BETHESDA, Md., March 27, 2015 /PRNewswire/ -- Northwest
Biotherapeutics, Inc. (NASDAQ: NWBO) ("NW Bio"), a
biotechnology company developing DCVax® personalized immune
therapies for cancer, announced today that Dr. Marnix Bosch, the Company's Chief Technical
Officer, presented encouraging survival data on 51 Glioblastoma
multiforme (GBM) brain cancer patients treated with DCVax®-L.
The data showed substantially longer than expected survival in
patients with apparent early progression (recurrence) of their
cancer, including patients with such aggressive cancer that the
tumor was already re-growing by the end of 6 weeks of daily
radiotherapy and chemotherapy after surgical removal of the
original tumor.
As previously announced, Dr. Bosch's presentation was made at
the 2nd Immunotherapy of Cancer (ITOC) Conference in
Munich, Germany, yesterday and was
webcast. The webcast of the presentation, entitled "Prolonged
Survival In Patients With Recurrent GBM Who Are Treated With Tumor
Lysate-Pulsed Autologous Dendritic Cells," can be seen for up to 30
days at http://nwbio.com/webcasts/ The presentation poster
can be found on the Company's website.
The 51 GBM patients were treated in an Information Arm outside
the Company's Phase III clinical trial because they were not
eligible for the trial, due to evidence of early tumor re-growth
following 6 weeks of daily radiotherapy and chemotherapy which are
standard of care. Overall Survival data is available for all
51 patients; however, MRI images are only available for 46 of the
51 patients. These 46 patients were classified by an
independent medical imaging company into 3 groups, as
follows. The other 5 patients remained unclassified, due to
lack of available images.
- 20 Rapid-Progressor Patients: Patients with a new lesion ≥ 1
cm. in size, or tumor growth of ≥25% both at a Baseline Visit and
at Month 2 thereafter;
- 25 Indeterminate Patients: Patients with evidence of
progression at the Baseline Visit (rendering them ineligible for
the trial), followed by stable disease, modest progression and/or
modest regression (or unclear tumor measurements), neither of which
is enough to classify them as either a Rapid-Progressor or a
Pseudo-Progressor;
- 1 Pseudo-Progressor: A patient whose Month 2 image showed
resolution of most of the prior appearance of tumor growth that had
been seen at the Baseline Visit.
The prognosis for Rapid Progressor patients is especially
poor: their median Overall Survival is only about 8 to 10
months, according to published scientific literature, and they
generally are not expected to respond much to any treatments.
There is no established benchmark for Overall Survival of the
Indeterminate Patients, however, they can be compared to the
general population of GBM patients, for whom median Overall
Survival is 14.6 months.
The survival to date, for each of these groups of Information
Arm patients treated with DCVax-L, is as follows:
- Overall: The median OS of the group of
51 Information Arm patients as a whole is 18.3 months. About 30% of
the patients (15 of the 51) lived beyond 2 years, and most of these
patients (12 of the 15) remain alive.
- 20 Rapid-Progressors: The median OS
among these 20 DCVax-L treated patients is 15.3 months (with
patients surviving as long as 37.1 months), compared to expected
median OS of 8.3 - 10.8 months with existing treatments, based on
published literature on comparable patient populations -- a 50%
improvement over the expected survival time. Further, one-third of
these patients (7 of the 20) lived beyond 18 months – a doubling of
the expected survival time with existing treatments.
- 25 Indeterminate Patients: The median
OS among these DCVax-L treated patients is 21.5 months (with
patients surviving as long as 40.7 months), compared to median OS
in the general population of newly diagnosed GBM patients of 14.6
months – a 50% improvement over the expected survival time.
Further, 9 of these 25 patients remain alive today at more than 24
months, 6 of these 9 patients have exceeded 30 months, and 4 of
these 9 patients have reached 35-40+ months.
- 1 Pseudo-Progressor: This patient is
still alive, with OS of 30.1 months to date.
- 5 Unclassified Patients: The median OS
is 9.2 months (with patients surviving as long as 30.1
months).
As reflected in these data, both Rapid-Progressor Patients and
Indeterminate Patients (as well as the Pseudo-Progressor Patient)
treated with DCVax-L in the Company's Information Arm are
surviving substantially longer than would be expected based on
clinical experience reported in the literature.
DCVax-L also continues to show an excellent safety profile, with
no serious adverse events observed in these Information Arm
patients.
"We are quite encouraged to see survival times in our DCVax-L
treated Information Arm patients that exceed the expected survival
times with existing treatments by 50% or more," commented
Linda Powers, CEO of NW Bio.
"This survival data, which has been collected by the independent
CRO managing our Phase III trial, provides an encouraging insight
into the potential results of the DCVax-L treatments for newly
diagnosed patients in the Phase III trial. The survival data
also reinforce the results we have seen with extended survival in
our prior Phase I/II trials, and reinforce NW Bio's position as a
leader in immune therapies for cancer."
Background
The Company treated a total of 55 patients in an "Information
Arm" outside of the Company's ongoing Phase III clinical trial of
DCVax-L for newly diagnosed GBM: 51 of these 55 patients were
not eligible for the trial because they had evidence of early
progression (tumor growth) at a Baseline Visit at the end of 6
weeks of daily radiotherapy and chemotherapy after surgical
resection of their brain tumor; 4 of the patients were not
eligible for the trial for other reasons (e.g., insufficient doses
of DCVax-L).
These Information Arm patients received the same DCVax-L
product, on the same treatment schedule, in the same medical
centers, in the same time period as the Phase III clinical trial,
and the data have been collected and maintained by the same
contract research organization (CRO) managing the Phase III
trial.
As Dr. Bosch described in his conference presentation, as part
of the eligibility assessment for the Phase III clinical trial,
patients underwent MRI imaging at a Baseline Visit at the end of
the 6 weeks of daily radiotherapy and chemotherapy which is
standard of care following the surgical removal of the original
tumor. Patients who already have disease progression (tumor
re-growth) so quickly, and in the midst of such daily treatments,
are generally considered to be "Rapid Progressors." Such
patients are usually excluded or segregated in studies and analyses
because their disease is so accelerated that it is not comparable
to regular GBM patients.
The patients in NW Bio's Information Arm were evaluated through
MRI imaging at the Baseline Visit and at Month 2 thereafter.
All images were reviewed and analyzed by an independent
specialized medical imaging company. Each image was reviewed
separately by two independent reviewers, and any material
differences were resolved by a third independent reviewer.
Reviews were conducted using both RANO and McDonald
criteria.
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 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 tumors cancers, with a primary efficacy
endpoint of tumor regression. 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 received approval of a 5-year Hospital
Exemption for the treatment of all gliomas (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, Inc.