BETHESDA, Md., Sept. 16, 2014 /PRNewswire/ -- Northwest
Biotherapeutics (NASDAQ: NWBO) ("NW Bio"), a biotechnology company
developing DCVax® personalized immune therapies for solid tumor
cancers, announced today that its DCVax-L is the first product to
receive formal designation as a "Promising Innovative Medicine"
(PIM) under the new "Early Access to Medicines Scheme" (EAMS)
launched in the UK in April 2014.
A PIM is the first step in a 2-step process for early access
approval under the EAMS.
The PIM designation for DCVax-L covers all malignant gliomas,
which would include both Glioblastoma multiforme (the most severe
grade) as well as less malignant grades, and would include both
newly diagnosed and recurrent gliomas.
The EAMS is an important new initiative in the UK, launched by
the Medicines and Healthcare Products Regulatory Agency (MHRA, the
FDA of the UK), to lead the way in accelerating patients' access to
innovative new medicines for serious diseases. Information
about the EAMS program can be found on the MHRA website at:
http://www.mhra.gov.uk/Howweregulate/Innovation/EarlyaccesstomedicinesschemeEAMS/index.htm
The first step under the EAMS is MHRA's scientific evaluation of
whether a product candidate meets three criteria for a PIM
designation: (i) the product is for a serious disease or
condition with high unmet medical need; (ii) the product is
likely to offer a major advantage over treatments available
today; and (iii) the potential adverse effects of the product
are outweighed by the potential benefits.
NW Bio's DCVax-L has now become the first product to earn this
PIM certification. There is no expiration on the PIM
certification.
The second step under the EAMS is MHRA's determination of a
Scientific Opinion about the product candidate's benefits and
risks, based on available clinical data. A positive or
negative Scientific Opinion will be judged by the same three
criteria as for the PIM designation, as well as a fourth
criterion: the Company's ability to manufacture the product
to rigorous "GMP" (clinical grade) standards.
If the Scientific Opinion is positive, the product candidate may
then be prescribed by physicians and provided to (and paid for by)
patients before the product is formally licensed and while it is
still in clinical development.
MHRA aims to deliver the Scientific Opinion within 90 days after
a party submits an application for Step 2 of the EAMS process.
In granting the first PIM designation under this new EAMS to
DCVax-L, the UK Department Of Health has stated, "An innovative
cell therapy for cancer has become the first to be certified as
'promising' as part of a new Government scheme aimed at getting new
medicines to patients quicker.
The medicine, which has been developed by US-based
pharmaceutical company Northwest Biotherapeutics Inc. (NW Bio), is
the first drug to be awarded the UK's new Promising Innovative
Medicines (PIM) designation, the initial step in the Early Access
to Medicines Scheme which aims to increase patient access to
unlicensed treatments."
UK Life Sciences Minister George
Freeman noted that "The designation of the PIM is the first,
crucial step in developing cutting-edge medicines sooner, giving
real hope to patients and their families."
Dr. Keyoumars Ashkan, a senior neuro-surgeon at Kings College Hospital in London, and the Principal Investigator for the
clinical trial of DCVax-L in the UK, commented that "Brain cancers
strike patients of all ages, and are rapidly lethal. New
treatment options are urgently needed. DCVax-L offers an
exciting new approach to treating these brain cancers, through
personalized immune therapy. It is encouraging to see this
innovative new product be the first to receive certification as a
Promising Innovative Medicine under the new EAMS."
Linda Powers, CEO of NW Bio,
commented that "We are most grateful to the MHRA and Minister
Freeman for spearheading this new EAMS. It strikes a very
practical balance between clinical benefits and risks, through
careful scientific evaluations, and will be of great help to
doctors and patients in opening up new treatment options."
"In prior Phase I/II clinical trials of DCVax-L for brain
cancer, significant delays in disease progression and significant
extensions of patients' survival have been seen, with virtually no
serious adverse effects," Ms. Powers continued. "We believe
that DCVax-L embodies the combination of innovation and beneficial
balance of clinical benefits and risks that the EAMS is designed to
accelerate. We are excited that DCVax-L has received the
first PIM certification."
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 348-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. It has completed enrollment in
the Phase I portion of the trial. 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 has also received approval of a 5-year
Hospital Exemption for the treatment of all gliomas (brain cancer)
patients outside of 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.
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SOURCE Northwest Biotherapeutics