NW Bio Has Initiated Its DCVax®-Direct Phase I/II Trial For All Solid Tumor
MD Anderson Is The First Site; Other Sites In The US And UK To Follow
BETHESDA, Md., June 13, 2013
BETHESDA, Md., June 13, 2013 /PRNewswire/ --Northwest Biotherapeutics
(NASDAQ: NWBO) (NW Bio), a biotechnology company developing non-toxic DCVax^®
personalized immune therapies for solid tumor cancers, announced today that
its 60-patient Phase I/II clinical trial of DCVax-Direct for all inoperable
solid tumor cancers has been initiated at The University of Texas MD Anderson
Cancer Center in Houston, Texas.
DCVax-Direct offers a potential new treatment option for the many clinical
situations in which patients' tumors are considered inoperable either because
of the location or type of cancer, or because of the spread of multiple
tumors. A large number of patients with lung, colon, pancreatic, liver,
ovarian, melanoma, head and neck, and other cancers such as sarcomas face this
situation today, and it carries a bleak prognosis.
The excellent reputation and broad experience of the clinical trial team at MD
Anderson makes them an ideal choice to initiate this study. It is anticipated
that multiple other leading centers in both the US and UK will be joining as
trial sites as well. Since the Company's announcement of plans for this
trial, NW Bio has received inquiries from both patients and medical centers
across the country seeking to participate.
The trial is expected to enroll groups or "cohorts" of patients with numerous
different types of cancers, including pancreatic, colon, liver, melanoma, and
various other cancers.
The trial is a combined Phase I and II trial. In the Phase I stage, the trial
will test various dose levels of DCVax-Direct. The trial will then proceed
directly into the Phase II stage to test the efficacy of the DCVax-Direct
treatment. The primary endpoint for measurement of efficacy will be tumor
regression (i.e., shrinkage or elimination).
As is standard with Phase I/II trials, this trial will not be blinded – the
clinical results in patients will be seen as the trial progresses.
Accordingly, it is anticipated that early results of the trial may be emerging
throughout the remainder of 2013.
Pre-clinical animal studies showed that injection of partially mature
dendritic cells resulted in eradication of tumors -- both tumors that were
injected with DCVax-Direct and tumors that were not injected (indicating a
systemic immune response). In addition, after the animals' tumors had been
eradicated, when the animals were injected again with tumor cells later on,
tumors failed to develop in these animals (indicating immune memory).
The key to DCVax-Direct is the use of partially matured dendritic cells. These
specially prepared dendritic cells have the ability to pick up tumor antigens
(i.e., tumor biomarkers) from tumor cells inside the tumor after the dendritic
cells are directly injected into the tumor. After picking up the antigens,
these dendritic cells also have the ability to travel to lymph nodes and
mobilize the immune system to attack tumors throughout the body which express
these antigens. NW Bio holds strong patent coverage on both the manufacturing
processes and the use of such partially matured dendritic cells.
"We are very pleased to be teaming up with an institution with the depth,
caliber and reputation of MD Anderson to initiate our highly novel,
first-in-man Phase I/II trial of DCVax-Direct for all inoperable solid tumor
cancers," Linda Powers, CEO of NW Bio noted. "After years of painstaking
development, we could not ask for a better clinical partner to explore the
potential of DCVax-Direct to achieve some tumor regression in patients with
According to the primary investigator, Dr. Vivek Subbiah, MD (Assistant
Professor in the Department of Investigational Cancer Therapeutics, Division
of Cancer Medicine, which is responsible for the institution's early stage
clinical trial programs), "Dendritic cell cancer vaccine therapy is a new and
innovative therapeutic approach in our battle against cancer. Dendritic cell
technologies have been advancing, and prior studies have shown encouraging
results. Patients with inoperable tumors face very bleak prognoses, and have
an urgent need for new treatment options. This innovative first-in-human
study of NW Bio's DCVax-Direct for inoperable tumors in multiple types of
cancer is a crucial step forward for a new approach."
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 312-patient Phase III trial in newly diagnosed
Glioblastoma multiforme (GBM). GBM is 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/II trials in multiple other cancers. The Company also conducted a
Phase I/II trial with DCVax for metastatic ovarian cancer together with the
University of Pennsylvania.
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," "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 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, 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.
SOURCE Northwest Biotherapeutics
Contact: Les Goldman, +1-202-841-7909, email@example.com; Beverly Jedynak,
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