Forward-looking statements
    This press release contains forward-looking statements that involve inherent risks and uncertainties. We have identified certain important factors that may cause actual results to differ materially from those contained in such forward-looking statements. For information relating to these factors please refer to our Form 20-F, as filed with the U.S. Securities and Exchange Commission on April 22, 2009, in the section entitled 'Risk Factors'. The Company prepares its financial statements under International Financial Reporting Standards (IFRS).


    For further information please contact:

    Crucell N.V.
    Oya Yavuz
    Vice President
    Corporate Communications & Investor Relations
    Tel. +31-(0)71-519 7064
    ir@crucell.com
    www.crucell.com

    PDF file
    investors.crucell.com/C/132631/PR/200...
  13. bilbo3 21 oktober 2009 17:30
    en hierbij een extract van de presentatie van Barouch. ik begrijp het niet maar wellicht kan iemand wat toelichting geven:

    www.hivvaccineenterprise.org/conferen...

    OA05-06 LB
    First-in-human phase 1 safety and immunogenicity of an Adenovirus Serotype 26 HIV-1 vaccine vector
    LR Baden1, R Dolin3, KL O’Brien3, P Abbink3, A La Porte3,
    MS Seaman3, E Choi1, R Tucker1, M Weijtens2, MG Pau2,
    J Goudsmit2, DH Barouch3
    1Brigham and Women’s Hospital, Boston, MA, USA; 2Crucell, Leiden, Netherlands; 3Beth Israel Deaconess Medical Center, Boston, USA
    Background: Adenovirus serotype 26 (Ad26) is a rare Ad serotype that differs substantially from Ad5 in terms of baseline seroprevalence, receptor usage, tropism, innate immune profile, adaptive immune phenotype, and protective efficacy in the SIV/macaque model. Here we report the initial safety and immunogenicity assessment of a prototype Ad26 vector in humans.
    Methods: Ad26 expressing the VRC EnvA test antigen was manufactured by Crucell. 36 Ad26 seronegative, healthy subjects were enrolled in a randomized, double-blinded, placebo-controlled, dose-escalation phase 1 study. Groups of 12 subjects received doses of 109, 1010, or 1011 vp of the Ad26-EnvA vector (N=10/group) or placebo (N=2/group) at weeks 0, 4, and 24. We performed a pre-specified blinded immunogenicity analysis after the first two immunizations. Validated IFN-gamma ELISPOT assays were performed with positivity criteria of >55 SFC/106 PBMC and >4-fold background.
    Results: 26/36 subjects were female, and 70/72 vaccinations were administered. Some reactogenicity was observed after the initial immunization in the highest dose group but typically resolved within 24 h. No vaccine-associated AEs or SAEs occurred. In all three dose groups, 2 subjects/group exhibited no detectable vector- or insert-specific immune responses at any timepoint, whereas 10 subjects/group developed positive Ad26 NAb titers, EnvA-specific ELISA titers, and EnvA-specific ELISPOT responses following vaccination. In the 109 vp dose group, the median ELISA titer was 1000 (IQR 300-3,000) and the median ELISPOT response was 381 SFC/106 PBMC (IQR 125-545) at week 8. In the 1011 vp dose group, the median ELISA titer was 5,477 (IQR 3,000-10,000) and the median ELISPOT response was 365 SFC/106 PBMC (IQR 85-715) at week 8.
    Conclusion: The Ad26 vector is safe and immunogenic in humans at all three doses. Ad26 is therefore a promising new vector for further clinical studies to evaluate novel inserts such as mosaic HIV-1 Gag, Pol, Env antigens.
  14. flosz 22 oktober 2009 09:11
    Database of AIDS Vaccine Candidates in Clinical Trials
    Database last updated: October 13, 2009
    www.iavireport.org/trials-db/Pages/Tr...
    ******************
    @bilbo, webcast persconf. interessant luistervoer.
    (Toelichting Dan en ook de Q&A, o.a. mbt Ad26-vector).

