BETHESDA, Md., May 2, 2016 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a U.S. biotechnology
company developing DCVax® personalized immune therapies for solid
tumor cancers, announced today an operations update in regard to
its Phase I and II Trials, Scientific Advisory Board and Nasdaq
compliance.
The Company has reached conceptual agreement with three
different sets of parties, in regard to three different combination
treatments, for three different cancers in three different Phase II
trials. These involve leading participants in the
immunotherapy field. The Company and these parties are now
completing the agreements and budgets, and pursuing regulatory
approval for the agreed upon trials.
The Company is establishing a Scientific Advisory Board
("SAB"). The Company has reached agreement with the initial
members of the SAB, including leading experts in immunotherapy and
oncology from both the US and Europe. The initial members are
in the process of completing their internal institutional
approvals.
The Company has received updated data from the ongoing follow-up
of patients in the Phase I portion of the DCVax-Direct trial.
To date, 20 of the 40 patients have exceeded 12 months overall
survival ("OS"), 13 of the 40 patients exceed 18 months OS, at
least 10 of those 13 patients (with 2 of the 13 currently unknown)
are still alive at OS times up to 29 months to date, with the
majority having exceeded 20 months.
The Company has undertaken extensive analyses of data from the
Phase I portion of the Phase I/II trial of DCVax-Direct for all
types of inoperable solid tumors. The Phase I portion of the
study involved 3 different dose levels, 2 different product
formulations, 13 different cancers, several modes of image guidance
for treatment administration and multiple measures related to
immune system activation. Analyses of this data have found
some novel, unexpected and encouraging results that are of
significance for further trials. Also, the Company and
physician advisors have completed clinical analyses and
preparations for injection of multiple tumors in multiple different
tissue locations (going well beyond what any other known trial has
undertaken), as well as a greater number of treatment cycles, for
the upcoming Phase II portion of the trial. In addition, the
Company and its manufacturer, Cognate BioServices, Inc. ("Cognate")
have completed a lengthy program of development work to further
optimize the DCVax-Direct investigational
product.
The Company's Phase III trial of DCVax-L for GBM brain cancer is
ongoing. As previously announced, well over 300 patients have
been enrolled in the trial and the patients are continuing to be
treated in accordance with the trial protocol. The trial
remains subject to a partial clinical hold on screening of
additional patient candidates. The Company is in ongoing
dialog with regulators, and providing further information.
The Company hopes that this issue will be resolved soon.
The Company has received a letter from the staff of The NASDAQ
Stock Market LLC ("Nasdaq") indicating that the Nasdaq Staff
reviewed certain stock issuances by the Company to Cognate, and
determined that those issuances did not comply with Nasdaq rules
5635(c) and (d), as described in a Form 8-K being filed by the
Company today. The Company is currently in discussions with
the Nasdaq Staff about two potential approaches to remedy the
non-compliance with these rules, and the Company intends to take
the appropriate steps to address the issues raised by the Nasdaq
Staff as quickly as possible.
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 60-patient
Phase I/II trial with DCVax-Direct for all types of inoperable
solid tumors cancers. It has completed enrollment in the
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. The Company previously received
clearance from the FDA for a 612-patient Phase III trial in
prostate cancer. In Germany,
the Company has received approval of a 5-year Hospital Exemption
for the treatment of all gliomas (primary brain cancers) 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 and uncertainties related to the
actions and decisions of Nasdaq and Cognate, 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 including the actions and decisions of the FDA and other
regulators, 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 and
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.