NorthWest Biotherapeutics Inc (NWBO)

[highwayman4life]

Tried to condense with better "flow." I would like to get this out asap so pls continue to shred at will Once again, I have not added any of the attacks they have sustained but I certainly can?

Dr. Siegel,

I wanted to bring to your attention a clinical trial cancer therapy that you showcased on Fox News back in November 2013 titled, “Could our own bodies hold the key to curing cancer.” The company I am referring to is Northwest Biotherapeutics (NWBO) and their cancer vaccine is DCVax. The highlight of this piece was showcasing DCVax L which is used in the treatment of Glioblastoma Multiforme. There have been many exciting developments since then that I would like to share with you.

In March of 2014 NWBO announced that it had received “early access” Hospital Exemption (HE) from the German FDA for treatment of any glioma brain cancer. This is quite significant in the following key ways:
• the first immunotherapy;
• the first product which exerts pharmacological (i.e., drug-like) effects in the patient's body;
• the first product that has never previously been on the market commercially;
• the first product developed by a non-German company, not previously under the German regulators' oversight; and
• the first "somatic" cell therapy product (a somatic cell is any cell of the body other than a reproductive or embryonic cell).

In addition to obtaining HE, the German reimbursement authority has approved DCVaxL treatment for reimbursement from health insurers. To date, 10 Hospitals have applied for reimbursement status. This eligibility is quite rare given they are still in clinical trials.

NWBO’s second platform drug/vaccine is DCVax Direct. The Phase I/II trial of DCVax-Direct is treating patients with advanced, inoperable cancers involving multiple metastases (including metastatic colon cancer, pancreatic cancer, sarcoma, melanoma and others). Although these patients have such advanced metastatic disease, only one tumor is being injected in each patient because the current trial is a first-in-man study. This clinical trial includes a total of 60 patients: 36 in the Phase I (safety) portion and 24 in the Phase II (efficacy) portion. The DCVax-Direct trial began treating its first patients in Q3 of last year.

To date, 23 out of the 36 patients enrolled are undergoing treatments. The remaining 13 patients just started treatments in June. Now to the exciting early responses being seen:

• 13 of the 20 patients who have completed at least 3 of the 6 total treatments have shown early signs of tumor cell death, tumor shrinkage and/or stoppage of the progression of their disease
• 9 of these patients have completed 4 of the 6 treatments
• All 9 or 100% of these patients are showing positive early response of tumor cell death, shrinkage and/or stoppage of the progression of their disease
• In 3 of the 9 patients, biopsies currently show NO live tumor cells

Keep in mind that these patients have run out of treatment options and are essentially on the doorstep of Hospice Care.

Finally I would like to share two amazing stories from patients who underwent treatment in this DCVax Direct trial:

The first remarkable story was recently showcased on the charity fundraiser Stand Up 2 Cancer. The patient is Allan Butler who is the VP of the National Geographic Channel. Allan was diagnosed with Stage 4 Pancreatic Cancer and after 4 months of unsuccessful Chemotherapy he was told that there were no other treatment options left. Below is the link to the clip of Allan’s story.
http://channel.nationalgeographic.com/channel/videos/national-geographic-stands-up-to-cancer/

Allan is now 18 months post diagnosis and feeling great. This is truly remarkable given clinical studies show that 50% of such stage 4 pancreatic patients die within six months and 77% within one year. Perhaps as few as 2-3% survive beyond 18 months.

The last truly remarkable story out of this trial is involves a sarcoma patient with a large tumor mass and multiple inoperable metastatic tumors in the lung. This patient received the first 3 DCVax-Direct injections through the course of a month, starting in February. He received a fourth injection in early April and then was scanned for results in early May. At that time, this patient’s MRI scan showed extensive necrosis and partial collapse of the injected large tumor mass, and a CT scan showed some early indication of shrinkage of one of the non-injected metastasized tumors. These results suggest both local and systemic effects of the DCVax-Direct treatment, as were seen in the pre-clinical studies.

These encouraging results were further supported by tumor biopsies taken at the time of the most recent injection, which showed a high rate of tumor necrosis and appearance of T cells (immune cells) infiltrating into the injected tumor.

Given that Northwest Biotherapeutics is a small cap biotech company, they have literally been exhausting all resources with their trials, German price negotiations, setting up manufacturing infrastructure in Europe etc… What has been lacking is exposure by any media coverage here in the US. I am hoping you will once again take some time to contact this Company as well as Allan Butler and share this potential cancer treatment game changer.

Kind Regards,

Scott Hammons