SPI-2012, is a Long-Acting GCSF that utilizes a proprietary
platform technology, LAPSCOVERY™, designed to the maximize
pharmacological activity of GCSF with potential advantages relating to
more rapid and potent granulocyte recovery compared to pegylated
Enrollment in this study (N= 156 patients) that was started last
year now has been completed; Spectrum expects to make a Phase 3
Go/No-Go decision before the end of the year.
This is a large commercial opportunity with the worldwide market
for neutropenia treatments totaling over $6 billion. Spectrum has
specialized expertise in the neutropenia market, and worldwide rights
for SPI-2012, except in Korea, China, and Japan.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations and with a
primary focus in Hematology and Oncology, today announced that the key
phase 2 trial of its long-acting granulocyte stimulating factor analog
developed using LAPSCOVERY technology (SPI-2012) has completed its Phase
2 study enrollment; this positions Spectrum for Phase 3 decision making
before year end.
"SPI-2012 is the highest priority drug in our pipeline because of its
unique technology, and its potential to provide a new, long-acting
treatment option for patients with chemotherapy-induced neutropenia,"
said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of
Spectrum Pharmaceuticals. "Pre-clinical and Phase 1 studies have
demonstrated that SPI-2012 may have advantages regarding its potency and
duration of neutrophil recovery compared to pegfilgrastim. After several
years of early stage research, we are now getting closer to evaluating
important mid-stage clinical results from SPI-2012. Based on these
results, we look forward to making a Phase 3 Go/No-Go decision on
SPI-2012 before the end of the year."
Spectrum's Phase 2 trial is a multicenter, dose-ranging study that
evaluates the effectiveness and safety of SPI-2012 relative to a fixed,
standard dose of pegfilgrastim as a concurrent active control. The
primary objective and endpoint of this study is to assess the effect of
SPI-2012 on the mean duration of severe neutropenia during Cycle 1 in
patients with breast cancer who are candidates for adjuvant or
neoadjuvant chemotherapy. Three doses of SPI-2012 were evaluated
compared to pegfilgrastim.
In January 2012, Spectrum entered into a co-development and
commercialization agreement with Hanmi, gaining global rights for
SPI-2012 except Korea, China, and Japan.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company focused on
acquiring, developing, and commercializing drug products, with a primary
focus in oncology and hematology. Spectrum and its affiliates market
four oncology drugs ─ FUSILEV® (levoleucovorin) for Injection in the
U.S.; FOLOTYN® (pralatrexate injection), also marketed in the U.S.;
ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use, for which
the Company has worldwide marketing rights and MARQIBO® (vinCRIStine
sulfate LIPOSOME injection) for intravenous infusion, for which the
Company has worldwide marketing rights. Spectrum's strong track record
in in-licensing and acquiring differentiated drugs, and expertise in
clinical development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase 3
studies. More information on Spectrum is available at www.sppirx.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 are based on management's current beliefs and expectations.
These statements include, but are not limited to, statements that
relate to our business and its future, including certain company
milestones, Spectrum's ability to identify, acquire, develop and
commercialize a broad and diverse pipeline of late-stage clinical and
commercial products, leveraging the expertise of partners and employees
around the world to assist us in the execution of our strategy, 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 applications to
the FDA and other regulatory agencies may not receive approval 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 sustained revenue history, 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.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN® and
MARQIBO® are registered trademarks of Spectrum Pharmaceuticals, Inc and
its affiliates. BELEODAQ™, REDEFINING CANCER CARE™ and the
Spectrum Pharmaceuticals logos are trademarks owned by Spectrum
Pharmaceuticals, Inc. Any other trademarks are the property of
their respective owners.
© 2014 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Vice President, Strategic
Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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