NorthWest Biotherapeutics Inc (NWBO)

[sharpie510]

Donna posted this on facebook. It is public information. Someone else also replied in the comments about knowing someone that had to go to Germany to get treatment.

https://www.facebook.com/groups/FAMILYFOREVERJP/permalink/2008858379128771/

LETTER FROM THE SPECIALIST SO FAR

The DCVax –L Phase III clinical trial that we recently conducted was for adult patients between 18 and 70 years old who have been newly diagnosed with GBM. Those patients must have had surgery at one of the participating trial sites and must have met a number of other specific criteria to be accepted into the clinical trial. The clinical trial has completed its cohort and, although patients already in the trial continue to receive treatment, we are not enrolling new patients.

The only access to DCVax-L outside of the clinical trial is through the UK Specials Program. The vaccine has been available on a very limited compassionate use/private pay basis under the UK’s “Specials” regulation which permits certain patients with no other treatment options to receive an experimental drug outside of a clinical trial. There is a wait list for the UK Specials Program, with a backlog of patients in the queue.

Northwest Biotherapeutics manufactures DCVax-L by combining the patient’s own immune cells (the dendritic cells, which are obtained through a specialized blood draw) with biomarkers obtained from the patient’s tumor tissue. As a result, we are able to create a personalized vaccine that is injected into the upper arm like a "flu" shot. The goal is to initiate the immune response against the patient’s own cancer cells. Unlike chemotherapy, side effects from administration of the vaccine are minimal - some redness may occur at the injection site and occasionally a low-grade fever develops.

In order to produce DCVax-L, two to three grams of frozen tumor tissue are usually required to make the eleven-shot three-year cycle of DCVax-L injections. If your nephew has stored frozen tumor tissue, it must have been saved without any chemicals or preservatives and may not be in saline or blocks of paraffin. Unfortunately tumor banks and pathology departments frequently use paraffin or other preservatives that render the tissue unusable for the DCVax-L manufacturing process. Since your email inquiry did not indicate whether your nephew already has had surgery, it is important to note DCVax-L cannot be prepared without sufficient frozen untreated tumor tissue.
Even with sufficient tumor tissue, there is no guarantee that: (a) Jayden would be eligible to enter the UK Specials Program due to changes in his medical condition that might be present at the time his name appears at the top of the UK Specials Program wait list, since his medical condition must be evaluated by UK physicians prior to entry into the Program, or (b) the vaccine can be manufactured – we need both sufficient tumor tissue to make a tumor lysate and sufficient dendritic cells to manufacture the vaccine. It is a two-step process that is variable based upon each individual patient. The vaccine is manufactured in such a way that the tissue’s antigens are used to “educate” the dendritic cells and millions of those educated dendritic cells become the vaccine. Once injected, the vaccine serves to initiate an immune response against the cancer by recognizing those tumor antigens.
In addition, the fact that Jayden is only 17 means he would not currently qualify for the treatment protocol for the UK Specials Program. It may take until the end of August for Jayden’s name to get to the top of the wait list, however, so we can certainly place his name on the list once we receive confirmation there is sufficient frozen tumor tissue.
DCVax-L is a treatment option that is given in addition to standard of care treatments. Even though the earlier clinical trials have produced significant data with regards to recurrence and life expectancy, it is not considered a cure for GBM.

It is important for you to know if your nephew does have the opportunity to participate in the UK Specials Program at some time in the future, he will need to be able to travel to facilities in London, UK for the leukapheresis process (to obtain the blood product which is necessary to manufacture the vaccine) and all of the injections of DCVax-L would be administered in London under the oversight of a UK physician. The costs for travel and accommodation, as well as private physician fees, and shipping costs, are borne by the patient in addition to the cost of manufacturing the vaccine and for the release of the individual doses. It is not an insignificant cost, I’m afraid.

Donna, I am so sorry to learn that your nephew is fighting brain cancer – it is a discouraging diagnosis, as we well know. If DCVax-L does not prove to be an option for him, I hope he will be able to find other treatments that slow or better yet halt the progression of his cancer. I look forward to hearing from you.