Tuesday, November 14, 2006

More lupus news

Hot on my previous rant around lupus is some more news. Human Genome Sciences has announced positive results for its Lymphostat B drug in lupus. I won't go into detail on their results, other than to comment that the study size is large (>300), the trial is a Phase II double-blind placebo controlled trial (open label, single arm trials are much more common for Phase II -- HGS isn't taking the easy route) but these results haven't yet been subject to full peer review in a journal article.

Lymphostat B has a number of unusual historical notes attached to it. It is in that very rarified society of discoveries from genomics which have made it far into therapeutic clinical trials -- there are other examples (not on hand, but trust me on this!), but not many. It doesn't hurt that it was in a protein family (TNF ligands) which suggested a bit of the biology (e.g. a cognate receptor) & has led to quite a bit of biology which is in the right neighborhood for a lupus therapy (B-cell biology); most genomics finds were Churchillian enigmas.

Second, this is a drug that initially failed similar trials -- but HGS conducted a post-hoc subset analysis on the previous trial. However, instead of begging their way forward (such analyses get all the respect due used cat litter, but that doesn't stop desperate companies from trying to argue for advancement) they designed a new trial using a biomarker to subset the population. If their strategy works, it is likely that doctors will only prescribe it to this restricted population. HGS has, in effect, decided it is better to treat some percent of a small population than risk getting approval for 0% of a larger one -- a bit of math the pharmaceutical industry has frequently naysayed.

HGS and their partner GSK still have a long way to go on Lymphostat B. Good luck to them -- everyone in this business needs it, especially the patients.

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