Intercell AG

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Statens Serum Institut (SSI), Intercell (ICLL), and Aeras Global Tuberculosis Vaccine Foundation (Aeras) announce the initiation of a clinical trial for a novel vaccine candidate against tuberculosis (TB)

-------------------------------------------------------------------------------- Disclosure announcement transmitted by euro adhoc. The issuer is responsible for the content of this announcement. -------------------------------------------------------------------------------- Research & Development 04.12.2007 » SSI´s novel tuberculosis subunit vaccine HyVac4-IC31 (AERAS-404) enters phase I clinical trial in BCG-vaccinated individuals » The vaccine is a new candidate from a group of subunit vaccines against TB produced by SSI and aiming to boost the activity of the existing BCG vaccine » HyVac4-IC31 (AERAS-404) is co-developed with Aeras and formulated with Intercell´s adjuvant IC31® December 4th, 2007 (Copenhagen, Denmark / Vienna, Austria / Rockville, MD, USA) - SSI, ICLL, and Aeras announce that SSI´s novel prophylactic vaccine HyVac4-IC31 (AERAS-404) against TB have entered phase I clinical trials in BCG-vaccinated individuals. The clinical trial has been initiated at the Karolinska Institute (Stockholm). The new TB-vaccine HyVac4-IC31 (AERAS-404) supported by and co-developed with AERAS is based on the H4-antigen which in the preclinical phase has shown remarkable activity as a BCG booster. "With the initiation of this clinical trial on the TB vaccine molecule HyVac4 we are intensifying our efforts to provide the best possible TB vaccine to control the global TB epidemic" says Professor Peter Andersen, Vice President for Vaccine R&D at the SSI. "Our proprietary adjuvant IC31® has proven to be safe and to induce a strong and sustained immune response that has not yet been seen before in comparable preclinical and clinical vaccine settings. We are confident that this further vaccine candidate will fulfil the expectations in the clinical development to target this high unmet medical need", comments Intercell´s Chief Scientific Officer Alexander von Gabain. "We are pleased to be working in partnership with SSI and ICLL on this very promising TB vaccine candidate," says Dr. Jerald C. Sadoff, President and CEO of Aeras. "HyVac4 (AERAS-404) has induced more significant protection in a BCG prime-boost regimen than any other vaccine we have tested in the long-term guinea pig challenge model." About Tuberculosis (TB): TB causes the death of more than 1.5 million people every year and one-third of the world´s population is infected by the bacteria "Mycobacterium tuberculosis" which makes this disease one of the most severe global health problems.The existing Bacillus Calmette-Guérin vaccine (BCG) vaccine is a live vaccine that, when given to newborns, provides good protection against TB for 10-15 years. However, when the protective effect decreases, yet another BCG vaccination does not provide sufficient TB protection. Therefore, a new type of TB vaccine is needed to address the need of TB protection in the adult population. About HyVac4: HyVac4 is a recombinantly engineered TB vaccine antigen in which immunodominant antigens (Ag85B and TB10.4) secreted by Mycobacterium Tuberculosis are combined to provide highly efficient and immunogenic fusion molecules. HyVac4 is closely related to the Hybrid1 (H1) TB vaccine antigen which earlier this year successfully completed a phase I clinical trial in Leiden also in combination with IC31® and for which further clinical trials are in preparation. About IC31®: Adjuvants enhance the effectiveness of vaccines. Existing adjuvants on the market induce antibodies but no or little T-cell immunity. IC31® is an adjuvant inducing both T-cell and B-cell responses with a unique synthetic formulation which combines the immunostimulating properties of an anti-microbial peptide, KLK, and an immunostimulatory oligodeoxynucleotide, ODN1a. The two-component solution can be simply mixed with antigens, no conjugation is required. Intercell currently has IC31® collaborations with a number of global vaccine companies, as well as small biotechs. IC31® has also been partnered with Novartis and Wyeth for the development of a couple of new vaccines against infectious diseases. About Statens Serum Institut (SSI): SSI is a public enterprise operating as a market-oriented production and service enterprise. SSI is an enterprise under the Danish Ministry of Health and Prevention, and the Institute´s duties are partly integrated in the national Danish health services. SSI prevents and controls infectious diseases, biological threats, and congenital disorders. About AERAS Global TB Vaccine Foundation: Aeras Global TB Vaccine Foundation (www.aeras.org) is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are affordable and accessible to all who need them around the world. end of announcement euro adhoc 04.12.2007 08:25:05 -------------------------------------------------------------------------------- ots Originaltext: Intercell AG Im Internet recherchierbar: http://www.presseportal.ch Further inquiry note: Intercell AG Lucia Malfent Head of Communications Tel. +43 1 20620-303 lmalfent@intercell.com Branche: Biotechnology ISIN: AT0000612601 WKN: A0D8HW Börsen: Wiener Börse AG / official market

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