BETHESDA, Md., Oct. 14, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that the DCVax-L Hospital Exemption
Program that was approved by the German regulatory authority
earlier this year is now under way. The first patient with
Glioblastoma multiforme (GBM) brain cancer has begun the treatment
process, additional patients are being assessed and a waiting list
has been established.
NW Bio's DCVax-L is the first immune therapy to be granted a
Hospital Exemption approval under the German Drug Law. The
scope of this Hospital Exemption includes all glioma brain cancers,
both GBM (the most severe grade) and lower grade (less malignant)
gliomas, and includes both newly diagnosed (i.e., early stage) as
well as recurrent (i.e., late stage) patients. The patients
must receive treatment in Germany,
but may be either from Germany or
from abroad.
NW Bio is currently conducting a 348-patient Phase III clinical
trial of DCVax-L for newly diagnosed GBM patients, in both the US
and Europe. In two early
stage trials, prior to the current Phase III trial, patients with
newly diagnosed GBM who were treated with DCVax-L showed median
survival of 3 years. With current standard of care (surgery,
radiation and chemotherapy) median survival for such patients is
about 14.6 months.
Patients with recurrent GBM and patients with other glioma brain
cancers are not eligible for the Phase III clinical trial, but all
such patients are eligible for treatment under the DCVax-L Hospital
Exemption.
The first DCVax-L Hospital Exemption patient underwent surgery
to remove his GBM tumor last week, and the manufacturing of his
DCVax-L also began last week with the processing of his tumor
tissue at the Fraunhofer facility in Leipzig, Germany. After recuperating
from the surgery, the patient will undergo the blood draw to obtain
his immune cells. During the following weeks, the DCVax-L
manufacturing process and quality control testing will be completed
for that patient. Additional patients who are being assessed
will follow the same course.
This first patient is a German citizen and has already submitted
his application for approval of reimbursement. Discussions
with the Sickness Funds (insurers) about pricing and reimbursement
are ongoing.
"DCVax-L is addressing a serious unmet medical need for new
treatment options for brain cancer," commented Prof. Dr.
Dietmar Krex, senior neurosurgeon at
the Department of Neurosurgery, University Hospital of Dresden,
Germany, and Medical Advisor to NW
Bio's Hospital Exemption program. "The Hospital Exemption for
DCVax-L is a groundbreaking step, giving hope and offering a new
treatment modality to patients with the disastrous diagnosis of a
malignant glial brain tumor. Of course, we are also looking
forward to completing the Phase III trial as soon as possible to
confirm the effectiveness of the DCVax-L treatment."
Linda Powers, CEO of NW Bio
observed, "It is very gratifying to see the DCVax-L Hospital
Exemption program launched and under way with patients. It is
the culmination of more than 4 years of planning, technology
transfer, training, development of manufacturing capacity,
regulatory submissions and reviews, inspections and certifications
at both the Federal and local level in Germany, Ethics Committee approvals, contract
negotiations, patient documentation and procedures, logistical
arrangements and data collection arrangements. We are excited
about the opportunity to provide a much needed new treatment option
for patients, and to practice for commercialization, gradually
ramping up our Hospital Exemption program while we work toward
completing the Phase III clinical trial."
To receive more information on this program, prospective
patients may contact NW Bio at patients@nwbio.com.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on
developing immunotherapy products to treat cancers more effectively
than current treatments, without toxicities of the kind associated
with chemotherapies, and on a cost-effective basis, in both
the United States and
Europe. The Company has a broad platform technology for DCVax
dendritic cell-based vaccines. The Company's lead program is
a 348 patient Phase III trial in newly diagnosed Glioblastoma
multiforme (GBM). GBM is the most aggressive and lethal form
of brain cancer, and is an "orphan disease." The Company is
under way with a 60-patient Phase I/II trial with DCVax-Direct for
all inoperable solid tumors cancers, with a primary efficacy
endpoint of tumor regression. It has completed enrollment in
the Phase I portion of the trial. The Company previously received
clearance from the FDA for a 612-patient Phase III trial in
prostate cancer. The Company conducted a Phase I/II trial
with DCVax for metastatic ovarian cancer together with the
University of Pennsylvania. In
Germany, the Company has also received approval of a 5 year
Hospital Exemption for the treatment of all gliomas (brain cancer)
patients outside the clinical trial.
Disclaimer
Statements made in this news release that are not historical
facts, including statements concerning future treatment of patients
using DCVax and future clinical trials, are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "expect," "believe,"
"intend," "design," "plan," "continue," "may," "will,"
"anticipate," 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 risks related to the Company's ongoing
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, uncertainties about the clinical trials
process, uncertainties about the timely performance of third
parties, risks related to whether the Company's products will
demonstrate safety and efficacy, risks related to the Company's and
Cognate's abilities to carry out the intended manufacturing
expansions contemplated in the Cognate Agreements, risks related to
the Company's ability to carry out the Hospital Exemption program
and risks related to possible reimbursement and pricing.
Additional information on these and other factors, including Risk
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 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.