Question-and-Answer Session
Operator
(Operator Instructions). Your first question comes from Michael Aberman with Credit Suisse.
Robert Blum
Hey, Michael.
Michael Aberman - Credit Suisse
I guess the first the comment that you expect is about this Phase IIa data in 2008, some of us were expecting it earlier 2008. Can you comment on that timeline? And also you've finished the first cohort. How many cohorts are expected? And is there any possibility of presenting data on a cohort-by-cohort basis given this is I would presume and open-label trial?
Robert Blum
I'll take a first dab at that, Michael, and I am going to turn over also to Andy. In terms of data guidance, we've always pointed to 2008 for the study and I think that's more reliably what can be expected. We have, as we indicated with this earnings press releases, pointed to do the fact that enrollment in the first cohort was slow. We expect that enrollment in cohorts 2 and subsequent cohorts will be faster and with that I think its better to point to 2008 for data coming out of this first Phase IIa trail.
Andy Wolff
And there is a possibility of releasing the data on a cohort-by-cohort basis. It really depends upon how quickly we enroll them and whether there is really material information within them. So, we need to be guided by the data as we see them. And currently all we've done, as I mentioned earlier, is a safety review of the data to allow us to open the second cohort. But, we don't yet have a formal analysis of any efficacy data from the first cohort.
Michael Aberman - Credit Suisse
Okay.
Robert Blum
So, were we to conduct an interim analysis that would provide an efficacy read information that would be material, we would elect to then disclose that by top-line disclosure in a press release to be then followed up by what would be expected to be a more complete analysis presented at the next appropriate medical meeting.
Michael Aberman - Credit Suisse
I guess, suppose you are probably starting low and going slow with this trial, based on the your Phase I date in healthy volunteers and your animal modeling. At about which cohort would you expect to start seeing efficacy that would might be worth doing an interim analysis, cohort 2, cohort 3?
Robert Blum
I don't think we can get into that level of detail. We haven't disclosed what would be the plasma concentrations that we would be evaluating on a cohort-by-cohort basis. What we have indicated is that this study designed to evaluate dose levels that correlate with the plasma concentrations. That overlap with what we evaluated in the Phase I, but which are focused more to lower ends of the dose response curve and where we would expect to see activity based on the pre-clinical evaluations, again, at the lower-end of the dose response curve. We would expect to see activity associated with plasma concentrations in the early cohorts, where the early cohorts allow us to get to what is designed in the trial to be the maximum plasma concentrations to be studied with subsequent cohorts intended to prolong the duration of those infusion. So it would not be expected that it would have to wait for the latter cohorts for us to be able to see the pharmacodynamic response that we anticipate based on hitting the maximum plasma concentration in earlier cohorts.
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