NWBS Northw.Bio Regs

 

TIDMNWBS TIDMNWBT 
 
RNS Number : 4237N 
Northwest Biotherapeutics Inc 
17 February 2009 
 

 
 
 
 
Northwest Biotherapeutics, Inc. 
("NWBT", "Northwest" or the "Company") 
 
 
Update of Long-Term Data on Brain Cancer Patients Receiving DCVax -Brain 
Continues to Show 
Striking Improvements in Delay of Disease and Survival 
 
 
BETHESDA, MD - February 17, 2009 - Northwest Biotherapeutics, Inc. (AIM: NWBT 
and NWBS; OTCBB: NWBO) today announced further long-term follow-up data, for the 
second half of 2008, from its prior Phase I and Phase I/II clinical trials with 
DCVax -Brain in patients with Glioblastoma multiforme, the most rapid and lethal 
type of brain cancer. During the update period from June 15, 2008, through 
January 1, 2009, none of the twenty patients treated with standard of care plus 
DCVax -Brain died. So far, now, 68% of patients treated with DCVax -Brain have 
lived more than 2 years, 63% have lived more than 2-1/2 years, 53% have lived 
more than 3 years, 35% have lived more than 4 years and 25% have lived more than 
5 years. In contrast, patients who receive full standard of care (surgery, 
radiation and chemotherapy) without DCVax -Brain have a median survival of only 
14.6 months, and less than 5% of these patients are typically alive at 5 years. 
 
 
In addition to there being no deaths among the DCVax -Brain treated patients 
during the 2008 update period, only two of the twenty patients experienced 
progression (recurrence) of their brain cancer. One of these two patients had 
been disease free for nearly 6 years (70 months) at the time of their 
progression, and the other patient had been disease free for more than 4 years 
(50 months). In contrast, the usual time to progression (recurrence) in GBM, 
with full standard of care treatment but without DCVax -Brain, is only 6.9 
months. 
 
 
In other results from the 2008 update data period: 
 
 
  *  95% of DCVax -Brain treated patients have lived longer than the median survival 
  of 14.6 months with existing standard of care treatment; 
 
 
 
  *  Likewise, 95% of DCVax -Brain treated patients have been free of disease 
  progression (recurrence) for longer than the median progression free survival of 
  6.9 months with existing standard of care treatment. 
 
 
 
DCVax -Brain is a groundbreaking personalized vaccine that takes a patient's own 
master immune cells and the biomarkers from that patient's own tumor tissue, and 
activates the master immune cells so they can mobilize the full immune system to 
recognize and kill the tumor cells.. The 10-day manufacturing process produces 
several years of personalized vaccine for a patient, making DCVax -Brain an 
"off-the-shelf" product for that patient throughout the treatment period. 
DCVax -Brain is administered as a simple injection under the skin, similar to a 
flu shot, and is not toxic as most chemotherapies are. 
 
 
DCVax -Brain is now in a large Phase II clinical trial which is currently 
enrolling patients at 11 medical centers across the U.S. (listed at 
www.nwbio.com). 
 
 
"The long-term survival of patients treated with DCVax -Brain continues to be 
quite striking and encouraging," commented Dr. Alton L. Boynton, President and 
Chief Executive Officer of NWBT, "and it is especially exciting that this 
long-term survival is without toxicity, enabling our patients to go on with 
their lives in a normal fashion." 
 
 
GBM, the most aggressive form of brain cancer, is estimated to have caused more 
than 12,000 deaths in the United States in 2007; and brain cancer is estimated 
to have caused over 39,000 deaths in Europe in 2002 (in each case, the last year 
for which estimates are available). Beyond surgery to remove the brain tumor and 
radiation therapy, there are only two treatments for GBM patients currently 
approved by the U.S. Food and Drug Administration ("FDA"): one chemotherapy 
drug, and one drug-infused wafer for surgical implant. Those treatments have 
been shown in clinical trials to typically add only 10-12 weeks of survival in 
GBM patients. 
 
 
Since 2005, the standard of care for patients with newly diagnosed GBM has been 
surgery followed by a combination of radiation and Temodar . The studies that 
defined this standard of care, and formed the basis for the approval of 
Temodar , achieved a median overall survival of 14.6 months and a median time to 
disease progression (recurrence) of 6.9 months (Stupp, et. al., N Engl J Med, 
352:987, 2005, n = 573). 
 
