Northwest Biotherapeutics Won't Be Staying Under The Radar For Long Print E-mail
By M.E.Garza   
Thursday, 28 April 2011 06:28
Almost two weeks ago we went out of our way to alert subscribers about some pending catalysts involving Northwest Biotherapeutics (OTCBB: NWBO) only to have shares hit a bump in the road last week. Know that things may finally be headed in the right direction.

It seems SEC officials change their mind about how they want certain companies to calculate a particular formula involving derivative liabilities that come from the issuance of certain warrants. This caused a great number of companies, including NWBO, to work out the new “way over my pay grade” accounting details in order to not only re-state and re-file some key audited consolidated financial statements. In the case of NWBO, company officials were forced to re-calculate two years’ worth of filings. It changed nothing fundamentally, but it did cause some confusion among investors.

With that finally behind them, it’s time we re-focus our attention on some of the important news developments that may be brewing behind the scenes for NWBO. We’ll do that by first focusing on some very public details involving a presentation at the recent 2011 American Association of Neurological Surgeons 79th Annual Scientific Meeting.

One of the presentations was co-authored by Dr. Linda Liau, Professor and Vice Chair of Neurosurgery and Director of the UCLA Brain Tumor Program. Those who have been following NWBO’s story will also recognize Dr. Liau’s name as the Principal Investigator for NWBO’s clinical trial of DCVax for GBM brain cancer.

The data that Liau and her colleagues presented made quite a few headlines. According to one article which appeared in Bloomberg BusinessWeek, researchers created individualized vaccines for 34 patients using brain tumor tissue and the patient's own dendritic cells, which are part of the immune system.

When joined together in a vaccine, introducing the tumor cells to the dendritic cells "trains" the immune system to recognize cancer cells and mount an attack, the researchers said.

"What we're trying to do is to train the immune system like a hunting dog," said Dr. Isaac Yang, a neurosurgeon at University of California, Los Angeles, and lead author of the study. "A hunting dog is given something to sniff. What the vaccine does is give the immune system the right 'scent' so that it recognizes the brain cancer and goes and kills it."

Again, if this sounds familiar to those of you familiar with NWBO’s dendritic cell (DC) vaccine technology platform it should.  The news has been flying just under the radar, but all the points connect and certainly hint toward the excitement we’ve been hearing about involving several foreign entities who are rumored to be in discussions to license and/or partner with NWBO.

Remember also that compassionate use of the drug in European countries is also said to be in play and that is something not even Dendreon (Nasdaq:DNDN) had or even planned for in regards to their therapeutic cancer vaccine for prostate cancer, Provenge.

These types of developments, all said to be on track and may play out in the near-term (30 to 60 day) horizon. It is safe to assume that if these events play out as we are hearing them, Northwest Biotherapeutics would move to the front of the immunotherapy vaccine pack.

When contacted to comment about these findings, officials at NWBO would not comment other than to say that “The company acknowledges how rewarding it has been to be working with Linda over the past eight years during Phase I and Phase II in connection with a whole series of clinical trials involving DCVax.”

Liau’s publication in Clinical Cancer Research, March 2011, reports on the results of another clinical trial. The study found that the dendritic cell vaccine, administered after conventional surgery and radio-chemotherapy, was associated with a median survival of 31.4 months, double the 15 months of historical controls in the published literature. In all, 23 patients were enrolled in the Phase I study, which was launched in 2003. Of those, about one-third are still alive, some more than eight years after their diagnosis.

This trial included both newly diagnosed GBM patients (i.e., patients whose brain cancer had just been discovered for the first time) and recurrent GBM patients (i.e, patients whose brain cancer had previously been diagnosed and treated with surgery, radiation and chemo and whose GBM had now recurred with the growth of a new tumor). In the most simple terms possible:

•    The prognosis with GBM is very bad for even newly diagnosed GBM patients:  typically, even after full standard of care treatment (surgery, radiation and chemo), their tumor recurs in just 6.9 months, and they die at 14.6 months from the initial diagnosis.  

•    The prognosis is obviously even worse for recurrent GBM patients:  from the time their tumor recurs, even if they have another brain surgery to remove the second tumor, they die in just a little over 7 months from the time of that recurrence.  

The timeline below illustrates this:
 


For those looking for a differentiator, NWBO’s ongoing 240-patient randomized controlled trial is only for newly diagnosed patients for 2 reasons: 

       (a) this will enable DCVax to be made available to all patients, not just those who have failed other treatments first, and
       (b) this will enable DCVax to be given early in disease when it can make the biggest difference in outcome.

The clinical trial with dendritic cell (DC) vaccine reported in Linda Liau’s peer-reviewed publication in Clinical Cancer Research showed striking extension of survival (technically called “Overall Survival” or “OS”) in both newly diagnosed and recurrent patients although, as with any treatment, the effect was bigger if the vaccine was given earlier in the course of disease:





Disclosure: None





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