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Intercell Starts a Phase I Clinical Trial for a New Streptococcus pneumoniae Vaccine

Posted on: Tuesday, 7 April 2009, 12:53 CDT

- Initiation of a first-in-man Phase I clinical trial in healthy subjects

- Study aims to obtain safety and immunogenicity data of this new vaccine candidate

- Initial results expected in Q4 2009

- Development of Intercell's Streptococcus pneumoniae vaccine supported by PATH

VIENNA, April 7 /PRNewswire/ -- Intercell AG (VSE: ICLL) announced today that a Phase I clinical trial with the company's vaccine candidate IC47 to prevent disease caused by the bacterium Streptococcus pneumoniae has started.

Intercell's vaccine candidate is a recombinant subunit vaccine consisting of three conserved surface proteins from Streptococcus pneumoniae. Two of these proteins were discovered using Intercell's proprietary Antigen Identification Program (AIP(R)), while the third was in-licensed from the U.S. Centers of Disease Control and Prevention (CDC).

This Phase I trial is a first-in-man study with a focus to obtain safety and immunogenicity data in a small population of healthy adults. Thirty-two subjects will be enrolled in this open-label study. Two different vaccine concentrations either with or without the addition of an adjuvant will be tested.

"The initiation of this clinical Phase I trial is an important step to further strengthen Intercell's leading position in the development of vaccines against infectious diseases with significant unmet medical need," commented Intercell's Chief Scientific Officer, Alexander von Gabain.

Although vaccines against Streptococcus pneumoniae are available, they cover only a restricted number of the more than 90 known serotypes and it is essential to pursue new vaccines for distribution in countries with the highest medical need for an effective vaccine against the pathogen. Intercell's novel vaccine candidate is composed of highly conserved proteins of Streptococcus pneumoniae that have the potential to protect against all serotypes.

The development of Intercell's vaccine to prevent pneumococcal disease is supported by PATH - a U.S.-based non-profit organization that creates sustainable, culturally relevant solutions that enable communities worldwide to break longstanding cycles of poor health. Having supported the preclinical studies of the IC47 vaccine, PATH has now committed another USD 3.6 m for the further clinical development until Q2 2010, including the Phase I trial. Under the terms of the collaboration, Intercell will develop the vaccine and make it available at an affordable cost for children in developing world countries at greatest need, where Pneumococcus is a major cause of infant and childhood mortality.

About Streptococcus pneumoniae (Pneumococcus)

Streptococcus pneumoniae, or Pneumococcus, is a very common bacterial infection in both industrialized and developing countries. In particular, young children and the elderly represent high-risk populations of developing pneumococcal infections. According to the WHO, the bacterium kills up to one million children under the age of five years each year worldwide. It accounts for many Bacterial Meningitis cases in adults and it is the most common cause of Bacteraemia, Pneumonia, Meningitis and Otitis media in young children.

About Intercell AG

Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the Company's first product on the market.

The Company's technology platforms include an antigen-discovery system, adjuvants and a novel patch-based delivery system. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, and Sanofi Pasteur.

The Company's pipeline includes a Travelers' Diarrhea Vaccine Patch (Phase II), a Pseudomonas vaccine candidate (Phase II), a Vaccine Enhancement Patch with infected Pandemic Influenza vaccines (one shot plus patch, Phase I), a Phase II vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). In addition, three other products focused on infectious diseases are in pre-clinical development.

Intercell is listed on the Vienna stock exchange under the symbol "ICLL".

For more information, please visit: www.intercell.com

This communication expressly or implicitly contains certain forward-looking statements concerning Intercell AG and its business. 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.

SOURCE Intercell AG

Source: PR Newswire

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