The ChronVac-C® study has been successfully completed with good safety and favorable clinical data

The ChronVac-C® study has been successfully completed with good safety and
favorable clinical data

All samples from the 12 patients with chronic Hepatitis C genotype 1 treated
with Tripep's therapeutic vaccine ChronVac-C® have now been collected. The
treatment was found to be safe, immunogenic and had transient effects on the
serum levels of hepatitis C virus. This provides a proof-of-concept for the
therapeutic strategy. In addition, early data from three patients who have
initiated standard of care treatment after completing the clinical trial have
experienced a rapid loss of the virus, implying a possible role for ChronVac-C®
in combination therapies. Tripep will therefore pursue clinical development of
ChronVac-C® along two lines, the current ChronVac-C® as an addition to standard
of care, and a 2nd generation improved ChronVac-C® as a monotherapy. GMP
production and preclinical safety testing of the 2nd generation ChronVac-C®
should start in the spring of 2010. Finally, Tripep has filed an application
with the Swedish Medical Products Agency to give the last three patients in the
finalized study a fifth booster dose 6-12 months after the fourth dose.

All patients have now completed treatment with ChronVac-C®. A first summary of
available data (immunological analysis of some samples are still under way)
shows that the treatment was found to be safe, immunogenic and had transient
effects on the serum levels of hepatitis C virus. In the lowest (167 µg) dose
group, no reductions in serum levels of HCV RNA were noted and no immune
responses lasting ≥ 1 month were detected. In the 500 µg dose group 2/3 patients
showed transient reductions in serum levels of HCV RNA (up to -1,5log10) and in
the same two patients T cell responses to the vaccine lasting ≥ 1 month were
activated. In the 1500 µg dose group 3/6 patients showed transient reductions in
serum levels of HCV RNA (up to -2,4log10) and in two of these three patients T
cell responses to the vaccine were obtained that lasted ≥ 1 month. This provides
a proof-of-concept for the therapeutic strategy and supports further clinical
development. In addition, early data from three patients who now have initiated
standard of care treatment after completing the clinical trial have experienced
a rapid loss of the virus, possibly suggesting a role for ChronVac-C® in
combination therapies. This data will be monitored for as many patients as
possible during the coming year to obtain a more solid data base. Tripep will
therefore pursue clinical development of ChronVac-C® along two lines, the
current ChronVac-C® as in as an addition to standard of care and an improved 2nd
generation ChronVac-C® as a monotherapy. Preclinical safety testing of 2nd
generation ChronVac-C® should start in the spring of 2010. Finally, Tripep has
filed an application with the Swedish Medical Products Agency to give the last
three patients a fifth booster dose.

“We are extremely pleased with the outcome of the clinical trial in particular
considering that this was the first time ever that a DNA vaccine was delivered
using in vivo electroporation against an infectious disease. We now have an
excellent basis from which we continue clinical development and are looking
forward from the additional exciting clinical data from the patients when they
undergo standard of care therapy. We will report these data as they become
available to us. Following this success we will now actively expand our
therapeutic vaccine program also into chronic hepatitis B were we during 2009
have generated highly promising therapeutic vaccine candidates” says Tripeps CEO
Anders Vahlne.


For more information, please contact:

Anders Vahlne, CEO and Head of Research, Tripep AB
Tel: +46 8 5858 1313, mobile phone: +46 709 28 05 28, 
E-mail: anders.vahlne@ki.se

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. The Tripep share is admitted to trade on First North. Remium AB is
Certified Adviser for Tripep AB.  For more information, please refer to the
company's Website: www.tripep.se.

In the event of any discrepancy between the Swedish and English versions of this
press release, the Swedish version will take precedence.