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World's First Therapeutic Vaccine for Brain Cancer Commercially Available to Patients in Switzerland
BOTHELL, Washington, July 9 /PRNewswire/ --
- 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. (OTC Bulletin Board: NWBO; AIM: NWBS and
NWBT), 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
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.
Disclaimer
Statements made in this news release that are not historical facts 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 risks related to the company's ability to successfully
commercialize DCVax(R)-Brain in Switzerland, the company's ability to enroll
patients in its Phase II clinical trial of DCVax(R)-Brain and complete the
trial on a timely basis, the uncertainty of the clinical trials process, the
timely performance of third parties, and whether DCVax(R)-Brain will
demonstrate safety and efficacy and the timely performance of third parties.
Additional information on these and other factors, which could affect the
company's results, is included in its Securities and Exchange Commission
("SEC") filings. Finally, there may be other factors not mentioned above or
included in the company's SEC filings that may cause actual results to differ
materially 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.






