Crucell Terug naar discussie overzicht

draadje tuberculose

1. [verwijderd] 2 april 2009 09:14

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   quote:

   gocrucellgo schreef:

   [quote=wilb52]
   Ron
   long time no see!
   [/quote]
   We zijn aardig op weg naar de 16...
   

   Dat zegt me helemaal niets meer op korte termijn, want daarna kun je weer gewoon naar 14..., met dit manipulatieve aandeel.
   Is nu al bijna 2 maanden :
   Vleesch noch Visch
2. [verwijderd] 2 april 2009 11:55

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   wilb52 schreef:
   
   gocrucellgo schreef:
   
   wilb52 schreef:
   
   Ron
   long time no see!
   
   We zijn aardig op weg naar de 16...
   
   Dat zegt me helemaal niets meer op korte termijn, want daarna kun je weer gewoon naar 14..., met dit manipulatieve aandeel.
   Is nu al bijna 2 maanden :
   Vleesch noch Visch
   
   Onzin, Crucell is duidelijk een nog vrij rond zwemmende visch. De netten zijn echter al gespannen, en zijn vrije dagen geteld. Wie durft zal veel vangen!
3. [verwijderd] 2 april 2009 12:12

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   quote:

   wilb52 schreef:

   [quote=gocrucellgo]
   [quote=wilb52]
   Ron
   long time no see!
   [/quote]
   We zijn aardig op weg naar de 16...
   [/quote]
   
   Dat zegt me helemaal niets meer op korte termijn, want daarna kun je weer gewoon naar 14..., met dit manipulatieve aandeel.
   Is nu al bijna 2 maanden :
   Vleesch noch Visch
   

   Straks moeten we wilb ook nog gaan waxen!
4. [verwijderd] 2 april 2009 12:21

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   BTW: willemn ("de zwijger") krijgt toch maar mooie kansen om putjes 15 jun09 bij te kopen aan een spotprijsje.
5. flosz 2 april 2009 12:54

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   Via de site van “Steve’s” IDRI.
   www.idri.org/index.php?name=press&sub...
   
6. flosz 6 april 2009 08:10

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   High unmet needs remain for TB in the developing world
   06 Apr 2009
   Public-private partnerships drive search for novel TB vaccines
   Experts agree that the introduction of an efficacious TB vaccine holds the greatest promise for achieving TB control. There are several drawbacks to the only currently available TB vaccine, bacillus Calmette-Guerin (BCG). While this live vaccine protects against severe childhood forms of disease, including milliary and extrapulmonary TB and the often fatal TB meningitis, it does not prevent the establishment of primary infection or reactivation of latent TB, with the latter condition being the main source of mycobacterial spread in the community. As a consequence, a novel vaccine which targets pulmonary TB represents the single most important unmet need in TB, particularly in the developing world. Given that there is currently no biomarker of treatment response for TB, there is also a large unmet need for rapid and inexpensive diagnostics. These could reduce the length of clinical trials and improve the ability to assess the efficacy of vaccines.
   A number of challenges have hampered vaccine development for TB. These include safety issues, particularly in the HIV-infected population, large and lengthy clinical efficacy trials, selection of appropriate immunization strategies, and identification of the most suitable type of vaccine. In addition, the decline in TB incidence in the developed world has reduced the commercial attractiveness for pharmaceutical companies, resulting in a lack of industry investment in anti-tuberculosis research and a dearth of new drugs and vaccine candidates.
   Nonetheless, drug development has been re-invigorated in recent years. After a long period of inactivity, a number of vaccines for TB have reached clinical stages of development, with public-private partnerships being a key driver. The Aeras Global TB Vaccine Foundation, which receives funding from a number of donors such as the Bill and Melinda Gates Foundation, is currently working on six candidate vaccines. Aeras is developing these through collaborations with companies like Crucell, GlaxoSmithKline, Sanofi Pasteur and several others. Several novel vaccines and strategies are being investigated for both prevention and treatment of TB, addressing the limitations of the current BCG vaccination. The first and most widely used approach is replacement of BCG with a more effective vaccine that provides lasting protection. Other strategies include the development of a new vaccine for adolescents/adults that prevents adult pulmonary TB, and the development of immunotherapeutic vaccines. Given the wide use of the BCG vaccine, particularly in the developing world, a prime-boost strategy using a new TB vaccine candidate to boost the BCG vaccine is currently considered the best way to test and introduce new TB vaccines into endemic countries. The vaccine candidates include BCG strains that have been genetically manipulated to express immunodominant antigens (recombinant BCG) and several non-living vaccines (i.e. subunit; DNA; and viral vector vaccines).
   www.pipelinereview.com/content/view/2...
   
7. flosz 23 april 2009 09:34

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   New TB Vaccine Candidate Enters Phase IIb Proof-of-Concept Trial in South Africa
   Vaccine Candidate is the most clinically advanced of a new generation of vaccines under development to combat the TB epidemic
   
   OXFORD, UK; ROCKVILLE, MD, USA; CAPE TOWN, ZA - 22 April 2009 - The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd. ("the Consortium"), Isis Innovation Ltd., the Wellcome Trust and the University of Cape Town (UCT) announce today the start of a Phase IIb proof-of-concept clinical trial of a promising new TB vaccine developed at the University of Oxford called MVA85A/AERAS-485. The study will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) of UCT in the Western Cape Region from its study site 100 Km from Cape Town in Worcester, South Africa. This study, which has been approved by the Medicines Control Council of South Africa, will test MVA85A/AERAS-485 in approximately 2,784 children under one year of age all of whom have received BCG at birth. It is expected that the trial will generate important safety, immunogenicity and preliminary efficacy data about the vaccine candidate. This is the first proof-of-concept trial of a new preventive TB vaccine in infants in more than 80 years.
   
