【drug-news】II期试验结果良好，丙肝疫苗研制取得进展
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Hep C vaccine shows promise
By Kirsty Barnes
21/08/2007 - An experimental peptide-based hepatitis C vaccine has shown promise in interim Phase II trial data, according to its developer Intercell.
The hepatitis C virus (HCV) is a major cause of chronic liver disease and 170m people worldwide carry the disease, however, currently there is no available vaccine.
Intercell's vaccine (IC41) comprises of eight T-cell antigens, combined with its first-generation poly-arginine adjuvant (IC30). It is designed to stimulate T-cell responses against HCV protein structures and reduce viral load.
Intercell said that the first data to be analysed from half of the 50 treatment-naïve study participants showed that its vaccine met the primary endpoint of achieving a statistically significant viral load (HCV-RNA) reduction.
During the study, patients received eight injections of IC41, bi-weekly for 14 weeks. In addition to meeting the primary endpoint, a "very good safety profile" was achieved, the Austrian drug development firm said.
Intercell added that the trial subjects were chronically infected with HCV Genotype 1, which is notoriously difficult to treat with the current gold standard, interferon/ribavirin.
However, the firm said that the data still has to be interpreted with caution given the small sample size. The full study data is expected at the beginning of 2008. An extended analysis of how the therapeutic effect relates to the induction of T-cell responses is also expected at this point.
"The data opens the door for therapeutic vaccination in the arena of existing and future treatment options - but [is] not yet a breakthrough for vaccination as monotherapy."
"The new data obtained encourages us very much to further strengthen our HCV franchise and to accelerate our efforts towards obtaining an HCV therapeutic vaccine", added Gerd Zettlmeissl, CEO of Intercell.
As part of this, Intercell said that in conjunction with its HCV vaccine co-development partner, Novartis, it will define a further development strategy that might also take advantage of an enlarged antigen portfolio and of IC31, its second-generation adjuvant that has "recently demonstrated the generation of T-cell responses, in human vaccine trials, to a level not yet seen for other known adjuvants".
In 2006 worldwide sales of HCV drugs totalled
By Kirsty Barnes
21/08/2007 - An experimental peptide-based hepatitis C vaccine has shown promise in interim Phase II trial data, according to its developer Intercell.
The hepatitis C virus (HCV) is a major cause of chronic liver disease and 170m people worldwide carry the disease, however, currently there is no available vaccine.
Intercell's vaccine (IC41) comprises of eight T-cell antigens, combined with its first-generation poly-arginine adjuvant (IC30). It is designed to stimulate T-cell responses against HCV protein structures and reduce viral load.
Intercell said that the first data to be analysed from half of the 50 treatment-naïve study participants showed that its vaccine met the primary endpoint of achieving a statistically significant viral load (HCV-RNA) reduction.
During the study, patients received eight injections of IC41, bi-weekly for 14 weeks. In addition to meeting the primary endpoint, a "very good safety profile" was achieved, the Austrian drug development firm said.
Intercell added that the trial subjects were chronically infected with HCV Genotype 1, which is notoriously difficult to treat with the current gold standard, interferon/ribavirin.
However, the firm said that the data still has to be interpreted with caution given the small sample size. The full study data is expected at the beginning of 2008. An extended analysis of how the therapeutic effect relates to the induction of T-cell responses is also expected at this point.
"The data opens the door for therapeutic vaccination in the arena of existing and future treatment options - but [is] not yet a breakthrough for vaccination as monotherapy."
"The new data obtained encourages us very much to further strengthen our HCV franchise and to accelerate our efforts towards obtaining an HCV therapeutic vaccine", added Gerd Zettlmeissl, CEO of Intercell.
As part of this, Intercell said that in conjunction with its HCV vaccine co-development partner, Novartis, it will define a further development strategy that might also take advantage of an enlarged antigen portfolio and of IC31, its second-generation adjuvant that has "recently demonstrated the generation of T-cell responses, in human vaccine trials, to a level not yet seen for other known adjuvants".
In 2006 worldwide sales of HCV drugs totalled
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