NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

No Jerry, instead of reading a couple of sentences out of context, I would suggest that it would be better to read the entire interview to understand what Dr. Linda Liau is actually saying about the difficulties in getting a real, paradigm-changing treatment (as opposed to the Optune device) for GBM approved by the FDA.

What I think she is saying is that, because of the heterogeneous nature of GBM, the standard clinical trial methods may be insufficient and outdated, and need to be modernized to capture, and include other evidence of efficacy that is more patient specific, such as real world evidence, and patient reported outcomes. (and I will add surrogate endpoints and qualifying biomarkers)


Q&A with Linda Liau
Posted on March 17, 2020 by Bill Malloy

As Chair of UCLA’s Department of Neurosurgery and the inventor of a personalized brain cancer vaccine, Dr. Linda Liau is widely recognized as one of the world’s most forward-thinking brain surgeons. Having spent more than 25 years on glioblastoma research, Dr. Liau developed the individualized treatment to work with a patient’s unique immune system to detect and attack cancer cells that remain after tumor removal.

Glioblastoma, the most aggressive type of cancerous brain tumor, usually results in death within 15 months of diagnosis. One of the biggest problems with finding a successful treatment? According to Dr. Liau, the fact that the disease is so heterogeneous – that it presents differently from patient to patient – means that the standard clinical trial approach has so far been less than helpful when it comes to identifying a cure.

So, what is the answer? Ever the pioneer, Dr. Liau thinks that comparative analysis may be a good start. Such an approach would allow physicians to treat patients individually, using real-word data to treat the patient according to what is best for them, rather than by strictly adhering to the protocols of a standard clinical trial.

I recently sat down with Dr. Linda Liau to discuss glioblastoma, the current state of clinical trials, and how a different approach is needed to eventually find a cure.

Q: What, in your opinion, is the big-picture problem with glioblastoma? 

A: I’ve been working in this area for 25 years now, and one after another, these trials fail. AbbVie had a trial just a few months ago that failed and I think biotech caption was, “Glioblastoma takes another victim.” So, I think we’re going about this the wrong way, because I think everybody’s trying to find a cure but also have a company raise money and get their company launched. But glioblastoma is such a heterogenous disease. I don’t think you could go say, “Oh, I have one drug or one treatment, one molecule target or one drug, and I am going to patent this, license it and then do a startup company. And this is how I’m going to cure GBM.”

More and more, I do think you need to think about appropriation therapies, we need to think about timing of treatments and also the whole process of getting therapies adopted through the whole hurdle of FDA approval.

The entire interview: https://billmalloy.info/qa-with-linda-liau/