Tripep receives approval to extend ChronVac-C study

Dec 3 2009

Today Tripep (STO:TPEP) received the approval from the Swedish Medical Products Agency and the local ethical committee to give three patients in the highest dose group in the ChronVac-C® study one additional treatment with the therapeutic vaccine.

All twelve patients in the study have earlier received four treatments with ChronVac-C® given at three different doses and one month apart. The highest dose was given to six patients. Three patients in the high dose group will now be offered to receive a fifth therapeutic vaccination with ChronVac-C® 6 to 12 months after the last vaccination before receiving standard of therapy with interferon and ribavirin. The purpose is to determine if there are beneficial effects from additional so called booster-doses. The three patients will be followed for one month after the fifth therapeutic vaccination where after they also receive standard of therapy.

Tripep has earlier reported on the positive outcome with the activation of an immune response against hepatitis C virus as well as a reduction of the levels of virus in the blood in the phase I/II study where patients are treated with the therapeutic vaccine ChronVac-C®. The study has now been extended with an additional booster-dose for three patients in the highest dose group to test if an extra dose given after a resting period has beneficial effects. Tripep has also reported that the three patients who already after the vaccinations have received standard of care seemed to respond with an unusually rapid elimination of the virus from the blood. All patients, including the three who will receive an extra vaccination will be followed closely when on standard of therapy to find out if pretreatment with ChronVac-C® may give a better and faster treatment result when on standard of care.

”We are very happy that the ChronVac-C® treatment can be extended without further preclinical studies which will speed up the clinical development. It is with great excitement that we look forward to receiving the results from this extra so called booster-injection with ChronVac-C®. In parallel we follow with excitement also the patients from the ChronVac-C® study who now receive standard of therapy with interferon and ribavirin”, says Tripep’s CEO and Head of Research Anders Vahlne.