Intercell starts the second part of a Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections

Intercell starts the second part of a Phase I clinical trial with vaccine candidate to prevent Clostridium difficile infections

  • Trial in vaccine target group of elderly subjects (elderly >65 years) initiated
  • First data from Phase I clinical trial showed good safety and immunogenicity of the vaccine candidate against Clostridium difficile, the major cause of nosocomial diarrhea, in healthy young adults
  • Study aims to obtain safety and immunogenicity data in elderly subjects with results expected in Q2 2013

Vienna (Austria), March 1, 2012 – Intercell AG (VSE: ICLL) today announced the start of the second half of a Phase I clinical trial with the company's vaccine candidate IC84 to prevent disease caused by the bacterium Clostridium difficile (C. difficile).

First data from the Phase I study (Phase Ia) in a population of healthy adults aged 18-65 years showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies in this study population. This supported the decision to carry forward the vaccine candidate for safety and dose-confirmation in the elderly.

The second part of the Phase I study (Phase Ib) will enroll 80 healthy elderly subjects above 65 years of age, as this age group represents the main target population for a C. difficile vaccine. Two vaccine concentrations will be tested with and without alum to confirm the vaccine dose and necessity of the adjuvant in the elderly. Compared to the Phase Ia part of the study in healthy young adults, the vaccination schedule has been modified to potentially optimize the immune response in elderly subjects who might respond differently to the vaccination due to their immunosenescence.

Intercell's vaccine candidate is a recombinant fusion protein 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.

The pathogen C. difficile is one of the main causes of nosocomial diarrhea.

About Clostridium difficile infection

C. difficile is an anaerobic spore-forming bacterium that causes diarrhea and more serious intestinal conditions such as colitis. C. difficile is shed in faeces and any surface, device, or material that becomes contaminated with faeces may serve as a reservoir for the C. difficile spores. When the natural microbial flora of the gut is disturbed (e.g. as a result of antibiotic treatment) and a patient gets in contact with C. difficile spores - this can result in a broad range of gastrointestinal symptoms. The symptoms may include diarrhea, cramping, dehydration, fever, nausea and vomiting. In advanced stages it can cause bloody diarrhea and severe inflammation of the gut. C. difficile spores are transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item.

C. difficile rarely causes infections in healthy persons but is a significant threat for patients with gastrointestinal surgery, or for subjects in healthcare settings or with immunocompromising conditions.

Currently, no vaccine against C. difficile exists, and antibiotic treatment of the established disease has significant limitations. The incidence of nosocomial infections is steadily increasing due to the growing number of medical interventions and antibiotic resistance. Intercell aims at developing a vaccine for the prevention of recurring C. difficile Diarrhea, for hospital prophylaxis, and eventually for community-wide prophylaxis on an age- and risk-based vaccination strategy.

About Intercell AG

Intercell AG is a vaccine-biotechnology company with the clear vision to develop and commercialize novel immunomodulatory biologicals to prevent disease and reduce suffering across the world.
Intercell's vaccine to prevent Japanese Encephalitis (JE) is the Company's first product on the market. This is a next generation vaccine against the most common vaccine-preventable cause of encephalitis in Asia licensed in more than thirty countries.

The Company's technology base includes novel platforms, such as the patch-based delivery system and the proprietary human monoclonal antibody discovery system eMAB®, in addition to well-established technologies upon which Intercell has entered into strategic partnerships with a number of leading pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., and Sanofi.

The Company's pipeline of investigational products includes a development program for the pediatric use of Intercell's JE-Vaccine IXIARO® in non-endemic markets and the development for endemic markets in collaboration with Biological E. of a comparable vaccine based on Intercell's technology. Furthermore, the portfolio comprises different product candidates in clinical trials: a Pseudomonas aeruginosa vaccine candidate (Phase II/III) partnered with Novartis, a vaccine to prevent Pandemic Influenza by combining the Company's Vaccine Enhancement Patch with an injected vaccine (Phase I, a vaccine candidate against infections with C. difficile (Phase I) as well as numerous investigative vaccine programs using the Company's IC31® adjuvant, e.g. in a Tuberculosis vaccine candidate (Phase II).
Intercell is listed on the Vienna Stock Exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").
For more information, please visit: www.intercell.com

Contact
Intercell AG
Nina Waibel
Corporate Communications
Campus Vienna Biocenter 3, A-1030 Vienna
P: +43-1-20620-1222/-1116
Mail to: [email protected]

This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," or similar words. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Intercell AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Intercell AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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