Northwest
Biotherapeutics, Inc. (OTC Bulletin Board: NWBO) (AIM: NWBT; NWBS) ("NWBT")
announced that a Phase I/II clinical trial in at least 30 patients,
using DCVax(R)-L for recurrent ovarian cancer, has begun at The University
of Pennsylvania Center for Research on Early Detection and Cure of Ovarian
Cancer and the Abramson Cancer Center. The first patients have been
enrolled and have undergone initial treatment steps in preparation for
receiving DCVax(R)-L. The trial involves two sequential studies, and
comprises an innovative combination of multiple treatment modalities.
DCVax(R)-L forms the cornerstone of the treatment regimen, and is
complemented by administration of low doses of certain existing approved
drugs to help improve the immune system environment, as well as by adoptive
transfer of patients' DCVax(R)-L primed T cells. The principal
investigators for the trial are Dr. George Coukos and Dr. Sarah Kim, and
the Penn Investigational New Drug ("IND") sponsor is Dr. Carl June. The
funding is being provided by the Ovarian Cancer Vaccine Initiative. (See
below for more information about this Initiative.)
DCVax(R)-L is a personalized immunotherapy for cancer, which is made
from a patient's own dendritic cells (the master cells which initiate and
manage the overall immune system response to a disease), and the "antigens"
(biomarkers) from the patient's own tumor tissue which has been surgically
removed as part of the standard of care. Such immunotherapy is sometimes
referred to as a "therapeutic vaccine," as it is designed not to prevent
cancer but to treat patients who already have cancer.
In the first study being conducted by NWBT and Penn, patients will
first undergo standard surgery to reduce their tumor burden. Patients will
then receive limited doses of two existing drugs to improve the immune
system environment and modify the tumor vasculature. Cancer researchers
have become increasingly focused on the role of tumor vasculature and the
tumor microenvironment, as well as the possible role of a certain kind of
cells called "regulatory T cells," in causing a patient's immune system to
become unresponsive to the patient's tumor, and on the potential importance
of modifying these factors in order to achieve robust and durable immune
responses against tumors.
Following the preparatory treatments, the patients in this ovarian
cancer trial will receive a series of three immunizations with DCVax(R)-L,
each two weeks apart, while continuing to receive the low doses of two
drugs intended to keep the immune system and the tumor microenvironment in
a beneficial condition.
The second study, which will be a follow-on to the first study but
covered by a separate IND filing, will compare two treatment arms
continuing further with the drug and DCVax(R)-L regimen, and adding the
adoptive transfer of DCVax(R)-L primed, and expanded T cells.
By combining multiple diverse treatment modalities, structured around
DCVax(R)-L as the cornerstone, this clinical trial is designed to implement
evolving research findings on the complex interactions between tumors and
the "host" tissues in patients, and evolving findings on the many facets of
the immune system and what may be required for effective anti-tumor
responses.
The trial is also designed to minimize any potential toxicity for
patients. Clinical trial experience to date with DCVax(R)-L products in
over 100 treatment cycles in brain cancer patients has shown no toxicity
from the DCVax(R)-L treatment (no grade 3 or 4 adverse events). This
multi-modal ovarian cancer trial has been designed to maintain this
minimal-toxicity approach, by using only low doses of the two drugs
complementing DCVax(R)-L for preparatory effects.
The first patients have been enrolled in the study by Dr. George
Coukos. Dr. Coukos stated, "this is a very significant event for patients
at the University of Pennsylvania and nationwide who are diagnosed with
ovarian cancer. We are excited to work with Northwest Biotherapeutics on
this cutting edge clinical trial, and to test the DCVax(R) platform on an
additional cancer that carries a poor prognosis."
Dr. Carl June, the Penn sponsor on the trial, stated, "the combination
of DCVax(R)-L for ovarian cancer with adoptive immunotherapy using T cells
primed by DCVax(R)-L is an innovative approach that deserves testing in
clinical trials."
