BETHESDA, Md., March 28, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, today refuted false and misleading claims by Adam Feuerstein in an article posted
Thursday, March 27, after NW Bio's
public presentation of significant positive news about all of the
Company's programs.
Feuerstein's headline falsely claims that NW Bio's CEO,
Linda Powers, "disclosed problems"
with the Company's Phase III clinical trial. On the contrary,
Ms. Powers announced entirely positive news about the Company's
Phase III trial as well as its other programs, and Ms. Powers
emphasized in her presentation that prior claims by a commentator
(i.e., Feuerstein) that there were problems with the Company's
Phase III trial were unfounded and wrong. Ms. Powers
reiterated that the Phase III trial is progressing well, and
further centers of excellence are joining the trial.
The Company urges investors, analysts and other interested
parties to view Ms. Powers' presentation (which is available via
webex on the Company's website) to hear the correct, positive
information and form their own opinions.
Feuerstein makes a series of false and misleading claims in his
article. First, Feuerstein describes the Company's Phase III
trial as "requiring a p value of 0.02 to reach statistical
significance" and claims that this makes it more difficult for this
trial to succeed. Feuerstein is factually wrong on both
points: the Company's trial does not "require" a p value of
0.02 to reach statistical significance, and the Company's trial
design increases, not decreases, the trial's ability to
succeed.
The Company's Phase III trial, like all other trials, will be
considered to reach statistical significance if it reaches a p
value of 0.05. "P value" is a measure of the probability that
trial results were due to chance, and not the result of the
experimental treatment being tested. So, the lower the p
value, the better it is. The p value generally required by
regulators for statistical significance is 0.05.
The Company has created a significant cushion or
buffer for achieving this p value of 0.05 by designing its trial to
a level of 0.02 rather than designing to the exact 0.05
level. Having this cushion makes the Company's trial design
more likely for the trial to succeed, not less likely
as Feuerstein claims. If the trial were designed to aim just
for a p value of 0.05 (as Feuerstein tries to argue would be
better), there would be no cushion at all, the risk would be
correspondingly higher, and it would be more difficult for the
trial to achieve success.
A second false claim by Feuerstein in his article is a "guess"
that the Company's Phase III trial has been "poorly run" and that
the trial data "have been looked at some [sic] many times
already that the 'alpha spend' has been gobbled up" -- meaning that
unblinded reviews of the data have used up some of the statistical
cushion. Feuerstein's "guess" is utterly baseless and is
factually wrong again. There has been no such "alpha spend"
to date. Further, the interim analyses in the Company's Phase
III trial are structured so that there will never be large amounts
of "alpha spend" in this trial.
Feuerstein further tries to claim that the Company's trial could
originally have been considered statistically significant with a p
value of 0.05 but somehow must now meet a totally different
standard and reach a p value of 0.02 in order to be considered
statistically significant. Once again, Feuerstein's claim is
baseless and wrong. There has been no such change: the
Company's trial design and target p value are the same now as they
have been throughout the trial. The Company has consistently
reported throughout the trial that it is designed to the 0.02
level. That is a major strength and an intentional trial
design, as already explained – not a weakness or the result of
problems, as Feuerstein falsely asserts.
A third false claim by Feuerstein in his article is that if the
Company makes a choice to increase the number of patients in the
Phase III trial, the Company "will do so out of concern that the
original enrollment figure (312 patients) is too small to produce
a positive result," and that for the Company to exercise this
choice (or even to have the possibility for this choice built into
the Company's trial design) is something negative. Once
again, Feuerstein is factually wrong. If the Company
exercises its choice, the Company will be doing so on an entirely
blinded basis. The Company will have no access to any
accumulated trial data, and will not be acting out of such alleged
"concern."
As Ms. Powers conveyed in her March
27 presentation (and prior presentations), the key to
successful trials and regulatory approvals is strongly powered
trial results. The Company has shaped it Phase III trial
design in order to provide strong powering, reduce risks, and
provide cushions. An increase in patient numbers is simply
another way to enhance the cushion relating to the p value – and
thereby further reduce risks and make it easier for the trial to
succeed.
"We can only conclude that Feuerstein and those with whom he is
allied are disturbed by NW Bio's continued and increasing strong
progress in all of its programs," commented Linda Powers, CEO of NW Bio. "We note that
his attacks seem to regularly coincide with positive NW Bio news
and with substantial short seller activity. Perhaps they are
all just coincidences."
"Feuerstein's long history of false and unfounded attacks on NW
Bio is directly contrary to the major validations we have received
and continue to receive from leading medical institutions, and the
most demanding regulatory agencies and health care
authorities. We encourage investors, analysts and other
interested parties to take a close look at these validations,
compare them to Feuerstein's ongoing attacks, and form their own
opinions about whom to believe."
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, with a primary efficacy
endpoint of tumor regression. 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.
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 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.
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SOURCE Northwest Biotherapeutics