Phase III Results With Biogen's Interferon Beta

Product development in the area of multiple sclerosis continues apace with pivotal trial results becoming available for a number of new agents (see also page 19). Among these, Biogen has announced Phase III results of its recombinant interferon beta candidate which suggest that it can confer a 75% increase in predicted time to disability and one-third reduction in exacerbation in active relapsing MS patients.

The results of the 301-patient study were presented on October 10 at the combined American and UK Neurological Association's annual meeting in San Francisco, USA, by chief investigator Lawrence Jacobs, head of neurology at Buffalo General Hospital, New York.

At the end of one year of treatment with either 30ug interferon by intramuscular injection once per week or placebo, 12% of the actively-treated patients had progressed by at least one unit on the Kurtzke Expanded Disability Status Scale (EDSS), compared to 20.1% of patients on placebo. At two years, 36.3% of the placebo patients had progressed, compared to 22.6% of interferon patients. Based on an analysis of this data, Dr Jacobs and colleagues suggest that predictions of the median time to progression by 1 EDSS unit were 3.1 years for placebo patients and 5.4 years for interferon patients.