Replies to post #163996 on Biotech Values

[hirogen]

XOMA-

My conclusion as well - and to state the obvious, indicating that VH piece was lower than 50% and thus potentially much less potent than Gev appears to be. But obviously with all the risk that always comes with comparing across trials.

Yep that's what I've been pondering over. It's been difficult, if not impossible to separate out VH response from all these single arm TNF-a inhibitor trials. Even if specifically defined as a component in the composite endpoint, response rate data is usually wrapped up with some other metric. From these trials and the ph I in Behcet's I think Gev is an active drug in NIU. But, as we discussed, though all 7 patients were classified as responders in the ph I, only 1 patient would have qualified for Eyeguard-A. With the recently reported ph II data where 11 would have qualified for Eyeguard-A and 8 were VH responders, the rate, while impressive, appears to be much higher than the TNF-a inhibitors.

There are a little more data on improvement in visual acuity and from the Ozurdex trial the response rates were similar between VH and BCVA. My thought is that there should be a decent correlation as significantly reducing VH should translate to improved vision (even if other inflammation factors are involved). But this has also proven to be messy in trying to sort out. The article linked below is of a study to improve VH grading concordance. I found more interesting the info on complexities, limitations of the current grading system.

I suppose where I'm going with all this is I don't know how well the primary endpoint in the ph III A trial captures the overall effect that Gev has on the disease. Which goes back to my earlier comment that I'm not sure if the trial is as well powered as XOMA thinks it is.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3220938/