BETHESDA, Md., May 27, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, today provided a summary of initial data to date in its
ongoing Phase I/II clinical trial of DCVax-Direct for all types of
inoperable solid tumors. The Company reported that over 50%
of the patients who have completed at least half of the 6
treatments in the trial are already showing preliminary signs of
cancer cell death, tumor shrinkage and/or stabilization (i.e.,
stopping the progression) of their advanced cancer.
Further information will be available at the Company's exhibit
booth at the upcoming ASCO conference. The Company also plans
to conduct a conference call to discuss the initial preliminary
data.
The Company's Phase I/II trial of DCVax-Direct is treating
patients with advanced, inoperable cancers involving multiple
metastases (including metastatic colon cancer, pancreatic cancer,
sarcoma, melanoma and others). Although these patients have
such advanced metastatic disease, only one tumor is being injected
in each patient because the current trial is a first-in-man
study. In future studies, the Company plans to inject
DCVax-Direct into multiple tumors in each patient.
The Phase I portion of the trial includes 36 patients. To
date, 19 patients have completed at least half of the 6 treatments
with DCVax-Direct, which are spread over 8 months. None have
yet completed all 6 treatments.
Among the 19 patients who have received at least half of the 6
treatments, 11 patients have already shown some preliminary
positive responses to the treatments, including the following:
- 8 of the 11 patients have shown signs of tumor necrosis (cell
death) and immune cell infiltration, as well as stabilized disease
that has stopped progressing, following the injections of
DCVax-Direct.
- For all of these 8 patients, biopsies indicated substantial to
extensive tumor necrosis, as well as substantial accumulations of
immune cells infiltrating into and around the patients' tumors,
following the DCVax-Direct injections.
- For 6 of these 8 patients, imaging scans also indicated either
tumor shrinkage or no disease progression following the
DCVax-Direct injections.
- For the other 2 of these 8 patients, imaging scans seemed to
indicate some enlargement of their tumors. However, the
needle biopsies revealed that the tumor was filled with necrosis
(dead tumor cells) and infiltrating immune cells, as noted above.
In addition, these patients have reported significant
improvement in their physical condition and clinical symptoms.
- The other 3 of the 11 patients have shown stabilized disease,
with no growth in their advanced and aggressive tumors following
the DCVax-Direct injections, but have not yet shown definitive
necrosis or infiltration of immune cells into their
tumors.
Among the remaining 8 of the 19 patients who have received at
least half of the 6 injections in the trial:
- 1 of these 8 patients requires more data before a preliminary
assessment can be made;
- 7 of these patients have shown progression of their
disease.
The Phase I/II DCVax-Direct clinical trial includes a total of
60 patients: 36 in the Phase I portion and 24 in the Phase II
portion. The DCVax-Direct trial began treating its first
patients in Q3 of last year.
As is often the case with first-in-man studies, the Company's
DCVax-Direct trial was required, as a regulatory matter, to proceed
slowly until safety considerations could be assessed. The
Company was required to treat just one patient with at least 2 of
the 6 treatments in the overall regimen, then wait 2-3 weeks before
treating the next single patient in the same way, and so on,
treating just one patient at a time.
By March, the Company was permitted to begin enrolling without
such pacing limitations. In the period between March and May,
most of the remaining slots in the 36-patient Phase I trial have
been enrolled or completed screening. (Enrollment occurs
after both the screening and the product manufacturing have been
completed for that patient.)
The DCVax-Direct treatment regimen in the clinical trial
includes a total of 6 injections: initially at Day 0, Day 7
and Day 14, followed by injections at Week 8, Week 16 and Week
32.
"We are excited to already begin seeing some initial positive
responses in such a substantial percentage of the DCVax-Direct
patients," commented Linda Powers,
CEO of NW Bio. "We had anticipated potentially seeing responses
within a couple of months after treatment, but seeing such
responses while these patients are still only part way through
their treatment is especially encouraging."
"It is also exciting to see these initial responses in diverse
cancer types, and in patients with very advanced, inoperable
metastatic cancers – especially with only one tumor being injected
with DCVax-Direct in the current trial," Ms. Powers
continued. "Of course, we must emphasize that it is still
early in the DCVax-Direct trial, and the results may become greater
or lesser as more data is obtained. However, there are no
effective treatments for these metastatic cancer patients today,
and we hope that DCVax-Direct will be able to offer an important
new treatment option for these patients."
Dr. Marnix Bosch, Chief Technical
Officer of NW Bio, noted, "As a drug developer and a scientist, it
is exciting to see this early DCVax-Direct progress indicating the
induction of anti-tumor immune responses. We are eagerly
looking forward to seeing the ongoing data."
DCVax-Direct is a personalized immune therapy for all types of
inoperable solid tumor cancers, using dendritic cells (the master
cells of the immune system) to mobilize the full immune system to
attack the patient's cancer. DCVax-Direct is administered by
direct injection into the patient's tumors, and can reach tumors in
virtually any location in the body (with image guidance for
interior locations).
Further information about DCVax-Direct and the Phase I/II
clinical trial will be available at the Company's exhibit booth at
the upcoming ASCO conference, and Company personnel will be
available to discuss this information. In addition, the
Company will be presenting a poster describing the DCVax-Direct
clinical trial. The Company encourages anyone attending ASCO
to visit the Company's exhibit booth.
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, 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. 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 recently
received approval of a 5-year Hospital Exemption for treatment of
glioma (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.
Logo -
http://photos.prnewswire.com/prnh/20110329/SF73084LOGO
SOURCE Northwest Biotherapeutics