   Tuberculosis kills 1.8 million people per year and more than two billion people worldwide are infected with TB - approximately one out of every three people on the planet. New vaccines are urgently needed as part of the global response to TB. Bacille Calmette-Guérin (BCG) is currently the only available vaccine against TB. BCG, which is administered to infants throughout the developing world and in certain countries in the developed world, provides some protection against pediatric TB. However, BCG provides only variable protection against pulmonary tuberculosis, which accounts for most of the worldwide disease burden.
   
   "The world desperately needs new and better approaches to combat TB," said Dr. Marcos Espinal, Executive Secretary of the Stop TB Partnership. "The advancement of a new TB vaccine candidate to this stage is an exciting development for all of us who seek to end this terrible epidemic."
   
   This new vaccine candidate is intended to augment the response of T-cells already stimulated by the BCG vaccine. Previous clinical trials of the vaccine in adults have demonstrated consistently high cellular immune responses in those who received the MVA85A/AERAS-485 vaccine candidate following vaccination with BCG.
   
   "The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort," said Jerald C. Sadoff, MD, President & CEO of the Aeras Global TB Vaccine Foundation. "There is still a long road ahead, but this marks an important milestone toward the goal of a more effective TB vaccine."
   
   The Aeras Global TB Vaccine Foundation is working with the Consortium to develop MVA85A/AERAS-485 with additional funding from the Wellcome Trust. The vaccine candidate was originally developed at the University of Oxford by Dr. Helen McShane, a Wellcome Trust Senior Clinical Research Fellow, working with Dr. Sarah Gilbert, a Reader in Vaccinology and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow. It was licensed by Isis Innovation, the University's technology transfer company to the Oxford-Emergent TB Consortium in July 2008. The vaccine has been awarded orphan drug status by the European Medicines Agency (EMEA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.
   
   "We believe this is the most exciting advance in the field of TB vaccines for over 80 years," said Dr Helen McShane of the Jenner Institute, University of Oxford, "and is a testament to the commitment shown by the partners and funders involved. We have shown that this vaccine is safe and stimulates strong immune responses. This trial will hopefully show that the vaccine can protect people from getting TB and enable the global community to begin to control this devastating disease."
   
   Professor Gregory Hussey, Director of SATVI, says that the announcement of this study brings a message of hope: "We are testing the vaccine in an area burdened by one of the highest incidence rates of TB in the world, in a community most likely to benefit from its success. The study strengthens our commitment to stop TB."
   
   "This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world's deadliest diseases," said Fuad El-Hibri, Chairman and Chief Executive Officer at Emergent BioSolutions.
   www.aeras.org/newscenter/news-detail....
   
8. flosz 28 april 2009 14:10

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   Published: 14:00 28.04.2009 GMT+2 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562
   
   Aeras and Crucell Announce Start of TB Infant Study in South Africa
   Leiden, The Netherlands / Rockville, MD, USA - April 28, 2009 - Dutch biopharmaceutical company Crucell N.V. (Euronext, Nasdaq: CRXL; Swiss Exchange: CRX) and the Aeras Global TB Vaccine Foundation today announced the start of a Phase I clinical trial in infants of the jointly developed tuberculosis (TB) vaccine candidate, AERAS-402/Crucell Ad35. This is the first clinical trial designed to test this vaccine candidate in infants.
   
   The Phase I study of AERAS-402/Crucell Ad35 will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) in the Western Cape region of South Africa. The main objective of the study will be to test the safety of the TB vaccine candidate in infants previously vaccinated with the Bacille Calmette-Guérin (BCG) vaccine, which is currently the only vaccine licensed to help prevent TB. The AERAS-402/Crucell Ad35 vaccine candidate has previously been tested for safety in healthy adults in the United States and South Africa, and adults exposed to TB in South Africa and Kenya.
   
   "BCG is the most widely administered vaccine globally, yet there is more TB now than ever before," said Dr. Jerald C. Sadoff, President and CEO of the Aeras Global TB Vaccine Foundation. "We are testing AERAS-402/Crucell Ad35 as a booster vaccine to BCG or to a recombinant BCG to stimulate the body's immune response and improve protection against TB. The AERAS-402/Crucell Ad35 vaccine is inducing the highest CD8 T cell responses in humans we have seen with any TB vaccine."
   
   Fifty-four healthy infants who have not been exposed to TB or HIV will be enrolled in the study.
   
   "We are very pleased that the collaboration with Aeras and SATVI enables us to enter into this new trial," said Dr. Jaap Goudsmit, Crucell's Chief Scientific Officer. "Using Crucell's technologies, we are on a joint mission to develop a new vaccine against TB that could increase the number of people protected from infectious diseases worldwide."
   
   In 2004, Aeras and Crucell began jointly developing this vaccine candidate using Crucell's AdVac® vaccine technology and PER.C6® manufacturing technology. Data from all AERAS-402/Crucell Ad35 trials support the immunogenicity and acceptable safety profile of the TB vaccine candidate at all dose levels evaluated.
   
   AERAS-402/Crucell Ad35 trials
   A first Phase I clinical trial launched in October 2006 in Kansas, USA indicated that the vaccine candidate is safe in healthy adults who have not previously been immunized with BCG in the USA.
   
   Results of a second study, launched in May 2007 in South Africa, were presented at the 'TB Vaccines for the World' conference in April 2008. Preliminary data demonstrated induction of both critical arms of the cellular immune system, CD4 and CD8 immune T-cells, and showed that in those participants who responded, CD8 immune responses were much higher than had ever previously been seen in a TB vaccine study.
   
