GPC Biotech Today Announced Results of Survival Analysis from the SPARC Trial
31 10월 2007 - 12:35PM
PR Newswire (US)
Overall Survival Results Do Not Achieve Statistical Significance
IRVINE, Calif., Oct. 30 /PRNewswire-FirstCall/ -- Spectrum
Pharmaceuticals, Inc.'s (NASDAQ:SPPI) licensee, GPC Biotech, today
announced that the Phase 3 SPARC trial evaluating satraplatin for
the treatment of hormone-refractory prostate cancer did not meet
its primary efficacy endpoint. "We are indeed disappointed that the
overall survival data for satraplatin did not achieve statistical
significance. Drug development is inherently risky and clinical
studies do sometimes fail for various reasons, which is why we
built Spectrum on a business model based on a diversified portfolio
of several late- and early-stage drug candidates. We are not
dependent on the success or failure of any one drug," said Rajesh
C. Shrotriya, M.D., Chairman, President and Chief Executive Officer
of Spectrum Pharmaceuticals, Inc. "We will continue to aggressively
develop our four late-stage drugs, ISO-Vorin(TM), which has a
January 11th FDA action date; sumatriptan injection, which we will
launch with PAR Pharmaceutical Companies in the second-half of
2008; EOquin(R), which is currently enrolling patients in two Phase
3 trials; and ozarelix, where we are currently working on the
protocol for the pivotal registrational trial. Furthermore, we are
currently planning and/or conducting studies for elsamitrucin,
lucanthone, ortataxel, RenaZorb(TM), SPI-1620 and SPI-205." About
Satraplatin In 2002, Spectrum licensed the global rights to GPC
Biotech (Frankfurt Stock Exchange: GPC; TecDAX index; Nasdaq:
GPCB). GPC Biotech is responsible for all costs associated with the
development and regulatory filings of Satraplatin. GPC Biotech has
license agreements with Pharmion GmbH, a wholly owned subsidiary of
Pharmion Corporation, and Yakult Honsha Co., Ltd. Spectrum licensed
worldwide rights to Satraplatin from Johnson Matthey PLC. About
Spectrum Pharmaceuticals Spectrum Pharmaceuticals acquires,
develops and commercializes a diversified portfolio of oncology
drug candidates that meet critical health challenges for which
there are few other treatment options. The company's pipeline
includes promising early and late-stage drug candidates with unique
formulations and mechanisms of action that address the needs of
seriously ill patients, such as at-home chemotherapy and new
treatment regimens for refractory disease. For more information,
please visit our website at http://www.spectrumpharm.com/.
Forward-looking statement -- 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, Spectrum's ability to
identify, acquire, develop and commercialize its portfolio of drug
candidates, the Company's promising pipeline, the Company's
business model, that we are not dependent on the success or failure
of any one drug, that we will continue to aggressively develop our
four late-stage drugs, ISO-Vorin(TM), which has a January 11th FDA
action date; sumatriptan injection, which we will launch with PAR
Pharmaceutical Companies in the second-half of 2008; EOquin(R),
which is currently enrolling patients in two Phase 3 trials; and
ozarelix, where we are currently working on the protocol for the
pivotal registrational trial, that we are currently planning and/or
conducting studies for elsamitrucin, lucanthone, ortataxel,
RenaZorb(TM), SPI-1620 and SPI-205 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 our efforts to acquire or in- license and
develop additional drug candidates may fail, our lack of revenues,
our limited marketing experience, 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. We do not plan to update any such forward-looking
statements and expressly disclaim any duty to update the
information contained in this press release except as required by
law. COMPANY CONTACTS MEDIA CONTACT Russell Skibsted Susan Neath
SVP & Chief Business Officer Porter Novelli Life Sciences
619-849-6007 Paul Arndt Manager, Investor Relations 949-788-6700
DATASOURCE: Spectrum Pharmaceuticals, Inc. CONTACT: Russell
Skibsted, SVP & Chief Business Officer, or Paul Arndt, Manager,
Investor Relations, +1-949-788-6700, both of Spectrum
Pharmaceuticals, Inc.; or media, Susan Neath of Porter Novelli Life
Sciences, +1-619-849-6007, for Spectrum Pharmaceuticals, Inc. Web
site: http://www.spectrumpharm.com/
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