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.
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SOURCE Northwest Biotherapeutics, Inc.
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Related links:
http://www.nwbio.com
CONTACT:
Alton Boynton, +1-240-497-9024, for Northwest
Biotherapeutics, Inc.
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