   A third phase I study in healthy adults in St. Louis, Missouri, USA was launched in December 2007 focusing on the immunogenicity and safety of two AERAS-402/Crucell Ad35 boost doses administered at three to six month intervals after BCG priming in healthy adults. Data from this study indicate that two injections of AERAS-402/Crucell Ad35 are immunogenic; these responses and those seen in South African adult volunteers given BCG around birth are some of the highest CD8 T cell responses ever seen in a TB vaccine study. This immune response is greater than that detected in the absence of BCG prime, supporting the possible utility of AERAS-402/Crucell Ad35 as a booster vaccine. BCG prime alone shows limited immunogenicity.
   
   An ongoing study in St. Louis, Missouri, USA is evaluating a longer prime-boost interval. The study has been fully enrolled and has discovered no safety issues. Immunological data are expected to be available in the first half of 2009.
   
   A Phase I clinical trial of the jointly developed TB vaccine was started in Kenya in October 2008. The study is being conducted by the KEMRI/Walter Reed Project-Kisumu at their Kombewa Clinical Trials Center near Kisumu, in Western Kenya. Its main objective will be to test the safety of the candidate vaccine in BCG-vaccinated adults with or without latent tuberculosis. This study is fully enrolled and is now in its follow-up segment, with no safety issues identified.
   
   In October 2008, enrollment for the first Phase II study of AERAS-402/Crucell Ad35 was started in Cape Town, South Africa. The study is being conducted by the University of Cape Town Lung Institute in conjunction with SATVI. The candidate is being tested in 82 adults who have had active TB. No evidence of an unacceptable safety issue has been found in the study's dose escalation design.
   www.iex.nl/forum/topic.asp?forum=228&...
   
9. flosz 1 mei 2009 12:55

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   Friday, May 1, 2009
   BioWatch: Biotechs ramp up efforts to wipe out TB, malaria
   Aeras opens new plant;
   The Aeras Global TB Vaccine Foundation, a Rockville nonprofit that is developing tuberculosis vaccines, is holding a grand opening Monday of its new 9,000-square-foot manufacturing facility.
   The new plant complements its 6,500-square-foot facility that opened in 2006. Together, they give Aeras the capability to take tuberculosis vaccines under development from cells in the lab to vaccines in vials and capsules, according to spokeswoman Annmarie Leadman.
   "The expansion of our facility will enable Aeras to pursue a promising initiative to deliver vaccines directly into the lungs via aerosol formulation," Leadman said in a statement. "Many of our machines are one-of-a-kind having been customized specifically to Aeras' needs and make this a unique BioSafety Level-2 facility."
   Whiting-Turner of Baltimore was the general contractor on the project, which provided more than 100 construction jobs. Since 2006, Aeras has invested $23 million in its manufacturing facilities.
   A good chunk of that money has come from the Bill & Melinda Gates Foundation, which since 1999 has given Aeras $308.6 million.
   Aeras is the Gates foundation's only nonprofit beneficiary with its own manufacturing facility, Leadman said. The idea is to accelerate development and keep costs low, so that vaccines can be affordable in developing nations.
   Also, Aeras and its partners have launched a phase 2b proof-of-concept clinical trial of a new TB vaccine developed at the University of Oxford (U.K.). The trial will be conducted in South Africa. The patients: about 2,784 babies under 1 year old who have already received another vaccine. The new candidate is intended to enhance the body's response to the previously administered vaccine.
   Aeras' partners are the Oxford-Emergent Tuberculosis Consortium, Isis Innovation, the Wellcome Trust and the University of Cape Town.
   Aeras has also begun a phase 1 trial in South Africa of another vaccine candidate that it has developed with Crucell, a Dutch biopharmaceutical company. That trial will be conducted on 54 healthy babies.
   The incidence of tuberculosis is on the rise. Globally, there were about 9.27 million cases in 2007, up from 9.24 million in 2006, 8.3 million in 2000 and 6.6 million in 1990, according to the World Health Organization. The vast majority of cases were in Asia, with 55 percent, and Africa, with 31 percent. About 1.8 million people died of TB in 2007.
   "The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort," said Jerald C. Sadoff, president and CEO of Aeras, in a statement.
   "This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world's deadliest diseases," said Fuad El-Hibri, chairman and CEO of Rockville biotech Emergent BioSolutions, which is teaming with the University of Oxford on the TB project.
   www.gazette.net/stories/05012009/busi...
   
10. [verwijderd] 4 mei 2009 10:18

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    Upscaling of an Intensified Process for the Production of a Recombinant Ad35 Vaccine using the PER.C6® Cell Substrate
    
    Alfred Luitjens, Senior Scientist, Crucell, Leiden/NL
    
    Crucell and The Aeras Global TB Foundation are collaborating in the development of a recombinant adenovirus (rAd) based Tuberculosis vaccine for which Phase II studies are currently ongoing. The manufacturing process supporting these Phase II studies was developed using the PER.C6® cell substrate. At the productivity of this production process, scale-up to 10,000-liter bioreactor will be required to provide a minimum of 100-200,000,000 doses to assure an immediate global impact on disease burden immediately after licensure.
    Given the uncertainties attendant to the CAPEX commitment required to develop a facility for a 10,000-liter bioreactor process and the unprecedented need to develop a viral vaccine manufacturing process at 10,000L scale under BSL 2 conditions, our approach is to focus on intensification of the rAd35 manufacturing process. Accordingly, we have set as an objective, a 10-20 fold intensification of the Upstream Manufacturing Process to be realized through increases in volumetric productivity.
    This presentation will review our approach to upscale an intensified rAd35 process, focusing on both decreases of process times and increase in productivities.
    
