Corixa - Medikament gegen Malaria (mit GSK) - 500 Beiträge pro Seite
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Meldung geisterte heute durch deutsche Presse, ohne dass CRXA erwähnte wurde, doch hinter dem Impfstoff steckt ein Hilfststoff (Adjuvant) von CRXA:
Public-Private Partnership Leads to Scientific Breakthrough in Development of Malaria Vaccine Containing Corixa`s MPL Adjuvant
Thursday October 14, 6:30 pm ET
Encouraging Results from Largest Pediatric Safety and Efficacy Clinical Trial of Malaria Vaccine in Africa to be Published in The Lancet
SEATTLE & LONDON--(BUSINESS WIRE)--Oct. 14, 2004-- In a proof-of-concept study to be published in the October 16 issue of The Lancet, researchers report that GlaxoSmithKline (GSK) Biologicals` RTS,S/AS02A malaria vaccine candidate containing Corixa`s (Nasdaq:CRXA - News) MPL® adjuvant protected a significant percentage of children against uncomplicated malaria, infection, and even severe forms of the disease for at least six months. This largest malaria vaccine efficacy trial ever conducted in Africa also re-confirmed the vaccine`s safety in one-to-four year old children. Further efficacy studies will be needed before consideration for licensure.
ADVERTISEMENT
The double-blind, controlled trial involved 2,022 children in southern Mozambique and was conducted by the Centro de Investigacao em Saude da Manhica (CISM). GSK Biologicals and PATH`s Malaria Vaccine Initiative (MVI) co-sponsored the trial, which was approved by Mozambique`s Ministry of Health.
" Our results demonstrate the feasibility of developing an efficacious vaccine against malaria," wrote CISM`s Pedro Alonso, MD, Ph.D., lead author of the Lancet article, adding that " ...malaria vaccines could greatly contribute to reducing the intolerable global burden of this disease." Dr. Alonso was the principal investigator of the study and heads the Center for International Health of the Hospital Clinic at the University of Barcelona.
Mozambique`s Minister of Health, Dr. Francisco Songane, said his nation was proud to be a part of such a groundbreaking study. " Malaria is the number one killer of African children. We did this not only for the people of Mozambique, but for the people all over Africa whose health and development suffer greatly from this terrible disease."
" It will still take some years before this vaccine becomes a reality, but the commitment is certainly there," said Jean Stephenne, president and general manager of GSK Biologicals, one of the world`s largest vaccine companies. " We are very encouraged by these results. They demonstrate that a Plasmodium falciparum malaria vaccine based on the circumsporozoite protein is feasible. Such a vaccine could have a major impact on public health. This project demonstrates the power of collaboration between the public and private sectors," he added.
" These findings represent a breakthrough in the science of malaria vaccines," offered Dr. Melinda Moree, Ph.D., director of MVI, a global program created to overcome barriers to malaria vaccine development. " They provide convincing evidence that a vaccine could become part of the world`s efforts to spare children and families from the devastating effects of this disease. This brings us another step closer to a licensed vaccine." In 2000, GSK Biologicals and MVI entered into a partnership to develop the vaccine for children. MVI was started in 1999 with a grant from the Bill & Melinda Gates Foundation, which made this collaboration possible.
According to the study, vaccine efficacy against clinical malaria attacks was 30 percent. Efficacy against primary infection with Plasmodium (P.) falciparum was 45 percent, and efficacy against severe disease was 58 percent. P. falciparum is the parasite that causes the greatest number of cases of malaria in Africa.
" The results of this trial represent a significant scientific advance and an important step forward. In contrast to the previous trials of this vaccine in adults, which suggested that vaccine efficacy was short-lived, protection in these children has lasted at least six months," Dr. Alonso added. Follow-up with the children continues.
A recombinant protein that fuses a part of the P. falciparum circumsporozoite (CS) protein with the hepatitis B surface antigen molecule, RTS,S, has been under development by GSK Biologicals for more than 15 years.
Adjuvants are formulated compounds or additives that boost the body`s immune response when combined with vaccine antigens. In addition to GSK`s malaria vaccine, MPL is present in multiple GSK vaccines now in late stage clinical development.
