BETHESDA, Md., Sept. 11 MD-Northwest-Biother
BETHESDA, Md., Sept. 11 /PRNewswire-FirstCall/ -- Northwest
Biotherapeutics, Inc. (OTC Bulletin Board: 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(R)-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(R)-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(R)-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(R)-Brain an "off-the-shelf" product for that patient throughout the
treatment period. DCVax(R)-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(R)-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(R)-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 http://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(R)-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(R)-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(R). 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(R)-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(R)-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(R)-
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(R)-Brain is a personalized immunotherapy designed to
stimulate a patient's own immune system to fight cancer. DCVax(R)-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(R) 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 http://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(R)-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.
SOURCE Northwest Biotherapeutics, Inc.
