Is 34% relative reduction(modest decrease) worth further trial?
HINT-2 90% readings:
The primary outcome measures were 1) safety and tolerability of TSO and 2) changes in the number of gadolinium enhancing lesions (Gd+) during monthly brain MRI scans with double-dose gadolinium contrast which were read in random order by three masked radiologists.RESULTS: No significant safety or tolerability issues were observed. With 90% of timepoints analyzed to date, the mean number of Gd+ lesions per month was 3.2 during 5 months of observation and 2.1 during the last 5 months of treatment, a 34% relative reduction. Immunological assessments indicated that TSO was associated with increases in T regulatory cells and a modified Th2 immune response. Transcriptional analyses of peripheral blood mononuclear cells suggested that treatment led to diminished expression of the pellino E3 ubiquitin protein ligase 1 (pelli 1) gene, recently demonstrated to be a central activator of microglia in experimental autoimmune encephalomyelitis and possibly in MS itself.CONCLUSIONS: TSO appears safe and well-tolerated in RRMS subjects. The modest decrease observed in numbers of Gd+ lesions during treatment indicates that further studies if TSO will be required to assess its effectiveness in RRMS.
CNDO does not appear to think so. I spoke with a high level person there who pointed me to the published abstract. My strong feel was that they do not think the results were strong enough to continue in MS. I think this is also fairly obvious from all of CNDO's recent statements. (I think I read somewhere that true phase 2 MS trials generally have 100-200 subjects-think about how long that would take it took years to run the HINT 2 trials with just 10 patients).BTW how stupid was Fleming to say "modest". He could just as easily have said "encouraging", especially since he wants further study of MS. Who knows though I think Fleming presents in a few days maybe there will be a surprise...
I did a google search and found ONO-4641 had a much higher Gd+ changes. Seems the scientists will have a hard task to persuade FDA and doctors to adopt the new method of immune modulation, long term usage of natural method vs chemicals. I think it may easier for normal people to accept this idea than doctors at FDA.