" There was a lot of skepticism about our approach in the scientific community," recalled Joe Cohen, Ph.D., director, Emerging Diseases, HIV & Therapeutic Vaccines R&D at GSK Biologicals, who is co-inventor of the vaccine. " We`re dealing with a very complex parasite that goes through different life stages in the human host. But we were highly committed and kept at it for over 15 years."
The vaccine is directed against the form of the P. falciparum parasite that is injected by mosquitoes. This form is known as the sporozoite. After immunization, antibodies and white blood cells are produced which can prevent the sporozoite from surviving or from further development in the liver. The vaccine is delivered in a three-dose regimen.
Among infectious diseases, malaria is one of the world`s biggest killers. It is estimated that malaria kills between one and three million people in the world`s poorest countries every year, and more children in sub-Saharan Africa than any other infectious disease.
Due to the need for further studies, a licensed malaria vaccine is not expected to be available before 2010, by when it is projected that half the world`s population, or 3.5 billion people, will be living in areas in which malaria is transmitted. The economic costs of the disease for Africa alone are equivalent to US$12 billion annually.
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing cancer and infectious diseases by understanding and directing the immune system. The Company markets BEXXAR® for the treatment of patients with CD20 positive, follicular, NHL, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.
Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a standalone basis. In addition to BEXXAR, Corixa currently has multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials. The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, with additional operations in Hamilton, Mont., and South San Francisco. For more information, please visit Corixa`s Web site at http://www.corixa.com.
Mozambique`s Ministry of Health has as its mission to promote and preserve the health of the Mozambican population and to promote and provide quality and sustainable health care services, gradually increasing its accessibility to all Mozambicans with equity and efficiency.
The Centro de Investigacao em Saude da Manhica (CISM) is the first peripheral health research centre in Mozambique to undertake medical research into the key health problems in that country. Founded in 1996, CISM was developed under a collaborative programme between the Mozambique Ministry of Health, the Maputo School of Medicine (Universidade Eduardo Mondlane), and the Hospital Clinic of the University of Barcelona (www.hospitalclinic.org) with core funding from the Spanish Agency for International Cooperation. Visit CISM`s web site at www.manhica.org.
Public-Private Partnership Leads to Scientific Breakthrough in Development of Malaria Vaccine Containing Corixa`s MPL Adjuvant
Thursday October 14, 6:30 pm ET
Encouraging Results from Largest Pediatric Safety and Efficacy Clinical Trial of Malaria Vaccine in Africa to be Published in The Lancet
SEATTLE & LONDON--(BUSINESS WIRE)--Oct. 14, 2004-- In a proof-of-concept study to be published in the October 16 issue of The Lancet, researchers report that GlaxoSmithKline (GSK) Biologicals` RTS,S/AS02A malaria vaccine candidate containing Corixa`s (Nasdaq:CRXA - News) MPL® adjuvant protected a significant percentage of children against uncomplicated malaria, infection, and even severe forms of the disease for at least six months. This largest malaria vaccine efficacy trial ever conducted in Africa also re-confirmed the vaccine`s safety in one-to-four year old children. Further efficacy studies will be needed before consideration for licensure.
ADVERTISEMENT
The double-blind, controlled trial involved 2,022 children in southern Mozambique and was conducted by the Centro de Investigacao em Saude da Manhica (CISM). GSK Biologicals and PATH`s Malaria Vaccine Initiative (MVI) co-sponsored the trial, which was approved by Mozambique`s Ministry of Health.
" Our results demonstrate the feasibility of developing an efficacious vaccine against malaria," wrote CISM`s Pedro Alonso, MD, Ph.D., lead author of the Lancet article, adding that " ...malaria vaccines could greatly contribute to reducing the intolerable global burden of this disease." Dr. Alonso was the principal investigator of the study and heads the Center for International Health of the Hospital Clinic at the University of Barcelona.
Mozambique`s Minister of Health, Dr. Francisco Songane, said his nation was proud to be a part of such a groundbreaking study. " Malaria is the number one killer of African children. We did this not only for the people of Mozambique, but for the people all over Africa whose health and development suffer greatly from this terrible disease."
