Expert Financial Analysis and Reporting

Adam Feuerstein has consistently disagreed with authors who believe that there is a sound basis for Northwest Biotherapeutics (NWBO) conducting a phase III trial of DCVax-L in glioblastoma; I am one of those authors. I have never maintained that the trial will unquestionably succeed. I acknowledge that phase III trials conducted by both large and small companies fail with some frequency; we all know this. Also in dealing with a paradigm shifting technology like dendritic cell cancer vaccines, we have to acknowledge that there is even higher risk of failure than the norm.

The difference between Feuerstein’s and my position is that I think there is a reasonable chance for success; he believes there is no chance. He has commented frequently on my articles and those of other authors. I have asked him to explain his views in more detail so that we might all learn from him. Today, he has taken up that request and provides his in-depth analysis of Northwest Biotherapeutics and dendritic cell therapy in his column on TheStreet.com. I thought that Seeking Alpha readers could benefit from his analysis and I have included his article verbatim. It is always important to understand and respect different points of view.
He says:

“Let's squash this silly notion that the blowup of ImmunoCellular Therapeutics’ (IMUC_) dendritic brain tumor vaccine last week is an isolated incident without negative consequences for Northwest Biotherapeutics (NWBO_) and its nearly identical dendritic brain tumor vaccine.

I hate to break the bad news to Seeking Alpha contributor Josh Ginsburg, but Northwest's DCVax is not different from ImmunoCellular's ICT-107. DCVax will fail just like ICT-107 failed because dendritic cancer vaccines are too weak to overcome cancer's innate ability to overpower or evade the body's immune system.

The scientific community and most of Wall Street know this and have moved on from dendritic cancer vaccines. Today's buzz is antibody-based cancer immunotherapy -- the PD-1s and PDL-1s of Bristol-Myers Squibb (BMY_), Merck (MRK_), Roche (ROG_) and others which are showing incredible results in large clinical trials. A bit farther back but no less exciting is the work being done by academic researchers and Novartis (NVS_) with engineered T cells -- so-called CAR-T immunotherapy.

Last February, I explained in great detail why data from two early studies of Northwest Bio's DCVax in patients with glioblastoma multiforme (GBM) were sloppy, wrong and wildly misleading. Twenty GBM patients were handpicked for treatment with DCVax in these two phase I studies, so of course they outperformed expectations. The median progression-free survival of 26 months and median overall survival of 36 months touted by Northwest Bio as evidence of DCVax efficacy are not real. These DCVax data are a mirage which will vanish once Northwest Bio stops issuing endless promotional press releases and finally gets around to analyzing the much larger phase III study.

Seeking Alpha's Larry "Smith on Stocks" Smith was wrong about Northwest Bio last February and he's still wrong today when he whistles past ImmunoCellular's graveyard.

The bull thesis on ImmunoCellular's ICT-107 was also based on super-duper data from a small phase I study. Sixteen patients with newly diagnosed GBM were treated with ICT-107 at the prestigious Cedars-Sinai Medical Center in Los Angeles. The results were reportedly spectacular, including median overall survival of more than 38 months. Some ICT-107 patients were still alive five years after treatment. Historically, similar GBM patients enrolled in other, larger clinical trials only lived an average about 18 months, therefore ICT-107 be responsible for the prolonged survival benefit.

Um... no. Last week, ImmunoCellular announced negative results from its 124-patient phase II study of ICT-107 in GBM patients. Sure enough, the GBM patients treated with placebo lived about 18 months, as expected. The patients treated with ICT-107 survived only two months longer, on average.

What happened to the 38-month median overall survival data from the phase I study of ICT-107? Poof! Gone. A fantasy.

Don't expect any better outcome from Northwest Bio's DCVax.”