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Re: ospreyeye post# 2977

Saturday, 12/21/2013 1:02:36 PM

Saturday, December 21, 2013 1:02:36 PM

Post# of 700561
Ospreyeye, Response Post 1 of 3.

Feuerstein believed in ICT-107 over DCVAX for a very long time before the disappointing (but not necessarily fatal) results from ICT-107's phase 2 results. Now he feels obligated to scream twice as loud and illogically against NWBO.


On February 15, 2013, Feuerstein saw enough difference to favor ICT-107. Mr. Smith however, in a February 19, 2013 reply defended DCVAX chances.



Here is the relevant conversation.


"11. Adam Feuerstein: I'm skeptical about ImmunoCellular but with an open mind waiting for data at year's end from the first adequately designed study of ICT-107. Northwest Biotherapeutics is much more difficult to take seriously given the company's checkered past and present.

SmithOnStocks: Of all the comments that Mr. Feuerstein has made, I find this to be the most puzzling as to why he is open-minded about IMUC and close-minded about NWBO. Let me go through some important points to consider.

1. Both ImmunoCellular and Northwest Biotherapeutics are basing their studies on small phase I/II data sets. There were 16 patients in the ICT-107 study and 20 in the trials of DCVax-L. The results (as reported by the companies in their investor presentations) were remarkably similar as progression free survival was 16.9 months for ICT-107 and 26.4 months for DCVax-L. Median overall survival was 38.4 months for ICT-107 and 36.4 months for DCVax-L.

2. Both IMUC and NWBO are comparing the results of their phase I or I/II trials to the clinical results in matched patients treated with standard of care. The companies use different methods of portraying the comparison but both are doing so. Mr. Feuerstein was fiercely critical of the chart in which NWBO compared its Phase I/II data with matched controls.

3. NWBO is now in a Phase III trial while IMUC is in a Phase II trial. In his presentation at the BIO CEO conference in early February, the CEO of ImmunoCellular described the ongoing 124 patient ICT-107 trial as a phase II trial and stated that he believed the company would have to do a confirmatory phase III trial before seeking regulatory approval. Mr. Feuerstein did not indicate whether he believes this is a phase II or phase III trial, but other bloggers have mistakenly stated that it is a phase III trial.

4. NWBO's current 312 patient phase III trial is nearly three times the size of IMUC's current 124 patient phase II trial. There is a widespread misconception about the patient size of the IMUC's current trial." -- February 19, 2013 -- Continued next post.
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