    achema-content2.dechema.de/index.php?...
11. flosz 4 mei 2009 21:43

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    Monday, May 4, 2009, 2:55pm EDT | Modified: Monday, May 4, 2009, 2:56pm
    Aeras Global TB Vaccine Foundation opens plant
    Aeras Global TB Vaccine Foundation has unveiled its new 9,000-square-foot vaccine manufacturing facility, which it said is able to produce enough tuberculosis vaccines to cover worldwide demand.
    The nonprofit, based in Rockville, has opened the second floor of its Research Boulevard building to new manufacturing space that can produce 200 million doses of a new tuberculosis vaccine, a disease that kills 1.8 million people worldwide each year.
    The new facility, which cost $12 million with the new equipment, allows Aeras to purify its vaccine products at a higher level and convert them into either injectable or inhalable forms in up to 5,000 vials worth with each run. Aeras will use the space not only to produce vaccines for its four clinical trials underway, including one launched last month to treat South African infants with Dutch partner Crucell NV, but also to distribute around the world.
    “This is not just pilot production,” said Jerald Sadoff, president and CEO of the Aeras Global TB Vaccine Foundation. “We can make things that can be actually sold.”
    Planned for the past four years, this new space is an expansion of an existing 6,500-square-foot manufacturing facility at the nonprofit. As a result, Aeras said it expects to hire more than 25 more people in the next two years to help run the new facility, a nearly 20 percent jump from its 138-person staff now.
    Aeras, and this new manufacturing space, are largely funded by the Bill and Melinda Gates Foundation.
    
    www.bizjournals.com/washington/storie...
    
12. [verwijderd] 4 mei 2009 23:19

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    Aeras Global TB Vaccine Foundation has unveiled its new 9,000-square-foot vaccine manufacturing facility, which it said is able to produce enough tuberculosis vaccines to cover worldwide demand.
    
    Kijk daar straalt vertrouwen uit
    En hulde aan Bill en Melinda
    
    Een vaccin tegen TB is on his way.
    
    Kus ook van mij bedankt weer Flosz voor je tomeloze inzet.
13. MeawandMoo1 5 mei 2009 19:03

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    Aeras Global TB Vaccine Foundation verwacht in 2009
    3 phase II studies met Crucell's oplossing.
    
    www.aeras.org/newscenter/downloads/pd...
    
    2009 Clinical Studies in South Africa
    • Phase IIB proof of concept study of Oxford MVA85A/AERAS-485 in 2,800 BCG vaccinated infants
    
    • Phase I study of AERAS-402/Crucell Ad35 in BCG vaccinated adults
    
    • Phase I study of AERAS-404/HyVac 4 in BCG vaccinated adults
    
    • Phase II study of AERAS-402/Crucell Ad35 in adults with active TB
    
    • Phase II study of AERAS-402/Crucell Ad35 in HIV infected adults
    
    • Phase II study of AERAS-402/Crucell Ad35 in 1400 infants as part of multi-country trial
    
    • Phase I study of GSK M72 in infants
    
14. [verwijderd] 5 mei 2009 19:12

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    quote:

    MeawandMoo1 schreef:

    Aeras Global TB Vaccine Foundation verwacht in 2009
    3 phase II studies met Crucell's oplossing.
    
    www.aeras.org/newscenter/downloads/pd...
    
    2009 Clinical Studies in South Africa
    • Phase IIB proof of concept study of Oxford MVA85A/AERAS-485 in 2,800 BCG vaccinated infants
    
    • Phase I study of AERAS-402/Crucell Ad35 in BCG vaccinated adults
    
    • Phase I study of AERAS-404/HyVac 4 in BCG vaccinated adults
    
    • Phase II study of AERAS-402/Crucell Ad35 in adults with active TB
    
    • Phase II study of AERAS-402/Crucell Ad35 in HIV infected adults
    
    • Phase II study of AERAS-402/Crucell Ad35 in 1400 infants as part of multi-country trial
    
    • Phase I study of GSK M72 in infants
    
    

    Met een plaatje

    Bijlage:
15. flosz 19 mei 2009 09:37

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    quote:

    flosz schreef:

    Monday, May 4, 2009, 2:55pm EDT
    Aeras Global TB Vaccine Foundation opens plant
    

    Filmpje erbij...
    
    Applying 21st Century Solutions to a Centuries Old Disease
    In Rockville, Maryland, US Aeras Global TB Vaccine Foundation opens its BSL-2 Vaccine Manufacturing facility. Including the capacity to produce vaccines delivered directly to the lungs via aerosol, the manufacturing facility represents a major advance in the effort to develop and deliver new TB vaccines worldwide. It gives Aeras the capacity to deliver 200 million doses of bulk vaccine, the estimated worldwide need for a new TB vaccine.
    www.globalhealthtv.com/news/new_tuber...
    
    Biotech nonprofits immune to recession — for now
    Vandana Sinha | WASHINGTON BUSINESS JOURNAL
    
    A local vaccine maker is doing the unthinkable in a recession. It's hiring.
    
    And expanding its manufacturing quarters.
    
    And starting new clinical trials.
    
    Most astoundingly, it's not the only one.
    
    Aeras Global TB Vaccine Foundation is among a select group of drug-developing nonprofits - or drug-developing companies primarily funded by not-for-profits - that is growing amid a shrinking biotech sector. Focused for the most part on the world's most rampant and yet neglected diseases, entities such as Aeras, Sanaria Inc. and Sabin Vaccine Institute have been able to buck a financing crisis that has brought many of the area's most prominent biotech players to their knees.
    
    At least for now. Even those now claiming success worry whether those grants and donations can continue as stocks keep sliding.
    
    "So far our funders have been very farsighted and have not let the economic downturn affect their support," said Jerry Sadoff, president and CEO of Rockville-based Aeras, which develops tuberculosis vaccines. "We don't know how long that will stay. So we're worried too."
    