" It will still take some years before this vaccine becomes a reality, but the commitment is certainly there," said Jean Stephenne, president and general manager of GSK Biologicals, one of the world`s largest vaccine companies. " We are very encouraged by these results. They demonstrate that a Plasmodium falciparum malaria vaccine based on the circumsporozoite protein is feasible. Such a vaccine could have a major impact on public health. This project demonstrates the power of collaboration between the public and private sectors," he added.
" These findings represent a breakthrough in the science of malaria vaccines," offered Dr. Melinda Moree, Ph.D., director of MVI, a global program created to overcome barriers to malaria vaccine development. " They provide convincing evidence that a vaccine could become part of the world`s efforts to spare children and families from the devastating effects of this disease. This brings us another step closer to a licensed vaccine." In 2000, GSK Biologicals and MVI entered into a partnership to develop the vaccine for children. MVI was started in 1999 with a grant from the Bill & Melinda Gates Foundation, which made this collaboration possible.
According to the study, vaccine efficacy against clinical malaria attacks was 30 percent. Efficacy against primary infection with Plasmodium (P.) falciparum was 45 percent, and efficacy against severe disease was 58 percent. P. falciparum is the parasite that causes the greatest number of cases of malaria in Africa.
" The results of this trial represent a significant scientific advance and an important step forward. In contrast to the previous trials of this vaccine in adults, which suggested that vaccine efficacy was short-lived, protection in these children has lasted at least six months," Dr. Alonso added. Follow-up with the children continues.
A recombinant protein that fuses a part of the P. falciparum circumsporozoite (CS) protein with the hepatitis B surface antigen molecule, RTS,S, has been under development by GSK Biologicals for more than 15 years.
Adjuvants are formulated compounds or additives that boost the body`s immune response when combined with vaccine antigens. In addition to GSK`s malaria vaccine, MPL is present in multiple GSK vaccines now in late stage clinical development.
" There was a lot of skepticism about our approach in the scientific community," recalled Joe Cohen, Ph.D., director, Emerging Diseases, HIV & Therapeutic Vaccines R&D at GSK Biologicals, who is co-inventor of the vaccine. " We`re dealing with a very complex parasite that goes through different life stages in the human host. But we were highly committed and kept at it for over 15 years."
The vaccine is directed against the form of the P. falciparum parasite that is injected by mosquitoes. This form is known as the sporozoite. After immunization, antibodies and white blood cells are produced which can prevent the sporozoite from surviving or from further development in the liver. The vaccine is delivered in a three-dose regimen.
Among infectious diseases, malaria is one of the world`s biggest killers. It is estimated that malaria kills between one and three million people in the world`s poorest countries every year, and more children in sub-Saharan Africa than any other infectious disease.
Due to the need for further studies, a licensed malaria vaccine is not expected to be available before 2010, by when it is projected that half the world`s population, or 3.5 billion people, will be living in areas in which malaria is transmitted. The economic costs of the disease for Africa alone are equivalent to US$12 billion annually.
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing cancer and infectious diseases by understanding and directing the immune system. The Company markets BEXXAR® for the treatment of patients with CD20 positive, follicular, NHL, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy.
Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a standalone basis. In addition to BEXXAR, Corixa currently has multiple programs in clinical development, including several product candidates that have advanced to and through late stage clinical trials. The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, with additional operations in Hamilton, Mont., and South San Francisco. For more information, please visit Corixa`s Web site at http://www.corixa.com.
Mozambique`s Ministry of Health has as its mission to promote and preserve the health of the Mozambican population and to promote and provide quality and sustainable health care services, gradually increasing its accessibility to all Mozambicans with equity and efficiency.
The Centro de Investigacao em Saude da Manhica (CISM) is the first peripheral health research centre in Mozambique to undertake medical research into the key health problems in that country. Founded in 1996, CISM was developed under a collaborative programme between the Mozambique Ministry of Health, the Maputo School of Medicine (Universidade Eduardo Mondlane), and the Hospital Clinic of the University of Barcelona (www.hospitalclinic.org) with core funding from the Spanish Agency for International Cooperation. Visit CISM`s web site at www.manhica.org.
