BETHESDA, Md., June 10, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that it has initiated the Phase III trial
of DCVax-L in Germany. The first site to open in Germany was a medical center in Dresden, which
was initiated in late May. The Company has now scheduled the
full-day site initiations for 3 more sites during June and 4
further sites in July.
To date, the trial has been enrolling in parallel in the US and
Europe (in the UK), as previously
announced. The first German site is now starting to screen
patients for purposes of enrollment, and the additional German
sites will begin doing so following their scheduled initiations
(patients can obtain information about trial sites by contacting
the Company at patients@nwbio.com ).
The process of initiating a clinical trial site (i.e.,
completing the steps required to enable a site to participate in,
and to open enrollment for, a clinical trial) typically takes about
6 months for each site in the US. In Germany, there are several further steps
involved beyond those in the US. The process can be conducted
at multiple clinical trial sites (i.e., medical centers) in
parallel, but the steps at each individual site must be done
sequentially.
In the US, the steps required to initiate a site include the
following.
- The first step is the "site qualification," in which both
paperwork and onsite evaluations are done (of personnel,
facilities, past clinical trial experience of both the institution
and the personnel, etc.) to determine the capabilities of the
medical center to serve as a site in the clinical trial. This
step can take a month to arrange and complete.
- The second step is the review and approval of the clinical
trial and all related documents (specific patient consent forms,
data collection, etc.) by that medical center's "Institutional
Review Board (IRB)." In many medical centers, the IRB only
meets once per month. The clinical trial package must be
submitted weeks in advance, and the IRB review, questions, further
submissions, further IRB review and decision typically take 2-3
months.
- The third step is the negotiation of a business contract
("Clinical Trial Agreement") with the medical center's legal
department and clinical trial budget with the medical center's
budget department. The contract terms and budgets can vary
substantially among medical centers within the same clinical trial.
This process typically takes about 2 months.
- The fourth step is the "Site Initiation." This involves
arranging and conducting a full-day, detailed, joint training of
all of the personnel who will be involved in the trial: e.g.,
the neurosurgeons, neuro-oncologists, head of the hospital's
pharmacy, pathologists, radiologists, nurses and others. The
lead time for arranging this joint training with so many players on
the same day is typically substantial. The training includes
all aspects of the trial, including the patient eligibility
criteria and procedures, treatment procedures, testing and
monitoring procedures, data collection, etc.
Each of the above steps must be successfully completed before
the next step at a site can be undertaken (because the sites will
not proceed otherwise), and all of the steps must be successfully
completed before a clinical trial can open for enrollment at that
site. This lengthy process must be accomplished at each site
individually for every site that participates in a clinical
trial.
In Germany, for the DCVax-L
clinical trial, significant additional steps must be completed in
addition to the steps for US sites described above.
- Each clinical trial site must obtain a regulatory license for
tumor tissue collection and use from the local regulatory
authorities in the jurisdiction where the trial site (i.e., medical
center) is located. The requirements of the local regulators
for these licenses vary. The preparation of the appropriate
application package for the local regulators, and the review,
decision and issuance of the tumor collection licenses by those
regulators, takes a couple of months.
- Similarly, each clinical trial site must obtain a regulatory
license for the leukapheresis blood draw (to collect the immune
cells) from the local regulatory authorities in the jurisdiction
where the trial site is located. The local regulators with
the authority over leukapheresis licenses can be different than the
local regulators with authority over licenses for tumor tissue
collection. The preparation of the appropriate application
package for the local regulators, and the review, decision and
issuance of the leukapheresis collection licenses by those
regulators, takes a couple of months. Fortunately, unlike the
other steps involved in clinical trial site initiation, the tumor
collection license and leukapheresis license can proceed in
parallel, so that these two licenses can potentially be completed
simultaneously within a couple of months.
- At many clinical trial sites in Germany, multiple separate business contracts
must be negotiated. Separate contracts must be negotiated
with the radiology department and with the leukapheresis
department, in addition to the Clinical Trial Agreement described
above. The requirements and terms for these additional
contracts vary from site to site, and must be negotiated
individually.
As noted above, in Germany
these steps are in addition to the steps described above which take
about 6 months to enable sites to open for a trial in the US.
Accordingly, the process is somewhat longer in Germany.
"We are excited to have the Phase III DCVax-L trial open for
enrollment in Germany," commented
Linda Powers, CEO of NW Bio.
"It has taken a major team effort to accomplish the steps required
for these sites. However, we are now ready to initiate a
substantial set of clinical trial sites throughout Germany, and we have built a strong foundation
for our clinical programs in Germany."
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.
www.nwbio.com
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SOURCE Northwest Biotherapeutics