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NWBS Northw.Bio Regs

13.00
0.00 (0.00%)
24 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Northw.Bio Regs LSE:NWBS London Ordinary Share COM SHS USD0.001 (REGS)
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 13.00 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

DCVax®-Brain Update

11/09/2008 7:00am

UK Regulatory


    RNS Number : 1912D
  Northwest Biotherapeutics Inc
  11 September 2008
   

 For immediate release  11 September 2008

    Northwest Biotherapeutics
    ("NWBT" or the "Company")

    Long-Term Phase I and Phase I/II Trial Data 
    Continue to Show Striking Improvement In Survival of Brain Cancer Patients Who Receive DCVax®-Brain

    BETHESDA, MD - September 11, 2008 - Northwest Biotherapeutics, Inc. (OTCBB: NWBO; AIM: NWBT and NWBS) ("NWBT" or the "Company") today
announced the most recent long-term follow-up data, through June 15, 2008, from its prior Phase I and Phase I/II clinical trials with
DCVax®-Brain, which began in 2000 and 2003, for patients with Glioblastoma multiforme, the most lethal type of brain cancer. This long-term
data shows that 84% of patients who received DCVax®-Brain in these trials have so far lived longer than the median survival of 14.6 months
under standard of care, 68% of the patients have so far lived more than 2 years, 58% of the patients have so far lived more than 2-1/2
years, 42% have so far lived more than 3 years, and 26% have so far lived more than 4 years, with patients surviving as long as 8 years to
date. The median survival in the patients from these trials is now 36.4 months, under a standard Kaplan Meier analysis.

    DCVax®-Brain is a groundbreaking personalized vaccine that takes a patient's own immune cells and trains them in the laboratory to
attack the biomarkers from that patient's own 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 chemotherapies are. 

    The most recent data provides an update for the period since December 31, 2007, concerning both disease progression and overall
survival. During that period, only one of the nineteen patients experienced disease progression (at 59.5 months), and only one patient died
(at 37.8 months). 

    The long term data from these clinical trials shows that more than 80% of the patients who received DCVax®-Brain showed a clinical
response. In contrast, the typical response rates for cancer drugs are in the range of 20 to 25% of patients, and have been as low as 13% of
patients with some approved cancer drugs.   

    DCVax®-Brain is now in a large, Phase II clinical trial designed and powered as a pivotal trial, which is currently enrolling patients
at 11 medical centers across the U.S. (listed at www.nwbio.com).  

    Two leading physicians participating in the trial had the following to say:

    "For the first time in the fight against cancer, we are not using a toxic approach to treatment. DCVax®-Brain uses patients' own immune
cells and own tumor material, and does not cause the kinds of toxic side effects seen with typical cancer treatments.  DCVax-Brain is
helping lead the way to new patient-friendly treatment approaches," said Dr. Michael Gruber, Clinical Professor of Neurology and
Neurosurgery, NYU Cancer Institute in New York and Overlook Hospital in New Jersey, two of 11 sites of the clinical trial.

    "The ongoing results from the prior clinical trials with DCVax®-Brain continue to be very encouraging and exciting. This experimental
treatment is breaking new ground in the extension of patients' survival with the most lethal form of brain cancer. This revolutionary
approach may allow our patients to live longer, healthier, productive lives," said Dr. Steven Brem, Chief, Neuro-Oncology and Director of
Neurosurgery at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, FL, another active site in the clinical trial.

    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 defining this standard of care achieved a median time to progression of 6.9 months and a median overall survival of
14.6 months (Stupp, et. al., N Engl J Med, 352:987, 2005, n = 573). Further data from UCLA has demonstrated a somewhat longer median time to
progression of 8.1 months, and median overall survival of 17.0 months, in selected patients with GBM who received the same standard of care
(n=119). 

    In comparison, the long-term follow-up data as of June 15, 2008, for patients who received DCVax®-Brain in the two prior clinical trials
is now as follows:
    * The median overall survival in patients from these two trials is now 36.4 months, as determined by standard Kaplan Meier analysis;   
* The median time to disease progression (tumor recurrence) is now 18.1 months;    * 90% of the patients for these trials patients have
surpassed the standard of care median time to progression of 6.9 months;    * 84% of the patients have surpassed the standard of care median
overall survival time of 14.6 months;    * To date, 68% of patients receiving DCVax®-Brain in addition to standard of care have lived longer
than two years, 58% have lived longer than 2 1/2 years, 42% have lived longer than three years, and 26% have lived longer than four years;

    Dr. Alton L. Boynton, President and Chief Executive Officer of NWBT commented, "We continue to be encouraged by the long-term survival
data of the patients treated in these studies, which suggest that treatment with DCVax®-Brain has the potential to more than double the time
to tumor recurrence, and more than double survival time for patients suffering from this dreadful disease."  

    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"). Those treatments have been shown in clinical trials to typically add only 10-12
weeks of survival in GBM patients. 

    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 "educated" 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). 

    Financials 

    The Company previously announced on August 20, 2008, that it had approximately $1.1 million of cash on hand. The Company estimates that
its available cash is sufficient to support its day to day operations through to the end of September 2008. It therefore needs to raise
significant additional capital to fund its clinical trials and other operating activities and to repay indebtedness.  The Company continues
to be in late stage discussions with several parties in regard to additional financing transactions. Shareholders should be aware that if
the Company's capital raising efforts are unsuccessful, this will have a material adverse effect on the Company 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 designed and
powered to serve as a pivotal trial. 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 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:

 Northwest Biotherapeutics
 Alton Boynton, President and Chief Executive Officer      +1 240-497-9024

 Buchanan Communications
 Lisa Baderoon (lisab@buchanan.uk.com) / Mary-Jane         +44 (0)20 7466 5000
 Johnson / Catherine Breen 

 Collins Stewart
 Adam Cowen/Adrian Hadden                                  +44 (0)20 7523 8230




This information is provided by RNS
The company news service from the London Stock Exchange
 
  END 
 
MSCSFUEFSSASELU

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