    Ter aanvulling:

    AIDS Vaccine 2009
    October 19 - 22, 2009
    Marriott Rive Gauche Conference Center, Paris, France
    Close
    AIDS Vaccine 2009 will bring together both established and new young research scientists, with clinicians, epidemiologists and public health experts to create a dynamic and interactive environment with the aim of sharing experience and scientific adv

    Oral abstract session
    OA05-06 LB
    www.hivvaccineenterprise.org/conferen...

    S06-04
    HIV-1 mosaic antigens expand cellular immune breadth and depth in Rhesus Monkeys
    D Barouch1, and B Korber2
    1Beth Israel Deaconess Medical Center, Boston, MA, USA; 2Los Alamos National Laboratories, Los Alamos, NM, USA
    Viral diversity represents an enormous challenge for the development of an HIV-1 vaccine. In particular, natural sequence antigens have been shown to elicit only limited breadth of cellular immune responses in both nonhuman primate studies and clinical trials to date. Here we explore the potential utility of HIV-1 mosaic antigens as compared with consensus antigens and natural sequence antigens expressed by Ad26 vectors in rhesus monkeys. We demonstrate that HIV-1 mosaic antigens expand celluar immune breadth, which theoretically may improve coverage of global virus diversity. We also show that HIV-1 mosaic antigens augment cellular immune depth, which we define as the capacity to elicit responses simultaneously to multiple epitope variants, and which theoretically may inhibit viral escape or exact a higher fitness cost for escape. These data suggest that further evaluation of HIV-1 mosaic antigens in clinical trials is warranted.
    www.hivvaccineenterprise.org/conferen...

    Uit de persconferentie d.d. 21-10-2009
    Dan Barouch mbt Ad26 en problemen Ad5.
    Webcast op 14:30
    wcc.webeventservices.com/view/wl/r.ht...
  16. MeawandMoo1 27 oktober 2009 20:01
    Aanvullende financiering voor:
    MANUFACTURING OF NOVEL ADENOVIRUS PRIME-BOOST HIV-1 VACCINE

    door:
    NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES

    Bedrag: $1,338,986

    Budget Start Date: 1-SEP-2009
    Budget End Date: 31-AUG-2011

    projectreporter.nih.gov/reporter_Sear...

    Overigen blijven vernoemd:
    FY Total Cost by IC$11,476,040
    FY Total Cost by IC $34

    Positief: aanvullende financiering voor HIV-onderzoek en voldoende interessant om door te ontwikkelen.
    Negatief: fase I zal nog wel extra verlengd worden (Malaria-route)
  17. [verwijderd] 27 oktober 2009 22:36
    regarding HIV

    How much "profit" has Crucell derived from the biggest deals ever...not including research reimbursement...

    Ebola
    Flucell-Sanofi
    Medimmune
    Wyeth
    J+J

    Answer-about 20 million...and if you are going to argue the J+J deal...watch out. That deal was for Brus's retirement and to give J+J control of the company for 1/20th the value...the Street has spoken on the J+J deal...as much as they can.

    Brus lies every time he says that the other company has gagged him. Of course he can talk about the J+J deal...J+J isn't stopping him...have you ever heard of the other company in a Crucell deal say "We have asked Crucell to be quiet on the details of this deal" No, you haven't. It is Crucell that doesn't want to talk about the details of the deals. Why? Because the deals do not benefit the shareholders...period. If a deal is good you crow about it...if it sucks you say you can't talk about it...simple as that.
  18. flosz 3 november 2009 18:26
    AIDS: Panel Warns That Without New Direction, Epidemic Will Remain Out of Control at 50
    By DONALD G. McNEIL Jr.
    Published: November 2, 2009
    Unless there is a drastic change in approach, the AIDS epidemic will still be out of control on its 50th anniversary in 2031, a panel of AIDS experts predicted in an analysis being published Tuesday in the journal Health Affairs.
    www.nytimes.com/2009/11/03/health/03g...
    content.healthaffairs.org/index.dtl

