New Treatment for Tumors That Are Considered Inoperable
BETHESDA,
MD (Sharewellnewswire.com) September 20, 2012 - Northwest
Biotherapeutics (OTC.BB: NWBO) (NW Bio), a biotechnology company
developing DCVax® personalized immune therapies for cancer, announced
today that it is in late stage discussions with medical centers in the
U.S. and Europe to proceed with a Phase I/II clinical trial with the
Company’s third major product line, DCVax®-Direct, for all types of
solid tumor cancers (i.e., cancers in any tissues). The Company
previously received FDA approval of the clinical trial.
DCVax®-Direct
offers a potential new treatment option for the wide range of clinical
situations in which patients’ tumors are considered “inoperable”
because the patient has multiple tumors, or their tumor cannot be
completely removed, or the surgery would cause undue damage to the
patient and impair their quality of life. A large number of patients
with a variety of cancer types (including lung, colon, pancreatic,
liver, ovarian, head and neck, and others) are faced with this
situation, because their tumors are already locally advanced or have
begun to metastasize by the time symptoms develop and the patients seek
treatment. For these patients, the outlook today is bleak and survival
remains quite limited.
DCVax®-Direct
is administered by direct injection into a patient’s tumors. It can be
injected into any number of tumors, enabling patients with locally
advanced disease or with metastases to be treated. DCVax®-Direct can
also be injected into tumors in virtually any location in the body: not
only tissues at or near the surface of the body but also, with
ultra-sound guidance, into interior tissues.
The
Phase I/II trial with DCVax®-Direct will treat 36 patients in two
parts. In Part 1, 24 patients with any type of solid tumor cancer will
be treated in groups with escalating dose levels. Then, in Part 2, an
additional 12 patients with any selected cancer will be treated with
the optimal dose.
When
DCVax®-Direct was administered in pre-clinical animal studies, existing
tumors regressed. Importantly, the tumors that regressed included not
only tumors that were injected with DCVax®- Direct but also tumors on
the opposite side of the animal’s body which were not injected,
indicating a systemic immune response. Further, when the animals were
subsequently challenged (i.e., injected) with cancer cells, the animals
did not re-develop cancer, indicating immune memory. Notably, the
Company’s proprietary activation step for the dendritic cells appeared
to be essential for these results.
“This
broad Phase I/II trial, allowing DCVax®-Direct to be used for all solid
tumor cancers, is a very significant development for us and will enable
us to make faster and more efficient clinical progress for multiple
cancers than would usually be the case” commented Linda Powers, CEO of
NW Bio. “Based upon the pre-clinical studies showing regression of
existing tumors, DCVax®-Direct may offer a much needed new treatment
option for patients suffering with inoperable tumors today.”
DCVax®-Direct
is based upon the same platform technology as the Company’s first two
major product lines (DCVax®-L and DCVax®-Prostate). This technology
utilizes the patient’s own dendritic cells – the master cells of the
immune system. Each product line involves two key ingredients: the
dendritic cells (which are activated to mobilize the immune system to
attack the patient’s cancer), and biomarkers of the patient’s tumor
(which identify the targets for the immune system to attack).
For
DCVax®-Direct, the dendritic cells are activated in a special
proprietary manner, to enable them to be directly injected into the
patient’s tumors, and to pick up the biomarkers of the tumors onsite in
the tumor. The “educated” dendritic cells then proceed to mobilize the
immune system to attack any tumors bearing those biomarkers.
DCVax®-Direct
is the Company’s third major product line. The Company’s first product
line, DCVax®-L, is potentially applicable for all solid tumor cancers
in which the tumors can be surgically removed. DCVax®-L is currently in
a 300-patient randomized Phase III clinical trial for Glioblastoma
multiforme brain cancer.
The
Company’s second product line, DCVax-Prostate, is for hormone
independent prostate cancer, and has previously been cleared by the FDA
for a 612-patient randomized Phase III clinical trial. The Company
plans to enter into a partnership in order to proceed with this Phase
III trial program.
For further information about the Company and its programs, please visit the Company’s website atwww.nwbio.com.
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
300-patient Phase III trial in newly diagnosed Glioblastoma multiforme
(GBM). GBM is the most aggressive and lethal brain cancer. The Company
also previously received clearance from the FDA for a 612-patient Phase
III trial in prostate cancer, and clearance from the FDA for Phase I/II
trials in multiple other cancers. The Company has also conducted a
Phase I/II trial with DCVax® for metastatic ovarian cancer.
Disclaimer
Statements
made in this news release that are not historical facts, including
statements concerning future treatment of patients with GBM 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,” "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 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, the uncertainty of the clinical
trials process, uncertainties about the timely performance of third
parties, and whether the Company’s products will demonstrate safety and
efficacy. 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.
###
Contact Info:
Les Goldman
202-841-7909
lgoldman@nwbio.com
Beverly Jedynak - 312-943-1123
http://www.nwbio.com
Northwest Biotherapeutics
Les Goldman
202-841-7909
lgoldman@nwbio.com
Beverly Jedynak - 312-943-1123
http://www.nwbio.com
Northwest Biotherapeutics
