Intercell AG

EANS-Adhoc: Intercell AG
Intercell announces Phase I results on its Vaccine Enhancement Patch (VEP) with Pandemic Influenza antigens

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Research & Development

18.09.2012

<< The co-administration of  an A/H5N1 antigen via intramuscular administration
(IM) with VEP met two of three CHMP criteria for Pandemic Influenza Vaccines,
but the intended level of increased immune response  was not achieved 

<< Intercell will focus its future patch strategy on partnering and
out-licensing based on an updated target product profile

Vienna (Austria), September 18, 2012 - Today Intercell AG (VSE: ICLL) announced
the results from a Phase I study investigating Intercell's adjuvant patch
(Vaccine Enhancement Patch - VEP) containing LT (a heat-labile toxin from E.
coli) in combination with an IM administration of an A/H5N1 antigen supplied by
GSK. 

This trial follows earlier Phase I and Phase II clinical investigations in
combination with a pandemic Influenza antigen (manufactured by Solvay
Biologicals, B.V.) carried out by Iomai Corp./ Intercell USA Inc. under a
contract with the U.S. Department of Health and Human Services (HHS) to develop
a dose-sparing Pandemic Influenza approach with the potential for a single
application immunization.

The recent trial was performed to confirm the mode of action of transcutaneous
applied adjuvants when co-administered with an Influenza A/H5N1 antigen,
following different and inconsistent results from the previous Phase I and Phase
II clinical studies.

The study involved 300 healthy adults and investigated two combinations of
A/H5N1antigen doses with or without patch in one and two injection regimes.
GSK's adjuvanted and licensed H5N1 vaccine was used to provide a positive
control arm.

The combination of A/H5N1 with VEP met two of three CHMP criteria for Pandemic
Influenza Vaccines (GMT fold rise from day 0 and Seroconversion). However, the
study endpoint of a 2 or more fold rise in HI titers was not achieved since the
immunogenicity was only moderately increased by VEP.

Further analysis revealed that the VEP effect was more pronounced and
statistically significant on titer, seroconversion and seroprotection in
subjects with existing HI titer (of > 1:10 at day 21) compared to A/H5N1 alone
which indicates the potential for use of the VEP for booster vaccinations.

The overall adverse event rate was similar across all treatment groups and the
local safety profile for the VEP was as expected from previous observations in
various clinical studies where LT was administered transcutaneously. 

"We are glad that we have been able to achieve a valid and decisive study
outcome that allows us to finally assess the potential of the Vaccines Enhance
Patch - our remaining Patch based program under clinical investigation. Although
the external adjuvantation effect in combination with A/H5N1 is not sufficient
to proceed in a priming Pandemic Influenza indication, the results do indicate
opportunities for transcutaneous booster vaccinations", states Thomas
Lingelbach, Chief Executive Officer of Intercell AG.

Based on this study outcome and other pre-clinical results achieved with
different antigens, Intercell will focus its future patch strategy on partnering
and out-licensing - with a strong emphasis on antigen delivery as well as
booster vaccination target product profiles.


Further inquiry note:
Intercell AG
Nina Waibel
Corporate Communications
Tel. +43 1 20620-1222
communications@intercell.com

end of announcement                               euro adhoc 
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issuer:      Intercell AG
             Campus Vienna Biocenter  3
             A-1030 Wien 
phone:       +43 1 20620-0
FAX:         +43 1 20620-800
mail:     investors@intercell.com 
WWW:      www.intercell.com
sector:      Biotechnology
ISIN:        AT0000612601
indexes:     ATX Prime
stockmarkets: official market: Wien 
language:   English
 



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