    In the meantime, Aeras is growing. The nonprofit recently unveiled 9,000 square feet and $12 million worth of new manufacturing space at its headquarters, requiring it to hire another 25 people to help run the facility in the next two years. With four TB vaccines in clinical trials now, including one launched in South Africa last month, Aeras plans to add another two human trials for this year.
    
    Sabin moved two months ago into new headquarters three times its original size, now on the George Washington University campus. It has six open positions, and expects to be at 35 people by year end, roughly double its staff from last year. PATH Malaria Vaccine Institute, in Bethesda, is linking with Rockville-based Sanaria to launch its first human trials of a malaria vaccine. Sanaria hired two more staffers in the last week and is planning another modest bump in head count, all the while mapping out a potential Maryland site for a new manufacturing facility in the next two years. U.S. Pharmacopeial Convention, a Rockville nonprofit standards-setting group for pharmaceuticals, is hunting for scientists and seeing increased sales of its guides.
    
    "We're not recession-proof," said spokeswoman Laura Provan. "But we're resilient."
    
    And most are backed by multi-year grants from loyal funders, from foreign governments to health organizations, whose eyes aren't always glued to the commercial prize - a key factor for many of these groups. Building new, or sometimes the only, treatments for the planet's poorest is an industry niche few customers can afford and fewer for-profits pursue.
    
    "We're mission-driven and our funders are mission-driven," said Brian Davis, chief operating officer at Sabin. "If the mission appears to be going in a successful pattern, then they don't believe they need to pull back support."
    
    It's no different for those few for-profits. Sanaria and Sequella Inc. of Rockville relied on philanthropic and federal grants - long considered more a burden than blessing on Wall Street - to pay for new clinical trials for malaria and tuberculosis treatments launched in the past month.
    
    Indeed, a common denominator among most of these groups is a foundation created by a man not bothered with returns on investment - the Bill and Melinda Gates Foundation. The Seattle nonprofit has given nearly $350 million to Aeras, Sabin and Sanaria alone, ranging from one-half to 90 percent of their total intake to date, causing some to dub themselves "Gatelets."
    
    But even the most optimistic aren't sure how long their good fortunes will last. Aeras said it can only continue as planned with as much as $30 million from the still-unconfirmed USAID agency.
    www.aeras.org/newscenter/presscoverag...
    
16. flosz 20 mei 2009 09:34

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    TB Vaccine Gets Its Groove Back
    ScienceDaily (May 19, 2009) — A team of Vanderbilt University Medical Center investigators has cracked one of clinical medicine's enduring mysteries – what happened to the tuberculosis vaccine. The once-effective vaccine no longer prevents the bacterial lung infection that kills more than 1.7 million people worldwide each year.
    www.sciencedaily.com/releases/2009/05...
    
    Reducing the Activity and Secretion of Microbial Antioxidants Enhances the Immunogenicity of BCG
    www.plosone.org/article/info%3Adoi%2F...
    
17. flosz 5 juni 2009 08:26

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    Major drug pharmaceutical companies GlaxoSmithKline, Sanofi-Aventis and Crucell are now also testing TB vaccines, although there is little incentive to develop an unprofitable vaccine.
    
    **********
    South Africa leads hunt for killer TB vaccine
    Trials for new TB vaccine to start in SAfrica in July
    
    * SAF with highest TB rate, reversing yrs of underinvestment
    
    * SAfrica government to target inequalities in health care
    SAfrica government to target inequalities in health care
    
    By Wendell Roelf
    
    WORCESTER, South Africa, June 5 (Reuters) - Baby Hisinawa is permanently semi-comatose after TB spread to his brain, his board-stiff body shivering as a doctor pushes a rubber tube down his nose to clear away thick phlegm choking him.
    
    Last December, the chubby two-year-old South African was talking and laughing. Now he has limited use of all four limbs and cannot swallow.
    
    Hisinawa is a severe example of the debilitating symptoms of tuberculosis, which kills more people than any other treatable infectious disease. Trials for a new vaccine start in South Africa in July.
    
    Scientists across the world are seeking a new vaccine against the contagious lung disease, which is largely under control in developed countries but still haunts the poor in the developing world. Up to one in three people have it globally.
    
    "The world needs a new TB vaccine because the current one is not really effective in terms of preventing TB and that is manifest in the context of an increasing epidemic," Gregory Hussey, director of the South African TB Vaccine Initiative (SATVI) told Reuters.
    
    With more resources and research committed by international and philanthropic organisations like the World Bank and the Bill and Melinda Gates Foundation, optimism for a new TB vaccine has reached heights last seen when the current TB vaccine, Bacille Calmette-Guerin (BCG), was developed in the 1920s.
    
    The most clinically advanced of the nine vaccine candidates -- called MVA85A -- will be tested in South Africa next month among 2,874 children under the age of one. Researchers hope to register a new anti-TB vaccine by 2015.
    
    "All of the clinical trials conducted to date with this vaccine (MVA85A) have shown that it is safe and it stimulates high levels of the type of immune response we believe is protective against tuberculosis," the vaccine inventor Dr Helen McShane of the University of Oxford, told Reuters.
    
    The World Bank, which focuses on controlling TB by identifying and curing infectious patients, has said financial support for its treatment would bring an estimated economic gain of around $1.6 trillion between 2006 and 2015.
    
    Without financial intervention, the economic burden of TB in badly hit countries like China could reach up to $1.2 trillion between 2006 and 2015, the World Bank said. Global efforts have been ramped up to meet a United Nations Millennium Development Goal of halving the global TB infection rate by 2015.
    
    STALKING THE POOR
    
    South Africa is a good place to start: a high rate of infection coupled with the world's largest AIDS epidemic, where close to an eighth of the population are HIV positive, makes it particularly vulnerable.
    
    The World Health Organisation has said the AIDS virus and TB form a lethal combination, each speeding the other's progress. TB is the leading cause of death in AIDS sufferers.
    