Malaria-Impfstoff weckt neue Hoffnung
Mediziner testen den Wirkstoff mit Erfolg an 1600 afrikanischen Kindern - 30 Prozent weniger Erkrankungsfälle
von Sonja Kastilan
Eine Malaria Stechmücke "Anopheles quadrimaculatus"
Foto: dpa
Berlin - Im Jahr 2010 wird die Hälfte der Weltbevölkerung, fast 3,5 Milliarden Menschen, in Malaria-Gebieten leben. Eine parasitäre Tropenkrankheit, an der schon jetzt eine bis drei Millionen Menschen jährlich sterben.
Aber möglicherweise gelingt es bis dahin, einen wirksamen Impfstoff gegen die krankheitserregenden Plasmodien auf den Markt zu bringen. Der Wirkstoff RTS,S/ASO2A, der in Mosambik erfolgreich an 1605 Kindern getestet wurde im Vergleich zu 417 Kindern, die andere Impfstoffe erhielten, könnte dann vielleicht diese Lizenz erhalten, mutmaßen Philippe Van de Perre und Jean-Pierre Dedet von der Universität in Montpellier.
In der aktuellen Ausgabe von "The Lancet" kommentieren die beiden Forscher eine klinische Studie unter Leitung von Professor Pedro L. Alfonso, Universität Barcelona, zu diesem Impfstoffkandidaten. Dessen Verträglichkeit, Sicherheit, Immunogenität und Effizienz seien ermutigend für eine Phase II. Mit den Resultaten sei "eine Schlacht - nicht der Krieg - gegen Malaria gewonnen". In einem Zeitraum von sechs Monaten wurden die Fälle von Malaria-Episoden bei den geimpften Kindern um etwa 30 Prozent gedrosselt, die Zahl der lebensgefährlichen Erkrankungen um 58 Prozent. Das Mittel setzt sich aus einem Oberflächenprotein des Malaria-Erregers und einem bereits erprobten Hepatitis-B-Impfstoff zusammen. 15 Jahre Forschungsarbeit waren dafür nötig.
25 Malaria-Impfstoffkandidaten befinden sich derzeit im Phase-I-Test und 16 in Phase II. Sie alle verfolgen unterschiedliche Strategien. Der jetzt in endemischen Gebieten geprüfte Kandidat RTS,S/ASO2A richtet sich gegen so genannte Sporozoiten - in diesem Entwicklungsstadium befindet sich der Erreger, wenn er beim Mückenstich auf den Menschen übertragen wird, dann die roten Blutzellen infiziert und im Körper weitere Stadien durchläuft. Die Herstellerfirma Glaxo-Smithkline (GSK) hat den Impfstoff ab dem Jahr 2000 zusammen mit der Malaria Vaccine Initiative entwickelt, um vor allem Kinder zu schützen. Studien in Gambia bewiesen bereits seine Sicherheit, jetzt zeigte sich auch die Effizienz.
Im subtropischen Mosambik drohen jedem Bewohner im Jahr rund 38 Stiche von Anopheles-Mücken, die mit dem Malaria-Parasit Plasmodium falciparum infiziert sind. Das Risiko, eine klinische Malaria-Episode zu entwickeln, war um 30 Prozent reduziert, wenn den Kindern der neue Impfstoff gespritzt wurde. Insgesamt erhielten mehr als 2000 Kinder drei Impfinjektionen - entweder den neuen Wirkstoff oder einen anderen Impfstoff etwa gegen Hepatitis B.
"Wir haben einen Meilenstein im Kampf der Menschheit gegen Malaria hinter uns gebracht", sagte GSK-Biologicals-Chef Jean Stephenne. Die Forscher halten es für möglich, den Impfstoff nach erforderlichen weiteren Testphasen ab 2010 für "zehn bis 20 Dollar" je Patient auf den Markt zu bringen. Bislang gibt es gegen Malaria nur Medikamente, die vorsorglich geschluckt werden müssen und zum Teil beträchtliche Nebenwirkungen zeigen.
Quelle : http://www.welt.de/data/2004/10/15/346194.html
Mediziner testen den Wirkstoff mit Erfolg an 1600 afrikanischen Kindern - 30 Prozent weniger Erkrankungsfälle
von Sonja Kastilan
Eine Malaria Stechmücke "Anopheles quadrimaculatus"Foto: dpa
Berlin - Im Jahr 2010 wird die Hälfte der Weltbevölkerung, fast 3,5 Milliarden Menschen, in Malaria-Gebieten leben. Eine parasitäre Tropenkrankheit, an der schon jetzt eine bis drei Millionen Menschen jährlich sterben.
