EANS-Adhoc: Intercell reports Phase II Study Results of its Vaccine Enhancement Patch for Pandemic Influenza Intercell intends to proceed with clinical studies
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Research & Development
02.07.2010
Vienna (Austria)/Gaithersburg (USA), July 2, 2010 - Intercell AG (VSE: ICLL) today announced the results of a Phase II clinical trial of its investigational Vaccine Enhancement Patch (VEP) system for avian H5N1 influenza. In this development program, Intercell is working under a contract with the U.S. Department of Health and Human Services (HHS) to develop a dose-sparing approach with potential for a single dose immunization against pandemic influenza that combines a H5N1 vaccine with Intercell´s LT adjuvant patch.
Following encouraging pre-clinical and clinical Phase I proof-of-concept trials conducted under this HHS contract, the clinical Phase II study was designed to determine the safety and the optimal combination/dose of an injectable H5N1 influenza vaccine (30 and 45µg antigen) and Intercell´s VEP (50 and 100µg LT adjuvant) applied at the injection site. A total of 500 healthy adults were recruited in 6 study groups.
The study did not identify the optimal combination of antigen and adjuvant because no statistically significant difference in seroprotection rates as measured by Haemagglutinin Inhibition (HI) assay was observed when comparing groups with and without VEP.
However, the study results demonstrated a good safety profile for all doses of injectable vaccine and adjuvant patches studied. Furthermore, a dose-dependent response to the H5N1 antigen was observed. Anti-LT IgG titers in study subjects receiving the patch confirmed that Intercell´s VEP could consistently deliver the vaccine adjuvant.
Intercell intends to conduct further clinical evaluation using its VEP in combination with an injectable H5N1 vaccine to be supplied by GlaxoSmithKline (GSK) as part of a collaborative agreement signed in December 2009. HHS and Intercell are currently considering the next steps for this development program.
"Single-dose protection against highly pathogenic pandemic influenza strains such as H5N1 is an important goal for pandemic protection, but one which has been shown to be challenging ", said Thomas Lingelbach, Chief Operating Officer of Intercell and CEO & President Intercell USA Inc. "We think that despite the inconclusive results, our Vaccine Enhancement Patch is uniquely positioned to have the potential to achieve single-dose protection and hence Intercell using its partner GSK´s vaccine intend to proceed with further clinical evaluation."
end of announcement euro adhoc
Further inquiry note:
Intercell AG
Lucia Malfent
Vice President, Global Head Corporate Communications
Tel. +43 1 20620-1303
lmalfent@intercell.com
Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Index: ATX Prime, ATX
Börsen: Wien / official market