    "My friend has TB and I've seen what it does to her," said Esmerenthia Cupido, 35, a resident of the town of Worcester, 100km (63 miles) north of Cape Town, where one of the vaccines will be tested under SATVI, which is assessing four TB vaccine candidates in the global pipeline.
    
    "She coughs terribly and is getting very thin. She also lost two of her brothers to the disease, but likes to party and drink. She doesn't want to listen," Cupido told Reuters at the Brewelskloof hospital in Worcester.
    
    "Tering" as it is known in the local Afrikaans patois, stalks the poor. A lack of proper nutrition, cramped living conditions and substance abuse aid TB's spread.
    
    In South Africa a visit to the local corner shop or popular neighbourhood drinking spot can be a dangerous gamble, should an infected adult sneeze or cough. The World Health Organisation has said South Africa has the world's highest TB incidence rate at 948 infections for every 100,000 people.
    
    INEQUALITY
    
    The government said on Wednesday it would step up measures to improve health care in Africa's strongest economy.
    
    "We have set ourselves the goals of reducing inequalities in health care ... and step up the fight against the scourge of HIV and AIDS, TB and other diseases," South Africa's president Jacob Zuma said in his first state-of-the-nation address.
    
    TB, which has infected people for thousands of years according to the Global Tuberculosis Institute at the New Jersey Medical School, kills around 1.8 million people globally each year. Children and young adults are most vulnerable.
    
    In the 21st century it has swamped developing countries across Africa and Asia, overwhelming fragile health care systems. It is firmly enmeshed in the social fabric of Worcester.
    
    "About four months ago I saw someone in our street die from TB. He got thin and started vomiting blood. When he coughed, chunks of blood came with it", Monique Wilson, 26, said as she cradled six-month-old Mercedi. "That scared me and I decided to take my baby for vaccination."
    
    The TB bacterium commonly affects the lungs, but can also move through the blood to other organs and the bones. When the brain is affected, as with baby Hisinawa, patients die or suffer serious disabilities.
    
    The July tests will be the first concept trial of a new preventative TB vaccine for infants in close to 90 years, and will be used as a booster to the BCG shot if found to be successful.
    
    Major drug pharmaceutical companies GlaxoSmithKline, Sanofi-Aventis and Crucell are now also testing TB vaccines, although there is little incentive to develop an unprofitable vaccine.
    
    "Most of the market is in developing countries which might not be able to afford an expensive vaccine," said Dr Tony Hawkridge, Head of the Aeras Global TB Vaccine Foundation's Africa office.
    
    "It's never going to be a Viagra or one of those multi-billion dollar products which rockets a company into the ranks of the very rich," he said. (Reporting by Wendell Roelf; Editing by Farah Master and Michael Kahn)
    www.reuters.com/article/latestCrisis/...
    
18. flosz 6 juni 2009 19:02

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    The new vaccine is produced by Dutch biopharmaceutical company Crucell N.V.
    _______________
    6.04.2009
    SOUTH AFRICA: TB vaccine trials for babies
    IRIN PLUSNEWS
    JOHANNESBURG, 4 June 2009 (PlusNews) - A new trial to test the efficacy of a tuberculosis (TB) booster shot for babies is about to start in South Africa, but when your subjects are too young to eat solids, the challenge rises to a new level.
    
    Almost 2,800 infants will participate in the two-year trial, in which researchers from the South African Tuberculosis Vaccine Initiative (SATVI) hope to prove that a new vaccine can act as a booster shot to improve the efficacy of the only existing inoculation against TB, the Bacille Calmette-Guerin (BCG) vaccine, in use for nearly 90 years.
    
    BCG has become a standard part of national immunisation programmes in many countries, including South Africa, but it does not guarantee protection against the most common form of TB, which attacks the lungs. An effective TB vaccine could help save some of the two million people who die annually from the disease, a quarter of whom are co-infected with HIV.
    
    The vaccine has been tested in HIV-infected adults in South Africa, the UK and Senegal, but because this will be the first test in infants, only HIV-negative infants will be enrolled.
    
    According to Michele Tameris, study manager for the trial, the vaccine has already been administered to infants in Gambia, with no side-effects other than a brief period of mild discomfort, and the irritation and swelling at the injection site usually associated with childhood immunisations.
    
    Caution: Baby on Board
    
    Dr Glenda Grey, co-director of the Perinatal HIV Research Unit at Witwatersrand University, which participated in South Africa's first human clinical trial for an HIV vaccine in 2003, said oversight bodies demanded a higher burden of proof when children and infants were included in studies.
    
    "Ethics committees must also ensure that infants don't find themselves in a more vulnerable position than they already are because they participated in a trial; you have to minimise the harm and maximise the benefits," she said.
    
    "Does a child benefit from being in the study? They often do. The nice thing ... [is that] any illness is diagnosed much earlier and [they] get treatment, whereas ... [other children] may not be able to get to a clinic, may be misdiagnosed or get poor treatment," said Grey.
    
    Consent is always a crucial issue. "You also have to make sure the parents or caregivers understand the informed-consent process, the risks and benefits, that a vaccine may or may not work, and that their child is contributing to science."
    
    Ethics in practice
    
    The town of Worcester, in the winelands of Western Cape Province, is one of three towns participating in the SATVI trial. HIV and TB co-infection has been the most significant cause of premature death in the province since 2007.
    
    Tameris said the blood samples taken in this study would be much smaller, and would also be taken less often, because drawing adult-sized samples from pint-sized participants could mean risking anaemia or other illnesses.
    
    "You have to work out the absolute minimum sample you need, down to microlitres. Babies are very sweet and cute, but it's not always easy when they become distressed and resent having to be held tightly to have blood taken," she said.
    