"We are very pleased to add Ovarian cancer to the DCVax(R) platform,
and to have Dr. George Coukos and Dr. Carl June lead this effort as the
principal investigators for this clinical trial," stated Alton Boynton,
President and Chief Executive Officer of Northwest Biotherapeutics. "Drs.
Coukos and June are world renowned experts in immunotherapy and in ovarian
cancer. They are playing a major role in the pioneering of novel cancer
treatment strategies -- particularly by combining multiple different
therapeutic approaches."
Ovarian cancer is the fourth leading cause of cancer death among women
in the U.S. Approximately 22,400 new cases were diagnosed in the U.S. in
2006, and about 15,300 deaths occurred. In the majority of ovarian cancer
cases, the disease has already reached late stage, and spread beyond the
ovaries, before it is detected and diagnosed. After initial surgical
removal of tumors, and treatment with currently available drugs, the median
time to disease recurrence is 18 to 20 months. Recurrent disease is
considered incurable and usually results in death, even with aggressive
chemotherapy treatments. Accordingly, there is a major unmet medical need
for new and more effective treatments for ovarian cancer -- especially
recurrent ovarian cancer.
The DCVax(R) platform uses a patient's own tumor, surgically removed as
part of the standard of care, to prepare a mix of their personal cancer
biomarkers. These personal cancer biomarkers are then loaded onto the
patient's own dendritic cells (the master cells responsible for starting
and managing the body's overall immune response), and injected back into
the patient through a simple intra-dermal injection, similar to an insulin
shot, at various intervals over a period of up to three years.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a 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: dendritic cell-based vaccines,
and therapeutic antibodies. The Company is currently conducting a large
clinical trial in Glioblastoma multiforme, which is designed and powered to
serve as a pivotal trial. The Company has also received clearance from the
FDA for a large Phase III trial in prostate cancer, and clearance from the
FDA for Phase I trials in five other cancers. The Company also has a second
technology platform, involving monoclonal antibodies to CXCR4, which is at
the late pre-clinical development stage.
For further information, please visit the company web site at
nwbio.
About the Ovarian Cancer Vaccine Initiative
The Ovarian Cancer Vaccine Initiative (OCVI) is a private philanthropic
organization that is funding this NWBT trial at the Hospital of the
University of Pennsylvania. Fundraising to underwrite the clinical trial,
and translational research that supports it, is actively sought by the OCVI
campaign heads and lead donors, Patricia Dunn and Randall Caudill.
Donations in cash or stock, which qualify for tax-exemption, may be
directed to:
About the Center for Research on Early Detection and Cure of Ovarian
Cancer at the University of Pennsylvania
The Center for Research on Early Detection and Cure of Ovarian Cancer,
directed by Dr. George Coukos, is a newly founded Research Center at the
University of Pennsylvania. The Center comprises several full time
translational and clinical scientists whose focus is to identify new
detection methods, develop new therapies, and ultimately prolong and
improve the quality of life for women with ovarian cancer.
Recent discoveries at the Center include the beneficial impact of
immune response in advanced ovarian cancer; the contribution of
inflammatory cells to the tumor vasculature; the role of tumor vasculature
and tumor microenvironment in controlling the outcome of antitumor immune
response and immune therapy; the identification of novel proteins expressed
in ovarian cancer vasculature that can be targeted for early detection and
therapy; and the identification of several gene alterations in ovarian
cancer including miRNA genes.
The clinical research activities of the Center focus on developing
individualized therapy approaches to patients with ovarian cancer,
combining surgery and conventional therapy with novel immune therapies. A
number of novel immune cellular therapeutic tools are under development in
collaboration with the Cell and Vaccine Production Facility at the Abramson
Cancer Center, directed by Drs. Carl June and Bruce Levine.
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 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, whether the Company's products 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.
Northwest Biotherapeutics, Inc.
nwbio