Northwest Biotherapeutics Inc : Northwest Biotherapeutics and the Fraunhofer Institute for Cell Therapy and Immunology Are Partnering for Clinical Trials and Compassionate Use Cases in Europe
05/18/2011 | 07:05am
Northwest Biotherapeutics (OTCBB:NWBO) announced today that it is
partnering with Fraunhofer for production of DCVax®-L for brain cancer,
for clinical trials and compassionate use cases in Europe. Fraunhofer is
the largest applied research foundation in Europe, with a staff of more
than 18,000 scientists, engineers, business personnel and others
dedicated to practical applications and commercialization of research
results, and with annual operations in excess of ?1.66 billion ($2.3
billion). Fraunhofer is a highly respected leader in many areas of
technology, including cell and immune therapies.
The Fraunhofer Institute for Cell Therapy and Immunology IZI, based in
Leipzig, Germany, has dedicated a substantial portion of its
state-of-the-art manufacturing facilities to the production of DCVax®,
and is assisting NWBT with the applicable regulatory requirements for
both clinical trials and compassionate use cases. The Fraunhofer IZI is
also selecting and initiating connections with leading clinical centers
on behalf of NWBT and its DCVax® products.
This partnering arrangement provides a solid foundation upon which NWBT
can proceed with clinical trials in Europe, and with compassionate use
treatments of patients in parallel with such clinical trials. In
addition, NWBT is eligible for certain grants through the German
government which, if approved, can amount to as much as ?2 to 3 million
($2.8 to 4.2 million).
"Partnering with such a prestigious institution as the Fraunhofer IZI is
both gratifying and exciting," commented Dr. Alton Boynton, CEO of NWBT.
"This partnership can help accelerate the Company's brain cancer
clinical trials program, and also help save lives through compassionate
use treatments for other patients while the trials are ongoing."
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. The Company is developing
dendritic cell-based vaccines. The Company's lead clinical trial is a
240-patient Phase II trial in newly diagnosed Glioblastoma multiforme
("GBM"), the most aggressive and lethal form of brain cancer. The
Company also previously received clearance from the FDA for a
612-patient Phase III trial in prostate cancer, and clearance from the
FDA for Phase I trials in five other cancers. The Company has also
conducted a Phase I/II trial with DCVax® for recurrent metastatic
ovarian cancer. For further information about clinical sites and about
the Company, please visit the Company's web site at www.nwbio.com.
About the Fraunhofer Institute for Cell Therapy and Immunology
The Fraunhofer Institute for Cell Therapy and Immunology IZI is a member
of the Fraunhofer Group for Life Sciences. Its objective is to find
solutions to specific problems at the interfaces between medicine, life
sciences and engineering for partners active in medicine-related
industries and businesses. The Institute's core competencies are to be
found in regenerative medicine, or more precisely in cell-therapeutic
methods of regenerating non-functioning tissue and organs through to the
biological substitution with tissue cultivated in vitro (tissue
engineering). In order for the living organism to accept the tissues
without any difficulty, it is necessary to study cellular and
immunological defense and control mechanisms and take these into account
during process and product development. These core competencies entail a
multiplicity of tasks to be solved by new products and processes. The
Institute works especially closely with hospital institutions,
performing quality tests and clinical studies on their behalf.
Additionally, it also provides assistance in obtaining manufacturing
licenses and certifications. www.izi.fraunhofer.de
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, including Risk Factors
which could affect the Company's results, are included in the Company's
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.
NWBT
Dr. Alton Boynton, 425-503-6351
or
Fraunhofer
Dr.
Gerno Schmiedeknecht, 011-49-341-35536-9705
or
Mr. Jens
Augustin, 011-49-341-35536-9320
© Business Wire 2011
