NWBT - really wide awake now.....20/.21 1.7mm sh. on this:
Northwest Biotherapeutics, Inc. to Initiate Phase III Clinical Trial for Prostate Cancer Dendritic Cell-Based DCVax(R)-Prostate Phase III IND Cleared by FDA for Assessment in Non-Metastatic Hormone Independent Prostate Cancer Patients
BOTHELL, Wash., Jan 31, 2005 /PRNewswire-FirstCall via COMTEX/ -- Northwest
Biotherapeutics (OTC Bulletin Board: NWBT.OB) today announced that it has
received clearance from the Food and Drug Administration (FDA) to begin
assessment of its cell based dendritic cell product candidate,
DCVax(R)-Prostate, in a Phase III clinical trial. This trial is based on
promising clinical data from a previously conducted Phase I/II clinical trial.
The double blinded, placebo controlled Phase III clinical trial is expected to
enroll about 600 patients at 30-50 sites throughout the United States.
"The initiation of this Phase III trial for non-metastatic hormone independent
prostate cancer patients represents a major milestone achievement for our lead
product candidate, DCVax(R)-Prostate, and for implementation of our new business
strategy, and progress with our recent recapitalization agreement with Toucan
Capital of Bethesda, MD" stated Alton L. Boynton, Ph.D., President, Chief
Operating Officer, and a co-founder of NWBT. "I believe DCVax(R)-Prostate
represents a promising new treatment for non-metastatic hormone independent
prostate cancer for which there is currently no FDA approved product."
Northwest Biotherapeutics previously received clearance through the FDA for a
Phase II clinical trial for DCVax(R)-Brain, a promising new treatment for
Glioblastoma Multiforme which is the most common, and lethal form of brain
cancer. The company intends to begin this multi-site clinical trial later this
year. In addition, the DCVax(R) platform can be used for multiple cancer
indications, and NWBT has completed preclinical work targeted for a Phase I
clinical trial for non-small cell lung cancer and head and neck cancer.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on discovering,
developing and commercializing immunotherapy products that safely generate and
enhance immune system responses to effectively treat cancer. The company has
completed Phase I/II clinical trials for its lead product candidate DCVax(R) --
Prostate and completed preclinical work for several other product candidates
targeting multiple cancers. Three technologies form the basis of our product
candidates: a dendritic cell-based immunotherapy platform applicable to multiple
cancers; a therapeutic monoclonal antibody product candidate applicable to
multiple cancer types; and an antibody-based imaging agent for metastatic
prostate cancer.
Statements made in this news release that are not historical facts are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. Words such as "expects," "believes," "intends,"
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 the planned Phase III trial of DCVAX(R)-Prostate
and complete the trial on a timely basis, the uncertainty of the clinical trials
process and whether DCVAX(R)-Prostate will demonstrate safety and efficacy,
risks associated with the planned Phase II clinical trial of DCVAX(R)-Brain and
the planned Phase I clinical trial for non-small cell lung cancer and head and
neck cancer, and the timely performance of third parties. Additional information
on these and other factors, which could affect the Company's results, is
included in its Securities and Exchange Commission 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 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.
SOURCE Northwest Biotherapeutics, Inc.
CONTACT: Lorie Calvo of Northwest Biotherapeutics, Inc., +1-425-608-3008, or lcalvo@nwbio.com
URL: prnewswire.com
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