Northwest Bio Fuzzier on Cancer Vaccine Study Patient Enrollment

I don't want to write about Northwest Biotherapeutics ( NWBO) all the time. Honestly, there are better ways for me to spend my time, but every time CEO Linda Powers speaks, another truth bomb explodes and I'm forced to clean up the mess.

On Wednesday afternoon during a presentation at an investor conference, Powers once again offered conflicting language on the timeline for enrollment of 312 glioblastoma patients in the phase III study of the experimental cancer vaccine DC-Vax.

Enrollment is expected to complete "this year," said Powers.

Uh oh...

Last September, Northwest Bio's guidance for the DC-Vax phase III study was, " potentially finishing enrollment by the late summer of next year." That implied this upcoming August, maybe into September if generous about summer's end.

"This year" implies ... this year! September? October? December? Powers will keep us guessing, just as she's done with the actual number of patients enrolled in the study to date, which is never disclosed. Results of the interim efficacy analysis announced last December are still MIA. And Powers disappeared any mention of the next interim analysis, which was supposed to take place after 88 patient deaths. 

As she so often likes to do these days, Powers on Wednesday talked up the global reach of the DC-Vax phase III study, which is allegedly recruiting patients in the U.S., the United Kingdom and Germany.

Except it's not. A perusal of ClinicalTrials.gov shows the number of hospitals enrolling patients stuck at 55, where it's been for a really long time. The company's most recent 10-Q filed with the SEC says there are 51 clinical trial sites open. Back in September, Northwest Bio claimed German regulators had given the clearance for the DC-Vax study to recruit patients there

It enables NW Bio to proceed with its Phase III trial in Germany, where the Company plans to include more than 20 top German hospital centers. These German centers will be joining more than 55 clinical trial sites currently operating in the US, as well as sites in the UK, as part of NW Bio's international 312-patient, double blind, randomized, placebo-controlled Phase III clinical trial of DCVax®-L for Glioblastoma multiforme (GBM), the most lethal form of brain cancer. Based upon the PEI's approval, NW Bio will now proceed with the final administrative steps with the individual German hospital centers, in order for enrollment to begin.

Nine months have passed and none of those 20 promised German hospitals are listed on ClinicalTrials.gov. Northwest Bio has had a problem in the past translating English into German and vice versa, so perhaps that's the holdup. Let's not forget the other red flags waving above the DC-Vax phase III study: A questionable choice of primary endpoint and dodgy statistical analysis plan.

And let's not even get started on how many more delays will occur if/when Northwest Bio decides to add patients to the GBM DC-Vax study. That's the next truth bomb waiting to drop.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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