http://www.intercell.com/main/forbeg…stigational-s/

November 18, 2010

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

•Primary Immunogenicity and Safety objectives met

•All formulations of V710 were immunogenic following a single or two dose application

Vienna (Austria), November 18, 2010 – 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.

http://www.intercell.com/main/forvac…ureus-vaccine/

The first critical interim analysis (surpassing futility) are expected for 2011.

I love that the pharmas get to “threaten” not to market their own products, in order to scare te CDC into toeing the line.