Part 2 of 3 Larry Smith reply from February 2013.
"Because ICT-107 only works in a certain immune type (HLA A1 and A2 positive) it is not applicable to the entire glioblastoma population. In the phase I/II trial of ICT-107, the company screened 278 patients, but only 124 patients were randomized and enrolled in the trial. Over 50% of patients screened were excluded, primarily because of the immune typing issue. Some investors have not understood that this is a 124 patient trial, not 278 patients.
5. NWBO's phase III trial has a better chance of reaching statistical significance because it is so much larger. The size of IMUC's trial (number of patients) is relatively small in relation to the anticipated difference in treatment outcome (6 months of additional survival), and may be underpowered.
6. NWBO's trial has been approved as a Phase III trial by two different regulators: the US FDA and UK MHRA. IMUC's trial has only been approved as a phase II trial by one regulator (the FDA).
7. NWBO has extensive collaborations with large marquee partners in both the US and Europe, which provides significant third party validation. There is no such validation for IMUC's technology.
8. NWBO has completed phase I/II trials in two other cancers besides brain cancer (prostate and ovarian) cancers, and both of these trials had encouraging or striking results. IMUC has not conducted any other clinical trials with any other product besides the one 16-patient Phase I trial in brain cancer with ICT 107.
9. NWBO has received more regulatory approvals for more and larger trials than IMUC. NWBO received an extraordinary scope of approval from FDA for its first-in-man, combined phase I and II trial of its DCVax-Direct product for direct injection of dendritic cell precursors into any type of solid tumor that is inoperable. This trial starts with 36 patients, and includes dose escalation and confirmation, and efficacy endpoints, not just safety. NWBO also received FDA approval some time ago for a 612-patient randomized, controlled phase III trial in prostate cancer.
IMUC has received only small phase I trial approvals beyond its current phase II trial with ICT 107. IMUC received FDA approval of a small phase I trial in recurrent GBM brain cancer (the same type of brain cancer as is already addressed in its current trial), and a 20-patient phase I trial in ovarian cancer.
10. NWBO's product lines have broader applicability to diverse cancers than IMUC's products. NWBO's DCVax-L is applicable to all solid tumor cancers that can be surgically resected. NWBO's DCVax-Direct is applicable to all solid tumor cancers that are inoperable - and FDA has approved it that broadly for trials. IMUC's products hopefully will eventually be shown to apply to several cancers, but as of now, IMUC's ICT-107 is only applicable to brain cancer and ICT-140 is only applicable to ovarian cancer. IMUC's ICT-121 targeting a single biomarker believed to be on cancer stem cells may eventually be applicable to many cancers but that is unclear as of now.
11. NWBO is positioned to be able to apply for product approval in both the US and Europe, while IMUC is only positioned in the US. NWBO is not only conducting its phase III trial in Europe, it has also established a manufacturing capability in Germany and the UK, a process that took more than two years, while IMUC is manufacturing only in the US.
In view of the above factors, I find it difficult to understand why Mr. Feuerstein is open-minded about IMUC as a company and close-minded about NWBO. I would also expect that Mr. Feuerstein would be more positive on DCVax-L than ICT-107, but for unexplained reasons he is more positive on ICT-107. I draw the opposite conclusion and find DCVax-L to be the product more likely to be successful in the current clinical trials." Continued in part 3
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