EANS-News: Intercell AG
Intercell announces first data from its Phase I
clinical trial with vaccine candidate to prevent Clostridium difficile infections
24.10.2011 – 08:09
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- Research & Development Wien (euro adhoc) - Intercell announces first data from its Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections » Intercell is progressing its vaccine candidate against Clostridium difficile, the major cause of nosocomial diarrhea, into the target population of elderly subjects based on initial data from its Phase I study » Data show good safety and immunogenicity of the vaccine candidate and indicate functionality of the induced antibodies » Second part of the study in the target population of elderly subjects will be initiated Vienna (Austria), October 24, 2011 - Intercell AG (VSE: ICLL) today announced first data from a Phase I clinical trial with the company's vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile). The pathogen is one of the main causes of nosocomial diarrhea. Intercell's vaccine candidate is a recombinant protein vaccine consisting of two truncated toxins A and B from C. difficile. The toxins are known to be disease-causing and anti-toxin immunity can be protective. This Phase I trial is a first-in-man study to obtain safety and immunogenicity data. The first part of the study is in a population of healthy adults up to 65 years. The second part is in healthy elderly subjects above 65 years of age as this age group is considered to represent the main target population for a C. difficile vaccine. The first part of the study has enrolled 60 healthy adults (18-65 years). Three different alum-adjuvanted vaccine candidate concentrations were tested in a 3 times-vaccination schedule; two of the three vaccine concentrations were additionally tested without adjuvant. An independent Data Safety Monitoring Board (DSMB) reviewed safety as primary objective of the study and did not identify any safety concern in any of the IC84 treatment arms. IC84 induced antibodies reacted with both native toxins A and B of C. difficile. A dose response to the vaccine candidate could be observed; the non-adjuvanted candidates were at least as immunogenic as the adjuvanted for both toxins, respectively. Functionality of IC84-induced antibodies could be shown in toxin-neutralizing assays. Based on the data form the first part of the study, the two higher doses will be carried forward to the second part of the study for dose-confirmation in elderly. Also, the necessity of the adjuvant will need to be confirmed in the elderly, who might respond differently to vaccination than the younger subjects due to immunosenescence. Modification of the vaccination schedule will be implemented to potentially further optimize the immune response in elderly. Further inquiry note: Intercell AG Nina Waibel Corporate Communications Tel. +43 1 20620-1222 communications@intercell.com end of announcement euro adhoc -------------------------------------------------------------------------------- company: 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