Preliminary results from the first Phase lll-study of the ETEC-vaccine

Preliminary results from the first Phase lll-study of the ETEC-vaccine There are two phase III studies for the candidate ETEC vaccine against travellers diarrhoea both coordinated by Johns Hopkins School of Hygiene and Public Health in Baltimore, USA. These are in Guatemala and in Mexico. The first study, with Professor David Sack as principal investigator, comprising 671 travellers has recently been completed. Data analyses show that the primary clinical endpoint as defined was not met i.e. protection against travellers' diarrhoea caused by vaccine preventable ETEC infection. However, further preliminary analyses indicate a trend for protection against moderate to severe diarrhoea as opposed to mild cases. As a consequence an application for registration in Europe can not be submitted this year as planned. More analyses are ongoing including laboratory parameters. The data from the first study will give us valuable information for the further development of the clinical program. The second study started in November 1999 in collaboration with SmithKline Beecham Biologicals, licensee for the worldwide rights outside the Nordic countries. Recruitment should be completed this summer. So far the study has included more than 200 travellers and the work is progressing well. This study is conducted with vaccine produced in accordance with the commercial product specification. Lund 29 March 2000 Active Biotech AB (publ) Sven Andréasson President & CEO Active Biotech AB is a Swedish biotechnology group focused on the research and development of pharmaceuticals and vaccines; our core competence being our knowledge of the human immune system. We have a high quality project portfolio and considerable financial resources. Important products include our Dukoral, SBL Cholera Vaccine, a vaccine against tourist diarrhoea (ETEC), innovative drugs against MS (SAIK) and cancer (TTS). The turnover of Active Biotech was SEK 267 million in 1999. Active Biotech AB Box 724, S-220 07 Lund, Sweden Tel +46 46-19 20 00 Fax +46 46 19 20 50 E-mail info@activebiotech.com ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/2000/03/29/20000329BIT00150/bit0001.doc http://www.bit.se/bitonline/2000/03/29/20000329BIT00150/bit0002.pdf