Update of Long-Term Data on DCVax-Brain
17 Febrero 2009 - 1:00AM
UK Regulatory
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:
+----------------------------------------------------------------+----------------------+
| Northwest Biotherapeutics, Inc. | |
+----------------------------------------------------------------+----------------------+
| Alton L. Boynton, Chief Executive Officer | +1 240 497 9024 |
+----------------------------------------------------------------+----------------------+
| | |
+----------------------------------------------------------------+----------------------+
| Buchanan Communications | |
+----------------------------------------------------------------+----------------------+
| Lisa Baderoon (lisab@buchanan.uk.com) / Mary-Jane Johnson / | +44 (0)20 7466 5000 |
| Catherine Breen | |
+----------------------------------------------------------------+----------------------+
| | |
+----------------------------------------------------------------+----------------------+
| Collins Stewart Europe Limited | |
+----------------------------------------------------------------+----------------------+
| Adrian Hadden/ Adam Cowen | +44 (0)20 7523 8350 |
+----------------------------------------------------------------+----------------------+
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCSFLSIWSUSEIE
Northw.Bio Regs (LSE:NWBS)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Northw.Bio Regs (LSE:NWBS)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024