 
As noted above, DCVax -Brain is a personalized immunotherapy designed to 
stimulate a patient's own immune system to fight cancer. DCVax -Brain is made up 
of the patient's own "dendritic cells," the master cells of the immune system, 
that have been activated and "educated" to mobilize the full immune system to 
recognize and destroy cancer cells bearing the biomarkers of the patient's own 
tumor. Each patient undergoes tumor removal through surgery as part of the 
current standard of care. Dendritic cells drawn from a sample of the patient's 
blood are exposed in a lab dish to the biomarkers of the patient's own tumor, 
along with certain other proprietary steps, and are thereby activated and 
"educated." These activated and "educated" dendritic cells are injected back 
into the patient, in a simple small injection under the skin, similar to a flu 
shot or insulin shot, at a series of time points several weeks apart and then 
months apart. These dendritic cells are then able to mobilize the immune system 
to recognize and attack the cancer, and do so without toxicity to the patient 
(i.e., without grade 3 or 4 adverse events). 
 
 
The Company remains in an advanced stage of negotiations with several different 
providers for additional near-term funding and longer term funding, which it 
hopes to complete during H1 of 2009. The Company will need to raise additional 
capital to fund its clinical trials and other operating activities and to repay 
indebtedness in due course. Shareholders should be aware that if the Company's 
capital raising efforts are unsuccessful, this will have a material adverse 
effect on the Company's financial position and operations. 
 
 
 
 
About Northwest Biotherapeutics 
 
Northwest Biotherapeutics is a biotechnology company focused on developing 
immunotherapy products that treat cancers more effectively than current 
treatments, without toxicity, on a cost-effective basis. The Company has two 
broad platform technologies: dendritic cell-based vaccines and therapeutic 
antibodies. The Company is currently conducting a large Phase II clinical trial 
in GBM, which is currently open and enrolling patients at 11 sites across the 
U.S. The Company has also received clearance from the FDA for a large Phase III 
trial in prostate cancer, and clearance from the FDA for Phase I trials in five 
other cancers. The Company has started, and is currently enrolling patients in, 
a Phase I/II trial with DCVax  for recurrent metastatic ovarian cancer. The 
Company's second technology platform, involving antibodies to CXCR4, is at the 
late pre-clinical development stage. 
 
 
For further information about clinical sites and Company information please 
visit the company web site at www.nwbio.com. 
 
 
 
 
Disclaimer 
 
 
Statements made in this news release that are not historical facts, including 
statements concerning future treatment of patients with GBM using DCVax -Brain 
and future clinical trials, are forward-looking statements within the meaning of 
the Private Securities Litigation Reform Act of 1995. Words such as "expects," 
"believes," "intends," and similar expressions are intended to identify 
forward-looking statements. Actual results may differ materially from those 
projected in any forward-looking statement. Specifically, there are a number of 
important factors that could cause actual results to differ materially from 
those anticipated, such as the Company's ability to raise additional capital, 
risks related to the Company's ability to enroll patients in its clinical trials 
and complete the trials on a timely basis, the uncertainty of the clinical 
trials process, uncertainties about the timely performance of third parties, and 
whether the Company's products will demonstrate safety and efficacy. Additional 
information on these and other factors, which could affect the Company's 
results, is included in its Securities and Exchange Commission ("SEC") filings 
and the Risk Factors section of the Form S-1 recently filed by the Company. 
Finally, there may be other factors not mentioned above or included in the 
Company's SEC filings or recently filed Form S-1 that may cause actual results 
to differ materially from those projected in any forward-looking statement. You 
should not place undue reliance on any forward-looking statements. The Company 
assumes no obligation to update any forward-looking statements as a result of 
new information, future events or developments, except as required by securities 
laws. 
 
 
For further information, please contact: 
 
 
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| Northwest Biotherapeutics, Inc.                                |                      | 
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| Alton L. Boynton, Chief Executive Officer                      | +1 240 497 9024      | 
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|                                                                |                      | 
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| Buchanan Communications                                        |                      | 
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| Lisa Baderoon (lisab@buchanan.uk.com) / Mary-Jane Johnson /    | +44 (0)20 7466 5000  | 
| Catherine Breen                                                |                      | 
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|                                                                |                      | 
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| Collins Stewart Europe Limited                                 |                      | 
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| Adrian Hadden/ Adam Cowen                                      | +44 (0)20 7523 8350  | 
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This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
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