    Tuesday, Nov. 3, 2009

    NIAID Director Fauci Discusses Compelling Scientific Challenges in HIV/AIDS Research
    Research Efforts toward a Cure and New Tools of Prevention are Critical
    WHAT: Approximately 2.7 million people were infected with HIV worldwide in 2007—an average of more than 7,000 individuals each day. In the United States, nearly 600,000 people have died of HIV/AIDS, and an estimated 1.1 million people currently are living with HIV infection. Each year for about the past 15 years, approximately 56,000 people in the United States have become newly infected with HIV.
    In a new article in Health Affairs, Anthony S. Fauci, M.D. and Gregory K. Folkers, M.S., M.P.H., discuss the urgent imperative both to scale up proven tools of HIV treatment and prevention, and to develop bold new interventions—from curative therapies to vaccines and other new prevention modalities. Dr. Fauci is director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health. Mr. Folkers is health scientist and chief of staff in the Immediate Office of the Director, NIAID.
    The authors note that only a fraction of people who need HIV treatment, prevention and related services is receiving them. Even if access to scientifically proven HIV services were greatly improved by increased funding or improved efficiencies, slowing and ultimately ending the HIV/AIDS pandemic also will likely require major advances in two areas. First, curing a sizable proportion of those already infected with the virus such that lifelong therapy is not required; and, second, developing more powerful prevention tools to slow the rate of new infections. The authors assert that the scientific challenges related to these two goals are the most important issues in HIV/AIDS research today.
    The authors explain that a cure theoretically could involve complete eradication of HIV from the body, a “sterilizing cure.” Alternatively, a cure could shrink the amount of HIV in a person’s body to the point where the immune system could control the infection without antiretroviral drugs: a “functional cure.”
    Other compelling challenges in HIV/AIDS research relate to developing, assessing and validating new approaches to blocking HIV transmission. These approaches include:
    • Reducing HIV transmission by reducing viral load—Increase the number of HIV-infected people on antiretroviral drugs to reduce the amount of virus in their blood, benefiting their health and making them less likely to transmit the virus to others.
    • Pre-exposure prophylaxis with antiretroviral drugs (PrEP)—Antiretroviral therapy administered to high-risk, uninfected people to protect them from HIV infection.
    • Topical microbicides—Creams, gels or other substances for application to the vagina or rectal mucosa to prevent HIV infection.
    • Preventing or treating co-infections—Preventing or treating diseases such as malaria, tuberculosis, parasitic diseases or other sexually transmitted infections that may increase a person’s susceptibility to HIV or the likelihood that he or she will transmit HIV to others.
    • HIV vaccines—A vaccine that prevents HIV infection or slows the course of disease, benefiting the individual and potentially reducing his or her infectiousness to others.
    The authors conclude that it is essential to sustain a robust HIV/AIDS research agenda to develop these interventions, which have the potential to be truly transforming. Without such tools, the scope and burden of the HIV pandemic will continue to grow.
    ARTICLE: AS Fauci and GK Folkers. Investing to meet the scientific challenges of HIV/AIDS. Health Affairs 28(6):1629-41; DOI 10.1377//hlthaff.28.6.1629 (2009).
    www3.niaid.nih.gov/news/newsreleases/...
  20. [verwijderd] 18 november 2009 19:30


    NOVEMBER 17, 2009, 1:30 P.M. ET.Common Cold Virus Linked to Failure of HIV Vaccine Test

    Associated Press
    WASHINGTON -- The failure of an experimental AIDS vaccine trial two years ago may have been caused by the common cold virus.

    The vaccine was intended to block the spread of HIV, which causes AIDS. But the test was canceled after volunteers who got the shots were more likely to become infected than those who got a dummy shot.
    ................

    Copyright © 2009 Associated Press
    online.wsj.com/article/SB125840220390...
252 Posts
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