|A Disturbing Lack of Information From Northwest Bio's DCVax Ph2 Trial|
|By Brian Wilson - Lead Contributor|
|Sunday, 18 May 2014 23:39|
Last week, the cancer immunotherapy company Northwest Biotherapeutics (NWBO) issued a press release discussing a case study from their Phase II trial for DCVax-Direct in the treatment of solid tumors.
This case study discussed the relatively positive outcome experienced by one patient who enrolled into the trial with an inoperable solid tumor caused by a sarcoma.
After four total injections of DCVax-Direct, the patient saw reduction of tumor mass and signs of tumor shrinkage at a distant site. Safety and tolerability of DCVax was never discussed in this case study, and it isn't clear whether the patient's tumor shrinkage was based on standardized RECIST Criteria.
Gullible traders bought NWBO en masse until it became clear that the company had blasted out a useless piece of news specifically designed to pump the retail-owned stock. This is why NWBO briefly approached $7.00 per share on the morning of May 15th before it crashed back into reality. Although this sudden spike seemed to have stopped the long-term downtrend in NWBO, the company is running out of ways to promote itself.
Lesson Learned: Statistical significance matters!
Although this case study demonstrated one good outcome in the Phase II trial, it tells us nothing about the progress of the other 59 patients enrolled in the trial. Without this information, we cannot tell whether DCVax-Direct is actually responsible for this patient's positive outcome.
In fact, we can't disprove the theory that Northwest Biotherapeutics specifically chose the patient from the trial with the best outcome for the case study - ignoring dozens of other patients who did not respond to DCVax-Direct. Because of this, we can say that the results of this case study are (very) vulnerable to selection bias.
With ASCO 2014 right around the corner, one should also be suspicious that Northwest Bio does not plan to release any efficacy data from the Phase II trial at the conference.
So what do the actions of Northwest Biotherapeutics imply?
When analyzing the behavior company, its important remember recent history. CEO Linda Powers promised to release interim data from this specific trial nearly 5 months ago, which means that we should already have this information. However, the former Enron VP seems very eager to delay this release as much as possible.
We presume that the very delayed release of the interim efficacy data, and the release of this useless case study, tells us that Northwest Biotherapeutics is stalling the inevitable release of bad Phase II data that would probably kill the DCVax-Direct program outright. Since the DCVax-Direct trial is expected to finish in June 2015, we believe that Linda will try to drag everything out until H1 2015.
Because the DCVax-Direct program is based on technology similar to DCVax-L and DCVax-Prostate, investors would naturally associate the failure of DCVax-Direct with the eventual failure of Northwest Biotherapeutics' entire approach to immunotherapy. This could have disastrous consequences for the share price of NWBO, and for the ability of the company to raise capital.