Further Progress Made For DCVax-L Brain Cancer Clinical Trial - Analyst Blog
May 21 2012 - 6:07AM
Zacks
Further Progress Made For DCVax-L Brain Cancer Clinical
Trial
Grant Zeng, CFA
On May 17, 2012, Northwest Biotherapeutics
(NWBO) announced that it already has 41
clinical trial sites open and recruiting across the United States
in its ongoing clinical trial of DCVax-L immune therapy for
Glioblastoma multiforme (GBM), the most lethal form of brain
cancer.
This is ahead of the Company’s previous projection of 40 sites by
the end of Q2, 2012. The Company plans to continue adding
clinical trial sites in the US and Europe, and expects to have at
least 60 sites open and enrolling by the end of Q3, 2012. The
Company plans to have total of 80 sites for the trial.
The Company also announced that the FDA has accepted an amendment
of the clinical trial. The amendment does not make any change in
the treatment regimen, which leaves all data collected to date
intact for use in the trial’s overall results. The amendment
includes the following:
• The previous Phase II trial has been
designation as a Phase III trial;
• Expanded and enhanced statistical endpoint
analyses;
• With the addition of another cohort of patients
which can potentially expand the application of DCVax-L, the trial
size has been increased up to 300 patients from previous 240
patients;
• Addition of interim analyses for efficacy;
As a reminder, the previous Phase II trial of DCVax-L is an ongoing
randomized, placebo controlled, double blinded (2:1) study with a
cross-over arm allowing control patients to be treated with DCVax-L
in the event that their cancer progresses. The primary end point is
progression free survival (PFS) with overall survival (OS) as the
secondary end point. The original 240-patient trial is designed to
enable the Company to petition the FDA for accelerated approval if
the study generates results similar to those achieved in the two
prior Phase I clinical trials.
Our Immediate Takeaways
This announcement is another indication that NWBO is making further
progress in its key program DCVax-L for brain cancer.
The Company has continuously beats its expectations about adding
new clinical trial sites. In addition, the official designation of
the previous Phase II trial of DCVax-L as a Phase III trial makes
DCVax-L one step closer to the market. This is also a further
indication that management is making every effort to make this
breakthrough medicine to brain cancer patients around the world
though the evolution of this trial to a Phase III trial is no
assurance of the outcome.
In order to accelerate the clinical trial and expand it to Europe,
the Company established two partnerships in April. One is with the
Fraunhofer IZI Institute in Germany, and another one is with King's
Health Partners in London, Britain. Both institutions are
prestigious health organizations in Europe. We think the two
partnerships in Germany and Britain are very encouraging news and
positive to NWBO in the following aspects:
• The two partnerships will help accelerate the
Company’s ongoing international Phase II clinical trial of DCVax-L
for GBM (designed and powered as a pivotal trial). Data from
Germany and Britain combined with US clinical sites could form the
basis for the submission of a BLA in the US and EU.
• The compassionate use of DCVax-L will help
extend lives for other patients who are not qualified while the
trials are ongoing. It may also bring some additional revenues for
the Company although it won’t be material in our view.
• The collaborations also expand NWBO’s
manufacturing capacity and flexibility for DCVax® products, without
the need for any capital investment by the Company.
• Overall, the partnerships with King's Health
Partners and the Fraunhofer IZI Institute provide solid foundation
for NWBO's programs in Europe upon which NWBO can proceed with
clinical trials in Europe, and with compassionate use treatments of
patients in parallel with such clinical trials.
With the new announcement about the trial sites update and
amendment to the Phase II trial, the Company’s lead program has
advanced and emerged as 300-patient, international Phase III trial,
involving some of the best institutions in the US, UK and Germany.
The Company plans to petition for product approval in the U.S.
and/or the European Union if the Phase III trial results are
positive. In such a case, DCVax-L could potentially be the second
active immunotherapy for cancer in the US and the first active
immunotherapy for cancer in the EU.
Please visit Grant's coverage page at scr.zacks.com to access a
free copy of the full research report.
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