    Blessing in disguise
    
    The Department of Health estimated that almost 90 percent of children under the age of one were immunised in 2008. "We have very high immunisation rates in South Africa so we have a culture of immunising our children and, in that sense, vaccine trials are easier and more understandable than drug trials to many people," Grey noted.
    
    Although there have been concerns that the legally mandated R150 (US$19) given to participants per clinic visit could provide an incentive, Linda Sibeko, who lives in Worcester and is a member of the study's interim community advisory board, said parents saw it as a way of learning more about TB. "People are welcoming it. We explained ... and now everyone wants to be involved."
    www.aeras.org/newscenter/presscoverag...
    
    New TB Trial In South Africa To Test Infants
    Clinical trials to test a new tuberculosis (TB) booster injection are about to begin in rural South Africa. The trials are unusual in that the test subjects will be infants.
    Researchers from the South African Tuberculosis Vaccine Initiative (SATVI) hope to prove the new vaccine can increase the effectiveness of the Bacille Calmette-Guerin (BCG) vaccine, which has been used for nearly 90 years, according to PlusNews.
    
    The traditional BCG vaccine does not provide protection against the most common form of TB, which attacks the lungs. Close to 2,800 infants are to take part in the two-year test programme, which is being conducted jointly by SATVI and the University of Cape Town. The new vaccine is produced by Dutch biopharmaceutical company Crucell N.V.
    
    TB often attacks HIV patients and has become more widespread in South Africa as a result of the AIDS epidemic here.
    
    Co-director of Witwatersrand University’s Perinatal HIV Research Unit, Dr Glenda Grey, said the burden for ethical treatment was higher than otherwise in the case of children and babies:
    Ethics committees must also ensure that infants don't find themselves in a more vulnerable position than they already are because they participated in a trial. You have to minimise the harm and maximize the benefits.
    
    Concerns have been raised over the $19 fee given to the parents of the infants. The tests are to be carried out in one of South Africa’s poorest areas, around Worcester in the Eastern Cape.
    
    TB has become a major medical problem in South Africa partly because of its appearance together with HIV, but also because rural patients tend not to complete their prescribed courses of medicines. Instead, once they feel better, they stop, often to find they have become victims of Multiple Drug Resistant (MDR) TB, which is very difficult to treat, let alone cure.
    www.digitaljournal.com/article/273693
    
19. flosz 16 juni 2009 16:42

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    Pacific Health Summit
    Seattle USA
    June 16-18, 2009
    The goal of the Pacific Health Summit is to connect science, industry, and policy for a healthier world. Every June we invite top decision-makers in science, policy, industry, medicine, and public health to Seattle to discuss how to realize the dream of a healthier future through the effective utilization of scientific advances combined with appropriate policies for prevention, early detection, and early treatment of disease. And each year we focus our discussion on an issue of critical importance; in 2008, the Summit addressed the challenge of global nutrition, and in 2007 the theme was pandemic influenza.
    In 2009, we will take up the important topic of multidrug-resistant tuberculosis (MDR-TB) as a major global health threat. The world faces 500,000 cases of MDR-TB each year—we are knowingly committing to a future epidemic of untreatable disease if we fail to act now. Our challenge is to strengthen existing approaches to basic TB control and MDR-TB management, and break through existing bottlenecks around technology development and treatment implementation in both developed and developing country health systems. The 2009 Summit in June provides the opportunity for top leaders to come together to tackle how science, industry, and policy can accelerate the uptake of innovation to address this emerging global health threat.
    The Summit is a year-round process. In addition to the June meeting, the Summit provides an ongoing forum for world leaders to improve health by working together to grapple with problems and solutions, share best practices, and forge effective collaborations.
    www.pacifichealthsummit.org/default.aspx
    
    Steve Davis is ook aanwezig:
    www.pacifichealthsummit.org/downloads...
    
    Seattle’s Pacific Health Summit, the “Davos” of Global Health, Zeroes in on Tuberculosis
    Luke Timmerman 6/16/09
    Movers and shakers in global health—including a lot of people not named Bill & Melinda—will be buzzing around the Seattle waterfront this week for what some people like to call the “Davos” of global health.
    Like the World Economic Forum in Davos, Switzerland—another picturesque setting with mountains and water nearby—the Pacific Health Summit is an invitation-only annual conference of about 250 world leaders in science, politics, and business. This year, they are gathering to brainstorm about how to put a dent in one of the world’s deadliest infectious diseases: tuberculosis.
    The list of power brokers appearing on the docket includes: Margaret Chan, director-general of the World Health Organization; Chris Viehbacher, CEO of drug and vaccine giant Sanofi-Aventis; Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases; and Paul Farmer, founding director of Partners in Health, the famed physician to people in poor countries. Big Pharma will be well-represented by the likes of Merck, GlaxoSmithKline, Johnson & Johnson, Bayer, and others.
    The main theme of discussion, TB, rarely captures the attention of the masses, like, say, swine flu does. But it’s at least as worrisome, and it’s not going away. The disease, caused by a bacterial invader that attacks the lungs, is characterized by a chronic cough that makes it especially contagious. There is no vaccine, diagnostics aren’t very accurate, and no new drug has been developed in decades, as Farmer put it in a recent appearance in Seattle. That adds up to a pretty grim outlook for a lot of people. About one in three people on Earth (2 billion cases) are estimated to be infected, and TB kills 1.5 million people a year—ranking it right up there with HIV and malaria as one of the world’s leading killers.
    tinyurl.com/m6dqc3
    
20. aossa 17 juni 2009 13:07

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    Unique Collaboration Between TB Alliance And Tibotec to Accelerate Tuberculosis Drug Development Collaboration will focus on the development of TMC207 and the discovery of new drugs to treat tuberculosis
    
    6/17/2009
    TB Alliance Announces Four Drug Discovery Collaborations
    
    [Seattle, WA] A new landmark collaboration between the Global Alliance for TB Drug Development (TB Alliancea not-for-profit, product development partnership, and Tibotec Inc., (Tibotec), a global pharmaceutical company, has been announced today at the Pacific Health Summit in response to the urgent need to accelerate the discovery and development of new drugs to fight tuberculosis (TB).
    
