EANS-News: Intercell announces initial results of Phase II clinical trial evaluating V710, an investigational Staphylococcus aureus vaccine, in patients with end-stage renal disease

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» Primary Immunogenicity and Safety objectives met
» All
formulations of V710 were immunogenic following a single or two-dose

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Research & Development

Subtitle: - » Primary Immunogenicity and Safety objectives met » All
formulations of V710 were immunogenic following a single or two-dose
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Vienna (Austria), November 18, 2010 (euro adhoc) - Intercell AG (VSE:
ICLL) today announced top-line results from a Phase II clinical trial
of V710, an investigational vaccine for the prevention of
Staphylococcus aureus (S. aureus) infections. The study, conducted by
Intercell's collaborator, a subsidiary of Merck & Co., Inc, (known
outside the U.S. and Canada as MSD) ("Merck") was designed to
evaluate the safety and immunogenicity of V710 in patients with
end-stage renal disease (ESRD) undergoing hemodialysis treatment.

In the randomized double blind, placebo controlled study 201 patients
received vaccine or placebo at 12 centers in the U.S. The study was
designed to assess whether administration of V710 to ESRD patients
receiving hemodialysis at high risk of developing serious S. aureus
infections could increase the level of antibodies to the V710
antigen. The primary endpoints of the study were the change of
antibody levels compared to baseline at 28 days after a 2-dose
regimen provided 28 days apart and all adverse experiences for 14
days after each vaccination. Overall the immunogenicity data suggest
that V710 can elicit a sustained immune response in a relatively
immunocompromised patient population who are at chronic risk for
developing serious S. aureus infections.

Overall, the results of the safety evaluations demonstrated that V710
was generally well tolerated when administered as a single- or
multiple-dose regimen at any dosage group studied. There were no
vaccine-related serious adverse experiences reported throughout the
study duration (Days 1 to 360), and no patients discontinued the
study or subsequent vaccinations due to a vaccine-related adverse
experience.

Merck plans to present the data at an upcoming medical meeting.

"It is very encouraging to see that the S. aureus vaccine has proven
immunogenic and was generally well tolerated in ESRD patients
receiving hemodialysis. We are looking forward to the continued
progress of the S. aureus program at our strategic partner Merck",
commented Gerd Zettlmeissl, CEO of Intercell.

The S. aureus vaccine candidate is based on a conserved protein
antigen discovered by Intercell and licensed to Merck 2004 on an
exclusive world wide basis. Merck is responsible for clinical
development, manufacturing and marketing. Intercell is eligible to
receive milestone payments and royalties on future net sales. In
previous studies the S. aureus candidate vaccine was shown to be
immunogenic and generally well tolerated.

end of announcement euro adhoc
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ots Originaltext: Intercell AG
Im Internet recherchierbar: http://www.presseportal.de

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