2nd DEOXYSPERGUALIN TRIAL DISAPPOINTS

Hoechst's Behringwerke unit has published disappointing results from a second Phase III study of its potential multiple sclerosis treatment deoxyspergualin. The interim analysis of the six-month data from the trial showed no clinical or statistical significance, and so did not back up the results seen from the six-month or one-year data from the first study, which were at the same time as the data from the second study. DSG was originally developed by Nippon Kayaku of Japan.

In the first DSG study, 104 patients (75% with relapsing-remitting or relapsing-progressive disease and 25% with with secondary progressive disease) from Switzerland, Germany and France were randomized to receive either placebo, low-dose DSG (2mg/kg) or high-dose DSG (6mg/kg) by three-hour infusion daily for four days and then five cycles separated by one month. The drug was well-tolerated, according to Behringwerke.

The results of this study indicated that one-third of DSG-treated patients showed a clinical improvement, one-third had stable disease and one-third worsened, according to EDSS scores. The performance of patients in the low-dose group was equal to placebo. In the high-dose group, one-third had stable disease but more patients improved than deteriorated. Similar results were seen at one year, but no improvement was seen in brain lesions using magnetic resonance technology.