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[ biotech news ] Independent Data Monitoring Board Holds Third Review of Safety Data
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Independent Data Monitoring Board Holds Third Review of Safety Data
Recommends Satraplatin Phase 3 Registrational Trial Continue as
Planned
IRVINE, Calif., December 13, 2005 -- Spectrum Pharmaceuticals, Inc.
today announced that the independent Data Monitoring Board (DMB) for
the satraplatin Phase 3 registrational trial SPARC (Satraplatin and
Prednisone Against Refractory Cancer) in second-line chemotherapy
for hormone-refractory prostate cancer held its third meeting on
December 12, 2005 to review safety data from the ongoing study. The
Charter of the DMB requires that the group meet at least twice each
year. The DMB reviewed the safety data from the first 592 patients
who had been randomized in the trial and had completed at least one
cycle of treatment. After reviewing the data, the DMB reported that
the design and conduct of the trial remain sound and recommended
that the trial continue as planned. The interim efficacy analysis by
the DMB is expected to occur, as previously stated, by the end of
the first quarter of 2006.
As reported earlier this month, GPC Biotech AG, Spectrum's co-
development partner, has achieved its target accrual of 912 patients
in the SPARC trial.
About Satraplatin
Satraplatin, an investigational drug, is a member of the platinum
family of compounds. Over the past two decades, platinum-based drugs
have become a critical part of modern chemotherapy treatments and
are used to treat a wide variety of cancers. Worldwide sales of
these drugs exceeded $2.2 billion in 2004. Unlike the platinum drugs
currently on the market, all of which require intravenous
administration, satraplatin is an orally bioavailable compound and
is given as capsules that patients can take at home. An oral
platinum drug could offer key advantages, including ease of
administration and patient convenience, in a variety of
applications. The Phase 3 registrational trial -- the SPARC trial --
as a second-line chemotherapy treatment for hormone-refractory
prostate cancer (HRPC) has just reached its target enrollment. The
FDA has also granted fast track designation to satraplatin for this
indication.
Phase 2 trials have been completed in HRPC, ovarian cancer and small-
cell lung cancer. Promising early clinical results have also been
shown when satraplatin is combined with radiation therapy, and a
Phase 1/2 study evaluating this combination in patients with non-
small cell lung cancer has been initiated. Several other Phase 1 and
Phase 2 studies evaluating satraplatin in combination with other
therapies and in various cancers are underway or planned. Further
information on satraplatin can be found at the Company's website at
www.spectrumpharm.com or in the Anticancer Programs section of GPC
Biotech's website at www.gpc-biotech.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a specialty pharmaceutical company
engaged in the business of acquiring, developing and commercializing
prescription drug products for the treatment of cancer and other
unmet medical needs. By leveraging its operational flexibility and
regulatory proficiency, and using the extensive research and
development capabilities of its strategic alliance partners,
Spectrum has built a diversified portfolio of proprietary and
generic drug products in various stages of development and
regulatory approval. For more information, please visit our website
at www.spectrumpharm.com.
Forward-looking statements
This press release may contain forward-looking statements regarding
future events and the future performance of Spectrum Pharmaceuticals
that involve risks and uncertainties that could cause actual results
to differ materially. These statements include but are not limited
to statements that relate to our business and its future, the
Company's operational flexibility and regulatory proficiency, the
extensive research and development capabilities of the Company's
strategic alliance partners, that satraplatin could offer key
advantages, including ease of administration and patient
convenience, in a variety of applications, the initiation of several
other Phase 1 and Phase 2 studies evaluating satraplatin in
combination with other therapies and in various cancers and any
statements that relate to the intent, belief, plans or expectations
of Spectrum or its management, or that are not a statement of
historical fact. Risks that could cause actual results to differ
include the possibility that our existing and new drug candidates,
may not prove safe or effective, the possibility that our existing
and new drug candidates may not receive approval from the FDA, and
other regulatory agencies in a timely manner or at all, the
possibility that our existing and new drug candidates, if approved,
may not be more effective, safer or more cost efficient than
competing drugs, the possibility that past results (including
results related to the safety of the Phase 3 satraplatin trial) will
not be indicative of future results, the possibility that price and
other competitive pressures may make the marketing and sale of our
generic drugs not commercially feasible, the possibility that our
efforts to acquire or in-license and develop additional drug
candidates may fail, our lack of revenues, our limited experience in
establishing strategic alliances, our limited marketing experience,
our limited experience with the generic drug industry, our
dependence on third parties for clinical trials, manufacturing,
distribution and quality control and other risks that are described
in further detail in the Company's reports filed with the Securities
and Exchange Commission.
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