Cell Genesys, Inc. Q2 2008 Earnings Call Transcript

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2008-09-01 21:45:27.0

Tags: Cell Genesys Inc.

Question-and-Answer Session

Operator

(Operator instructions). Our first question then today is from the line of Joe Pantginis with Canaccord Adams. Please go ahead.

Joseph Pantginis Canaccord Adams

Hi, guys, good afternoon.

Stephen Sherwin

Hi.

Joseph Pantginis Canaccord Adams

Steve, a couple of – two-pronged question about your immunological data. You obviously came out with some very good data, which you discussed. You had two antibodies that showed very good correlation with survival and two antibodies that didn't show correlations supporting the multi-antigen approach. When do you think we might get an update with regard to identifying further antigens? And then the second question is regarding these immune type data, are you currently looking at Phase III patients' blood samples on a blinded basis, or how would you apply that to Phase III and potential commercialization? Thanks a lot.

Stephen Sherwin

Let me take those questions in turn. The analyses of the Phase II studies that I referred to are indeed ongoing. Additional data is being generated and we're quite pleased with how this story is unfolding, and it is possible that you will hear more about this even before the end of the year.

With respect to your second question, of course the analyses of the Phase III specimens have to be done in a strictly blinded manner, and of course, given the size of these studies and the number of time points, that will occur in parallel with the completion of the studies and what we hope to be doing in the future with respect to a preparation for BLA. And the reason for that is that first benefit from these data has to do with an important component of the BLA, which of course, are studies relating to the products proposed mechanism of action, and it's our view that these data, these immune response data, speak very strongly to our understanding of how this product works. After all, the hypothesis is to stimulate the immune system with GVAX prostate in such a way as to result in clinical benefit to the patient. So if we can show that there are subset of antibody responses that correlate with better outcome in the Phase III trials, we'll have a strong argument in our favor there.

You also alluded that – just the final comment to, are these biomarkers? And in the first sense, we would hope that they would be biomarkers that the clinicians in the future could use in treatment decision-making for GVAX prostate patients. If we can provide a panel of antibodies that indicate a better outcome is in store for the patient, then perhaps these could be used as correlative diagnostic tests during treatment. So that is a longer term goal, absolutely, and I think it's particularly relevant in immunotherapy products where there maybe subsets of patients, which we're not smart enough to identify now, but perhaps in the future, that could be particularly benefited by this treatment.

 

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