Aber möglicherweise gelingt es bis dahin, einen wirksamen Impfstoff gegen die krankheitserregenden Plasmodien auf den Markt zu bringen. Der Wirkstoff RTS,S/ASO2A, der in Mosambik erfolgreich an 1605 Kindern getestet wurde im Vergleich zu 417 Kindern, die andere Impfstoffe erhielten, könnte dann vielleicht diese Lizenz erhalten, mutmaßen Philippe Van de Perre und Jean-Pierre Dedet von der Universität in Montpellier.
In der aktuellen Ausgabe von "The Lancet" kommentieren die beiden Forscher eine klinische Studie unter Leitung von Professor Pedro L. Alfonso, Universität Barcelona, zu diesem Impfstoffkandidaten. Dessen Verträglichkeit, Sicherheit, Immunogenität und Effizienz seien ermutigend für eine Phase II. Mit den Resultaten sei "eine Schlacht - nicht der Krieg - gegen Malaria gewonnen". In einem Zeitraum von sechs Monaten wurden die Fälle von Malaria-Episoden bei den geimpften Kindern um etwa 30 Prozent gedrosselt, die Zahl der lebensgefährlichen Erkrankungen um 58 Prozent. Das Mittel setzt sich aus einem Oberflächenprotein des Malaria-Erregers und einem bereits erprobten Hepatitis-B-Impfstoff zusammen. 15 Jahre Forschungsarbeit waren dafür nötig.
25 Malaria-Impfstoffkandidaten befinden sich derzeit im Phase-I-Test und 16 in Phase II. Sie alle verfolgen unterschiedliche Strategien. Der jetzt in endemischen Gebieten geprüfte Kandidat RTS,S/ASO2A richtet sich gegen so genannte Sporozoiten - in diesem Entwicklungsstadium befindet sich der Erreger, wenn er beim Mückenstich auf den Menschen übertragen wird, dann die roten Blutzellen infiziert und im Körper weitere Stadien durchläuft. Die Herstellerfirma Glaxo-Smithkline (GSK) hat den Impfstoff ab dem Jahr 2000 zusammen mit der Malaria Vaccine Initiative entwickelt, um vor allem Kinder zu schützen. Studien in Gambia bewiesen bereits seine Sicherheit, jetzt zeigte sich auch die Effizienz.
Im subtropischen Mosambik drohen jedem Bewohner im Jahr rund 38 Stiche von Anopheles-Mücken, die mit dem Malaria-Parasit Plasmodium falciparum infiziert sind. Das Risiko, eine klinische Malaria-Episode zu entwickeln, war um 30 Prozent reduziert, wenn den Kindern der neue Impfstoff gespritzt wurde. Insgesamt erhielten mehr als 2000 Kinder drei Impfinjektionen - entweder den neuen Wirkstoff oder einen anderen Impfstoff etwa gegen Hepatitis B.
"Wir haben einen Meilenstein im Kampf der Menschheit gegen Malaria hinter uns gebracht", sagte GSK-Biologicals-Chef Jean Stephenne. Die Forscher halten es für möglich, den Impfstoff nach erforderlichen weiteren Testphasen ab 2010 für "zehn bis 20 Dollar" je Patient auf den Markt zu bringen. Bislang gibt es gegen Malaria nur Medikamente, die vorsorglich geschluckt werden müssen und zum Teil beträchtliche Nebenwirkungen zeigen.
Quelle : http://www.welt.de/data/2004/10/15/346194.html
na hoffen wir mal, dass das für den Hilftsstoff von CRXA auch etwas bringt, z.B. neue Forschungsaufträge, oder BEsetllungen des MPL®-Adjuvants. Auf jedenfall könnt CRXA mal etwas mehr auftrieb gebrauchen.
Um mal einen user vom Yahoo.com-board zu zitieren:
CRXA to the moon....
Um mal einen user vom Yahoo.com-board zu zitieren:
CRXA to the moon....
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