VIENNA, April 1, 2011 /PRNewswire/ -- Today Intercell AG (VSE: ICLL) announced that it has agreed with Novartis to advance Intercell's investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated ICU (Intensive Care Unit) patients. The planned double blind study is powered to show a clinically meaningful and statistically significant reduction in overall mortality between the vaccine and control group and envisages enrolling about 800 subjects. The study is subject to final regulatory concurrence and its start is planned for first half of 2012. Intercell will execute the trial and the costs will be shared with Novartis.
Intercell's Pseudomonas aeruginosa vaccine program is one of the development programs under the strategic alliance between Intercell and Novartis. Next steps for the program will be decided based upon data from the planned efficacy trial, taking into consideration the Novartis option rights and the Intercell right to choose either profit-sharing or to receive milestones and royalties.
"Pseudomonas infections are a major cause of mortality in artificially ventilated ICU patients. Our Phase II data showed a statistically significant improved survival of patients vaccinated and we are happy that we will together with Novartis move the program forward. This further strongly underlines our leading position to develop vaccines against hospital acquired infections, one of the major medical problems in global societies," states Gerd Zettlmeissl, Chief Executive Officer of Intercell.
The trial is expected to be conducted in various countries, predominantly in the EU, involving up to 50 study sites. Two study groups, both receiving standard of care in addition to vaccine or placebo, will be compared. The subjects in the vaccine group which will comprise about 400 ventilated ICU patients will be vaccinated twice within a 7-day interval with the non-adjuvanted product formulation that was found to most impact observed survival. Primary endpoint of the trial will be mortality at day 28 after first vaccination in both study groups. Secondary objectives are to investigate Pseudomonas aeruginosa infections, infection-related mortality as well as immune response to the vaccine candidate and its safety and tolerability.