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Swiss 'Authorization for Use' Approved for DCVax(R)-Brain
~ Patient survival is more than doubled in both newly diagnosed and
recurrent brain cancers ~
BOTHELL, Wash., July 9 /PRNewswire-FirstCall/ -- 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, th
e 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.
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