Wednesday 6 August 2008

Long Acting Neuraminidase Inhibitor (LANI) Phase II Completed - Phase III Scheduled -Naturally Acquired Influenza A Or B

� Biota Holdings Limited (ASX:BTA)(PINK:BTAHY) proclaimed that its second generation, influenza treatment, CS-8958, has successfully completed its initial Phase II clinical rating, showing favorable outcomes against all metric endpoints. The initial Phase III visitation is scheduled to start later this year. CS-8958 is a long performing neuraminidase inhibitor (LANI), and is co-owned with Daiichi-Sankyo Company Limited (TYO:4758)(PINK:DSKYF).




The Phase II clinical tryout was intentional to test the safety and efficacy of CS-8958 in several hundred adult patients world Health Organization had confirmed, naturally acquired influenza A or B using fever and symptom resolution endpoints after a single inhaled dose. The study was conducted in accordance with guidance from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). In the double-blinded trial, inhaled CS-8958 administered once only was statistically indisting! uishable from 75mg of oseltamivir administered twice daily for! 5 conse cutive days. In earlier presymptomatic tests, CS-8958 has likewise shown