Apr 28 2010
The multi-center study in Sweden and Norway with ChronSeal® is now finalized and the data are being analyzed in Sweden and by Kringle in Japan. ChronTech and Kringle have jointly decided that the results will be publicly available on May 27th. At follow-up of the ChronVac-C® -study where patients now have started treatment according to standard-of-care (interferon and ribavirin) all patients (100%) were virus free at treatment week 12 and 5/6 (83%) had less than 50 copies of virus/mL blood already at treatment week four. This type of rapid treatment response is very unusual for patients infected with the hard to treat form of HCV called genotype 1 and further underscores a role for ChronVac-C® in a combination therapy.
The ChronVac-C®-study on patients chronically infected with hepatitis C virus (HCV) of genotype 1 is, as has been previously reported, finalized and shows that the therapeutic vaccine has good safety and shows positive clinical data. Two patients in the ChronVac-C®-study have received an additional dose approximately 6-12 months after the fourth vaccination and analysis of the results are under way. Now six patients in the study have started treatment with standard of care-therapy, i.e. interferon combined with ribavirin. Five of these (83%) have responded quickly on the treatment with <50 virus copies/mL blood already after four weeks (so called rapid viral response) in comparison to normally only 10-15% rapid viral response after standard treatment only. This unusually rapid reduction of virus in the blood indicates that there is a role for ChronVac-C® in combination therapy. All six patients are now virus free and the two patients who have already been treated for 24 weeks could at that time stop therapy and are today considered cured. Also this good treatment outcome is unusual for patients infected with HCV of genotype 1 where the normal treatment time is 48 weeks and 40-50% of the patients are virus free after completing their treatment.
"We are very happy over the results we have obtained in the ChronVac-C® study and look forward with confidence to the results from the ChronSeal® study. An intensive work is now ongoing with the continued clinical development. We look forward with excitement to begin clinical studies that will take us closer to final medicines" says Anders Vahlne, CEO of ChronTech Pharma.