BETHESDA, Md., June 1, 2015 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology
company developing DCVax® personalized immune therapies for solid
tumor cancers, over the weekend in Chicago released promising new data on their
Phase I trial of DCVax-Direct for direct injection into all types
of inoperable solid tumors.
The patients enrolled in the trial had late stage cancers, with
an average of three inoperable tumors. The patients had
failed multiple prior therapies and had a poor prognosis.
The trial enrolled 40 patients, and 39 were evaluable. A
conservative treatment regimen was used. Although the
patients had multiple inoperable tumors, only 1 tumor was injected
with DCVax-Direct. The treatments included only 3 injections
in the first 2 weeks (Day 0, 7 and 14), and up to 3 additional
injections spaced months apart thereafter (Weeks 8, 16 and 32),
over a total period of 8 months.
Patients typically received their first injection about 1-1/2
months after recruitment. Four patients are still in the process of
completing the study visits, and data collection is ongoing on all
of the patients.
The trial tested three different dose levels of DCVax-Direct,
two different methods of activating the dendritic cells that
comprise DCVax-Direct, and a dozen different cancers. Findings
to date include encouraging survival data and substantial induction
of immune checkpoint expression (PDL-1).
The webcast and presentation by Dr. Bosch can be found on the
Company's website at nwbo.com/webcast
Findings to date include the following:
- 27 of 39 patients are still alive at up to 18 months after
first injection.
- Patient survival correlates with the method of dendritic cell
activation used. With the preferred method, 18 of 21 patients are
still alive.
- Treatment effects have been observed in diverse cancers,
including lung, breast, colorectal, pancreatic, sarcoma, melanoma,
neuro-endocrine and other cancers.
- Patient survival correlates with the number of DCVax-Direct
injections.
- Patient survival also correlates with stabilization of disease
at Week 8 (4th injection visit). Among patients treated with
the preferred method of dendritic cell activation, 16 of 19
achieved stable disease (i.e., less than 25% increase in tumor size
from baseline) at Week 8.
Findings to date relating to immunological responses include the
following:
- Induction of PDL-1 immune checkpoint expression was seen in 64%
of evaluable patients (14 of 22) following DCVax-Direct treatment.
This suggests that the tumors are putting up defenses against the
immune responses induced by DCVax-Direct, and marks these patients
as potential candidates for treatment with checkpoint inhibitor
therapies.
- An increase in T-cell infiltration into tumors, by functionally
active T-cells, was seen following DCVax-Direct treatment.
- Both local effects (in the injected tumor) and systemic effects
were observed.
Based on the findings from the Phase I trial, the Company plans
to enhance its Phase II trials in several ways, including by:
- Using only the preferred activation method of the DCVax
dendritic cells.
- Injecting multiple inoperable tumors at each treatment visit,
not just one.
- Providing more frequent treatments and a larger total number of
treatments.
The Company plans to pursue Phase II trials in non-small cell
lung cancer and sarcoma, as well as a Phase II trial for multiple
diverse types of cancers similar to the Phase I study. The
Company also plans to expand the trial sites to include countries
beyond the U.S.
"We are quite encouraged to see these results across diverse
types of cancers, in late stage patients with multiple inoperable
tumors who have exhausted other treatment options, and with quite a
conservative DCVax-Direct treatment regimen," commented
Linda Powers, CEO of NW
Bio. "We are looking forward to proceeding with Phase II
trials applying the lessons learned from this informative Phase I
trial."
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
U.S. and Europe. The Company has a
broad platform technology for DCVax® dendritic cell-based
vaccines. The Company's lead program is a 348-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 tumor cancers. It has completed enrollment in the Phase I
portion of the trial. 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 has also
received approval of a 5-year Hospital Exemption for the treatment
of all 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.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/nw-bio-announces-data-to-date-from-dcvax-direct-phase-i-trial-300091593.html
SOURCE Northwest Biotherapeutics, Inc.