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Northwest Biotherapeutics Inc DI
09 July 2007
For immediate release 9 July 2007
Northwest Biotherapeutics
('NWBT' or 'the Company')
World's First Therapeutic Vaccine for Brain Cancer
Commercially Available to Patients in Switzerland
Swiss 'Authorization for Use' Approved for DCVax(R)-Brain
Patient survival is more than doubled in both newly diagnosed and recurrent
brain cancers
Northwest Biotherapeutics, Inc. (AIM: NWBS and NWBT; OTC BB: NWBO.US), is
pleased to announce that it has received Authorization for Use from the Swiss
Institute of Public Health (Bundesamt fur Gesundheit; 'BAG') to make DCVax(R)
-Brain commercially available for treatment of brain cancer patients in
Switzerland. As such, DCVax(R)-Brain is the first commercially available
therapeutic vaccine for such cancers. The Company intends to begin making the
product available to patients in Q3 2007.
Dr. Alton Boynton, President and CEO of Northwest Biotherapeutics, said: 'We are
delighted to be the first company to reach the market with a personalized
therapeutic vaccine for brain cancers, which carry a very bleak prognosis for
patients today. We look forward to providing DCVax(R)-Brain at leading medical
centers and hospitals in Switzerland. Switzerland is an attractive place to
begin commercialization, due to its highly respected regulatory oversight, and
its growing experience with cellular therapies. Switzerland is also
increasingly noted for medical tourism, and is easily accessible for many
medical tourists. We look forward to being able to bring DCVax(R)-Brain to
patients in additional countries, and to applying our DCVax(R) technology to
many other cancers, including the five for which we already have FDA clearance
to begin clinical trials.'
'Finally, we are especially pleased to achieve such a major milestone
substantially ahead of schedule and so soon after our flotation on the AIM
market of the London Stock Exchange.'
Brain cancers can strike all ages, and are the leading cause of cancer deaths in
children under the age of 20. Brain cancers are among the most rapidly lethal
cancers: with the limited treatments available today, even newly diagnosed
patients have a median survival of only 14.6 months. In clinical trials, both
newly diagnosed and recurrent brain cancer patients treated with DCVax(R)-Brain
had more than double the survival time of patients who did not receive DCVax(R)
-Brain (to over 33 months and continuing -- median not yet reached - for newly
diagnosed patients). In addition, unlike chemotherapy, DCVax(R)-Brain does not
cause any debilitating side effects.
Under the Swiss Authorization for Use, the Company is permitted to manufacture
DCVax(R)-Brain in the US and make it available for the treatment of patients
with brain cancer at select centers in Switzerland. The Authorization was
granted in response to the Company's application in mid-February, 2007. It was
based upon the Company's clinical data to date, and upon an extensive inspection
by Swissmedic (the Swiss Agency for Therapeutic Products) on behalf of the BAG.
NWBT's DCVax(R) is a platform technology which is anticipated to be applicable
to most cancers. DCVax(R) works by mobilizing the full spectrum of immune
response, both innate and adaptive, rather than just single immune agents such
as antibodies alone or T cells alone. As such, DCVax(R) mobilizes the patient's
immune system to function in its normal, natural way. This leads to both
improved efficacy and lack of problematic toxicities. Unlike conventional cancer
drugs, DCVax(R) does not cause any debilitating side effects.
DCVax(R) products are personalized treatments, made by combining a patient's own
master immune cells (dendritic cells) with cancer biomarkers derived from or
displayed by the patient's own tumor. Precursors of the master immune cells are
continuously circulating in a patient's blood and are obtained through a blood
draw. The master immune cells are then matured and activated through a series of
proprietary steps, then 'educated' by exposure to the patient's tumor
biomarkers, and injected back into the patient through a simple intradermal
injection in the arm or thigh, consisting of just a few drops.
Unlike many personalized therapies under development, DCVax(R) products will be
cost-effective. The key to their cost-effectiveness is a proprietary batch
manufacturing process pioneered by NWBT, through over 10 years of development,
under which a single manufacturing run is used to produce at least 3 years of
personalized treatments for a particular patient. The treatments are stored
frozen in single-dose vials, ready for use on an off-the-shelf basis for that
patient. Such storage is highly reliable and low cost. By doing only one
manufacturing run, and thereafter having the product available off-the-shelf,
NWBT is able to keep the costs of its personalized vaccines at a level that can
enable product pricing in a range comparable to other cancer drugs.
In parallel with making DCVax(R)-Brain commercially available to patients at
selected medical centers in Switzerland, NWBT is also conducting a Phase II
pivotal trial in 141 patients in the US. The trial began enrolling patients in
December 2006, and is anticipated to conclude around the end of 2008. The
Company plans to seek product approval in both the US and EU in early 2009,
based upon the results of the Phase II pivotal trial.
DCVax(R)-Brain has been granted orphan drug status in both the US and the EU.
Such status will afford DCVax(R)-Brain 7 years of market exclusivity in the US
and 10 years in the EU, if DCVax(R)-Brain is the first product of its type to
reach product approval.
Clinical trial data to date in brain cancer patients have shown that DCVax(R)
-Brain delays disease recurrence by nearly 3-fold, from 6.9 months to 18.1
months for newly diagnosed patients. DCVax(R)-Brain also extends these
patients' survival from 14.6 months to more than 33 months (and continuing -
median not yet reached).
The DCVax(R) Technology platform is anticipated to be applicable to most
cancers. NWBT is already at the Phase III, pivotal trial stage in prostate
cancer, and has also received FDA clearance for clinical trials in five other
cancers (including lung cancer, the leading cause of cancer deaths worldwide).
Clinical trial data to date in hormone independent prostate cancer patients have
shown striking results similar to the results in brain cancer
For further information, please contact:
Northwest Biotherapeutics
Linda F. Powers, Non-Executive Chairperson +1 240-497-4060 or
+1 240-441-6047
Buchanan Communications
Lisa Baderoon (
lisab@buchanan.uk.com)
/ Mary-Jane Johnson / Catherine Breen +44 (0)20 7466 5000
About Northwest Biotherapeutics, Inc.
Northwest Biotherapeutics, Inc. is a US-based 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:
(1.) dendritic cell-based therapeutic vaccines and (2.) antibody drugs. The
Company's lead product candidates are:
1. DCVax(R)-Brain, a personalized dendritic cell vaccine for treatment of
Glioblastoma multiforme, which has reached the market commercially in
Switzerland and, in parallel, has been under way since December, 2006, in a
Phase II pivotal clinical in the US which is expected to finish around the end
of 2008; and
2. DCVax(R)-Prostate, a personalized dendritic cell vaccine for treatment
of hormone independent non-metastatic prostate cancer, which has been cleared by
the FDA to enter a Phase III pivotal clinical trial in the US