NW Bio Provides Guidance On Phase III Trial Enrollment Timing: Completion
Expected To Be Faster Or More Efficient Than Relevant Comparison Trials
BETHESDA, Md., March 7, 2013
BETHESDA, Md., March 7, 2013 /PRNewswire/ -- Northwest Biotherapeutics
(NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax^®
personalized immune therapies for solid tumor cancers, announced today that it
expects to complete enrollment in its 312-patient Phase III clinical trial for
Glioblastoma multiforme (GBM) brain cancer within a period that is faster or
more efficient than relevant comparison trials with immune therapies for the
same brain cancer. The Company anticipates completing enrollment of its Phase
III trial by Q1 or early Q2 of next year, and expects to reach its first
interim analysis for efficacy by approximately Q3 of this year.
Relevant comparisons include the following (according to information publicly
reported on www.clinicaltrials.gov and in company announcements and filings):
oCelldex Therapeutics (NASDAQ: CLDX) is conducting a Phase III trial with
440 patients, at 164 clinical trial sites worldwide, which began enrolling
in November 2011, and appears likely to continue enrolling over at least a
4-year period through the end of 2015, with topline results expected at
the end of 2016.
oImmunocellular Therapeutics (NYSE MKT: IMUC) is conducting a Phase II
trial with 124 patients, which were enrolled over the course of 7 calendar
quarters from Q1 2011 through Q3 2012. (IMUC apparently screened 278
patients, but actually enrolled and treated less than half of them: only
124 patients were enrolled, in aggregate, and treated in either the
treatment arm or the placebo arm of the trial.)
oAgenus, Inc. (NASDAQ: AGEN) is conducting a Phase II trial with 55
patients, which began recruiting in Q2, 2009 and stopped recruiting in Q2,
NW Bio has primarily been enrolling its Phase III trial since Q2 of 2011. The
Company undertook a limited period of enrollment in 2008, and then kept the
trial going with the patients already enrolled, but suspended new enrollment
due to resource constraints during the worst of the economic downturn, through
the end of 2010. The Company began the process of reactivating clinical trial
sites for new enrollment in Q1 2011, and resumed screening in Q2 of 2011.
NW Bio expects to complete enrollment in its phase III trial by Q1 or early Q2
of next year – an overall enrollment period of 14 or 15 calendar quarters,
including both the 2008 period and the period since Q2 2011.
This represents a rate of enrollment that compares as follows with Celldex,
IMUC and Agenus:
Pace of Enrollment to
Total Trial Enrollment
Completion, Based On
NW Bio 14 quarters or 22.3 patients per quarter or
Ph. III 15 quarters 20.8 patients per quarter
124 patients 7 quarters 17.7 patients per quarter
27.5 patients per quarter*
440 patients ≥16 quarters [est.]
*[164 clinical trial sites worldwide]
55 patients 12 quarters 4.6 patients per quarter
Notably, even if the completion of NW Bio's Phase III trial enrollment were to
take substantially longer than the Company's projection of Q1 or early Q2
2014, the Company's enrollment would still compare favorably with these
relevant comparison trials.
"There has been widespread confusion in the investment community about the
size and pace of clinical trials being conducted with various immune therapies
for brain cancer," commented Linda F. Powers, CEO of NW Bio. "It is basic to
clinical trials that the sponsor must screen more patients than they enroll.
Normally, there is no confusion about the fundamental difference between
these: 'enrollment' means only the patients actually being treated (with drug
or placebo) in the trial. This is a key metric for investors: it is the
measure of the size and the pace of a trial. By providing detailed
information here, our intention is to help correct the misunderstandings about
the actual enrollment (both size and pace) of certain immune therapy trials in
The Company plans to provide periodic updates of this enrollment guidance
through various communication channels.
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 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 has 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, firstname.lastname@example.org, or Beverly Jedynak,
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