Question-and-Answer Session
Operator
(Operator Instructions) Your first question comes from Han Li - Stanford Group Company.
Han Li - Stanford Group Company
First a quick question for Doug on the Interleukin lambda. Can you give a sense of the Phase II study you’re going to start in mid next year, what’s the dosing on that study; is it going to be fixed or what’s the regiment, is it a Q1 week or Q2 week?
Doug Williams
Han, it’s likely to be weekly dosing based on what we’ve seen thus far. As you are aware from the slides that I showed, we’ve not yet completed our dose escalation and so I’m not yet certain that we have identified the final dose or the most optimal dose for the molecule at this point in time.
If I had to look at it today, I’d say the 1.5 microgram dose on a weekly basis would be the dose that we would move forward on. The question of whether we move to flat dosing or whether we stick with per-kilogram dosing is a question that we haven’t answered yet.
I think in Phase I, what we want to do is to establish a very clear relationship between exposure and efficacy and/or toxicity and so we are approaching the Phase I study in a very straightforward manner to understand the drug first and then we’ll make a decision on whether flat dosing is appropriate and acceptable for the drug once we know more about it, but you have to know your drug a little bit better before you simply pick a flat dose and go forward with it and that’s the way the Phase I has been designed.
Han Li - Stanford Group Company
On the safety front, have you monitored the immunogenicity of the Interleukin lambda?
Doug Williams
We have. I don’t believe we have that data available yet, but certainly with every recombinant protein that you take into the clinic, that’s part and parcel of the safety assessment that you would do.
Han Li - Stanford Group Company
So will we hear an update on immunogenicity in the upcoming quarters or --?
Doug Williams
Yes, we will. I would suspect that the easel meetings where we have the ribavirin data will be able to provide you more color on the immunogenicity results as well.
Han Li - Stanford Group Company
Okay and those are potential partnerships, I know you are in discussions, but let’s say by upcoming mid ?09, if there’s no partner signed up, are you going to take the program alone into Phase II?
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