BETHESDA, Md., June 11, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that, in the ongoing Phase I/II clinical
trial of DCVax-Direct for all types of inoperable solid tumors, all
9 out of 9 patients who have received 4 of the 6 planned injections
are showing tumor cell death, tumor shrinkage, substantial immune
cell accumulation in their tumors and/or stabilization (i.e.,
stopping the progression) of their advanced cancer. In
addition, in 3 of these 9 patients, biopsies now show no live tumor
cells in the injected tumor.
To date, 20 patients (including the 9 referenced above) have
received at least 3 of the 6 total injections, and 13 of these 20
patients are showing tumor cell death, tumor shrinkage, substantial
accumulation of immune cells in the tumors, and/or stabilization of
their disease. The Company plans to report more details when
the patients are further along in the treatment regimen. The
first 3 injections are given in the first 2 weeks of the 32-week
treatment regimen (at Day 0, Day 7 and Day 14).
So far, 9 of the patients have received 4 of the 6 planned
injections, and all 9 of these 9 patients are showing tumor cell
death, tumor shrinkage, substantial accumulation of immune cells in
the tumors, and/or stabilization of the patients' disease.
The 4th injection is administered in week 8 of the
32-week treatment regimen. (The overall treatment regimen
includes 6 injections at Days 0, 7 and 14, and Weeks 8, 16 and
32.)
Also, in a new finding, biopsies taken in 3 of these 9 patients
now show no live tumor cells in the tumor that was injected.
These 3 cases include diverse, advanced and particularly
aggressive cancers: 1 metastatic pancreatic cancer case, 1
metastatic colon cancer case and 1 metastatic sarcoma case.
These patients' tumors show some enlargement on imaging
scans, but the biopsies show that live tumor cells are no longer
detectable and immune cells are now found there. Each of
these 3 patients was treated with the lowest dose level (2 million
cells per treatment).
In these 3 patients, as well as the other patients in the trial,
only one of their tumors has been injected with DCVax-Direct.
The Company plans to inject multiple tumors in its further studies
of DCVax-Direct.
"These early glimpses are indicating an increasingly encouraging
picture – especially the absence of any live tumor cells in 3 of
the patients who have received 4 of the 6 planned injections of
DCVax-Direct," commented Linda
Powers, CEO of NW Bio. "The 4th injection is
still quite early, as it is just 8 weeks into the 32-week treatment
regimen. For patients with such advanced, metastatic,
inoperable cancers, who have failed other existing treatments,
these are exciting findings."
"We are also quite encouraged to see the patients' reactions
growing as the treatments progress," noted Ms. Powers. "As of
the 3rd injection in week 2 of the treatments, we now
have 65% of the patients (13 of 20) showing some positive effects,
and as of the 4th injection in week 8 of the treatments,
we now have 100% of the patients (9 of 9) showing some positive
effects. The patients also report feeling significantly
better."
"Patience will be important as we move through the rest of the
treatment regimen for all 36 patients in the Phase I portion of the
trial, and proceed with the Phase II portion of the trial.
The data may get either better or worse as more data is
collected. However, something interesting and encouraging
seems to be unfolding so far."
This growing body of initial early data is a result of both
imaging scans and biopsies. The 9 patients who have received
4 injections show a range of tumor reactions, from shrinkage to no
growth to some enlargement. However, in all of these
patients, the biopsies show substantial tumor cell death, and in
the cases of enlargement, the biopsies show major infiltration and
accumulation of immune cells in and around the tumors – potential
indications of an immune response to the cancer.
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).
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.
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SOURCE Northwest Biotherapeutics