NWBO’s Interim Data: Completely Worthless Print E-mail
By Brian Wilson - Lead Contributor   
Thursday, 12 June 2014 09:18

Yesterday, traders sent Northwest Biotherapeutics (NWBO) 11.87% higher after the company released an 8-week interim data readout  from a Phase I/II trial for the product DCVax – an immunotherapy being developed for inoperable solid tumors.

The headlines suggest that 9/9 of the patients that received 4/6 injections of the product saw tumor cell death, tumor shrinkage, immune cell activity, or stabilization of their advanced cancer.


Stabilization is the key word here, because it allows Northwest Bio to suggest that all 9 patients had a positive response to DCVax at week 8 of the 32-week trial. However, the truth is that the company’s press release ultimately tells us nothing about the efficacy of DCVax in solid tumors, and we saw no information discussing the safety and tolerability of DCVax in patients. Because the study is primarily a safety/tolerability study, we now start to worry that DCVax might be causing serious adverse side effects in cancer patients that are not being discussed by the company.


But going back to the efficacy data, we will explain why the information presented was not at all meaningful to those who understand clinical trial data.

 

According to RECIST criteria (the standardized criteria for measuring tumor response), “stable disease” simply means that a patient’s tumors did not grow 20% or more by size or shrink by 30% or more. After just 8 weeks of immunotherapy, it’s not surprising (at all) to see that none of the patients saw tumor growth of 20% or more. Even a placebo could have caused these so-called “positive effects.” And what about patients who saw tumor growth <20% within that 8-week timeframe?


The tricky wording of the ambiguous press release makes it difficult to understand just how “positive” the data readout from the Phase I/II trial actually is, and we are concerned that investors are being misled into thinking that DCVax is showing real signs of efficacy against inoperable tumors.


We are also suspicious about the timing of this press release, and we see this PR spin as a potential precursor to an ATM financing. Northwest Bio is running low on cash (with $12 M as of March 31st 2014), and we believe that the company is looking to raise money for its Phase III trial in the near future. This interim data release is an excellent way to boost the share price ahead of an offering, and it helps to distract investors from sluggish enrollment into NWBO’s Phase III Glioblastoma trial.


So ultimately, investors should consider that none of the efficacy results that were presented in the press release were statistically significant – meaning that there is no evidence that the results actually have anything to do with DCVax. Sophisticated biotech investors would generally disregard any information related to the efficacy of a therapy unless it was analyzed statistically, and it would generally have to show a p-value lower than .05.


Because Northwest Bio only analyzed 9 patients in this interim study, and because there is no control group, the efficacy data presented had no p-value and were meaningless. Despite this, it seems that a large number of investors were tricked into thinking that NWBO presented something overwhelmingly positive yesterday. The truth is that NWBO presented a ridiculously ambiguous dataset that leaves open the possibility that DCVax is not having any noticeable effects on the majority of cancer patients. If this were the case, we believe that DCVax would probably fail the all-important overall survival and progression-free survival endpoints in the Phase I/II trial.




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