    The two organizations will share their expertise and resources in the development of TMC207, which could become the first TB drug with a new mechanism of action in 40 years. The interim data from an ongoing Phase II study of TMC207 were recently published in the New England Journal of Medicine. In the placebo-controlled study of 47 patients with multidrug-resistant TB (MDR-TB), it was found that 48 percent of patients receiving TMC207 in combination with standard treatment converted to negative sputum culture after eight weeks compared with 9 percent of those who received placebo and standard treatment.
    
    The collaboration will maximize the expertise and resources from both the public and private sectors with the intent to improve the treatment of one of the world's oldest and most deadly diseases. Increased efforts and resources to develop new and improved TB drugs are sorely needed. Among infectious diseases, tuberculosis is the second most common cause of adult deaths worldwide[i]. The World Health Organization (WHO) estimates approximately one-third of the world's population is infected with Mycobacterium tuberculosis (M.tb), the bacillus that causes TBii, and the disease is responsible for nearly 5,000 deaths per day, worldwide[ii]i. MDR-TB, which is characterized by resistance to at least two of the most powerful medicines in today's standard, four-drug regimen for drug-susceptible TB, is of particular concern given the rapid rise in the number of cases throughout the world and the difficulties in treating it. There were an estimated 510,000 incident casesIV and 130,000 fatalities due to MDR-TB in 2007V. The Pacific Health Summit is focusing on MDR-TB at this year's conference because of the growing public health threat it poses.
    
    "We see tremendous potential in this collaboration and in the future of TMC207 as part of a critically-needed new TB regimen," said Dr. Mel Spigelman, TB Alliance President and CEO. "Since the TB Alliance was founded, we have assembled the largest pipeline of new TB drugs in history, but this progress is only possible with the commitment of our partners. Tibotec has tremendous scientific prowess, a commitment to fighting infectious diseases, and is an essential long-term partner in our fight to end one of the greatest epidemics of our time."
    
    Under the terms of the agreement, Tibotec will continue to develop TMC207 for the treatment of MDR-TB, and on approval, will establish an access program to ensure the compound reaches those in developing countries who are in need. The agreement grants the TB Alliance a royalty-free license for the worldwide development and access to TMC207 in the field of drug-susceptible TB. In addition, Tibotec will collaborate with the TB Alliance on a discovery research program to identify new compounds for the treatment of TB. The rights for the newly discovered compounds for the treatment of tuberculosis will belong to the TB Alliance under a royalty free license. Costs for the development of TMC207 will be shared.
    
    "To make a meaningful contribution to the global fight against TB, we knew we had to take a novel approach. Our collaboration with the TB Alliance represents a major step forward in the fight against TB as the two organizations combine their expertise and resources in the quest to make new TB treatments available," said Dr. Paul Stoffels, Global Head of Pharmaceutical Research and Development, Johnson & Johnson. "With MDR-TB becoming a growing, global health threat, and hundreds of thousands of unnecessary deaths from drug-susceptible TB occurring, we are committed to accelerating the development of new drug regimens for tuberculosis."
    
    This announcement marks the first collaboration initiated by the newly created Tibotec Global Access and Partnerships Program. The program is creating a sustainable portfolio of medicines - both marketed and in development - that are designed to address major health challenges in resource-poor countries. Ben Plumley, Vice President of Global Access and Partnerships said, "The future of successfully tackling neglected diseases, such as TB, will be through joint development initiatives between companies and product development partnerships, such as the one we are announcing today with the TB Alliance."
    
    Product development partnerships (PDPs), such as the TB Alliance, build partnerships linking the public, private, academic, and philanthropic sectors. The TB Alliance combines the research and development proficiency of its own staff with the skills and resources of its partners to streamline and optimize TB drug development.
    
    TMC207
    
    TMC207 was discovered by scientists at Janssen Pharmaceutica N.V., which signed the collaboration agreement with the TB Alliance, and is being developed by its affiliate Tibotec. In vitro studies show that it is highly active against Mycobacterium tuberculosis (M.tb). TMC207 has a unique mechanism of action targeting adenosine triphosphate (ATP) synthaseVI, which M.tb, requires to generate its energy supply. Currently, TMC207 is being studied in a Phase II clinical trial in people with MDR-TB. The safety and efficacy of TMC207 has not yet been established.
    
    Global Alliance for TB Drug Development
    
    The TB Alliance is a not-for-profit, product development partnership accelerating the discovery and development of new TB drugs that will shorten treatment, be effective against susceptible and resistant strains, be compatible with antiretroviral therapies for those HIV-TB patients currently on such therapies, and improve treatment of latent infection.
    
    Working with public and private partners worldwide, the TB Alliance is leading the development of the most comprehensive portfolio of TB drug candidates in history. It is committed to ensuring that approved new regimens are affordable, adopted and available to those who need them.
    
    The TB Alliance operates with funding from the Bill & Melinda Gates Foundation, the Netherlands Ministry of Foreign Affairs (DGIS), the United Kingdom Department for International Development (DFID), and the United States Agency for International Development (USAID).
    
    Tibotec Inc.
    
    Tibotec Inc., based in Yardley, Pa., USA, is a pharmaceutical research and development company. The Company's main research and development facilities are in Mechelen, Belgium with offices in Cork, Ireland. Tibotec is dedicated to the discovery and development of innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet medical need.
    
    vervolg: www.tballiance.org/newscenter/view-br...