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Tripep
Receives Approval for Expanding the
ChronVac-C Study with One More Vaccination
Stockholm
-- December 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.
Tripep
develops drugs against chronic disease based
on proprietary and other parties' patented and
patent pending technologies. Tripep is focusing
on the following research projects; wound healing
therapy ChronSeal and a therapeutic vaccine
against Hepatitis C, named ChronVac-C, plus
the RAS technology platform.
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