BETHESDA, Md., Dec. 8, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (Nasdaq: NWBO) ("NW Bio" or the "Company"), a biotechnology company developing DCVax® personalized immune
therapies for solid tumor cancers, today provided an update about the Company's Phase 3 trial of DCVax®-L for Glioblastome
multiforme (GBM) brain cancer (the "Trial"). The Company announced that 331 of the planned 348 patients have been enrolled
in the Trial, and that data "events" have been accumulating towards the endpoints of the Trial.
As noted in the profile of the Trial on www.clinicaltrials.gov, the Company had estimated that the numbers of "events" to reach the main endpoints of the
Trial may be reached in November 2016. Following the end of the month last week, the Company requested updates from the
external parties managing the Trial about the numbers of "events" (i.e., tumor recurrences or deaths). Such updates
typically take a couple of weeks, including quality control checking. The Company hopes to receive this information and be
able to make a further update announcement in approximately the next two weeks. The Company remains blinded in regard to
the Trial data and, as before, will only be receiving such updates on a blinded basis.
Since the summer of last year, the trial has been subject to a partial clinical hold, only on recruitment. As a result
of the partial hold, the Trial has not enrolled the last 17 of the total 348 patients. To date, the regulators have not
agreed to remove the partial hold, but have allowed all of the patients in the Trial to continue being treated in accordance with
the Protocol. The Company is pursuing ongoing dialog with regulators. However, at this point the Company believes that the
potential benefits that could be obtained from enrolling the final 17 patients would not be worth the time it would take, as the
process of re-starting and re-training the sites (including through Institutional Review Board renewals) for further enrollment
would take months, followed by further months for the recruitment itself.
Accordingly, the Company is no longer seeking to enroll the last 17 of the 348 patients. Rather, the Company is focused
on accumulation of the "events" necessary for the Trial endpoints. When sufficient "events" have accumulated, the external
parties managing the Trial will then begin the process of moving toward "data lock" and then analysis of the data, which are
typically each multi-month processes, particularly for large international trials.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products designed 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), which is on a partial clinical hold in regard to new screening of patients.
GBM is the most aggressive and lethal form of brain cancer, and is an "orphan disease." The Company is under way with
a Phase I/II trial with DCVax-Direct for all types of inoperable solid tumor cancers. It has completed enrollment in the
40-patient Phase I portion of the trial. The Company previously conducted a Phase I/II trial with DCVax-L for metastatic
ovarian cancer together with the University of Pennsylvania.
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 the necessary funding for its clinical programs, risks related to the Company's ability to retain the patients
in its clinical trials and complete the trials on a timely basis, risks related to clinical trial data collection, completeness
and quality control, risks related to the partial clinical hold on the Company's Phase 3 trial, risks related to the clinical
trials process, risks related to the timely and effective performance of third parties, including with respect to data
collection, security and analysis, risks related to whether the Company's products will demonstrate safety and efficacy, risks
related to regulatory review and/or acceptance of clinical trial data, 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