Spectrum Pharmaceuticals Highlights Preclinical Data of ROLONTIS™ (eflapegrastim) at the American Association for Cancer R...
04 April 2017 - 9:00PM
Business Wire
- ROLONTIS is currently in a pivotal
clinical development program and is on track for Spectrum to file
BLA next year.
- Eflapegrastim was more potent than
pegfilgrastim at G-CSF equivalent doses in this neutropenic rat
model.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in Hematology and Oncology,
announced the presentation of preclinical data of ROLONTIS from a
poster presentation session at the American Association for Cancer
Research (AACR) Annual Meeting.
“We are excited to see positive data continuing to develop in
our highest priority program,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
“The data shows that in this preclinical study eflapegrastim was
found to be more potent in shortening the duration of severe
neutropenia. Eflapegrastim was more potent than pegfilgrastim at
G-CSF equivalent doses in neutropenic animal models. We are
currently enrolling patients in our pivotal trial and continue to
expect a BLA filing next year.”
Abstract #1347: In vivo efficacy of eflapegrastim in
rats with chemotherapy-induced neutropenia
In this study, rats were treated with 50 mg/kg of
cyclophosphamide (CPA) intraperitoneally to induce neutropenia.
Pegfilgrastim was administered subcutaneously as a single dose of
100 µg/kg on Day 1 and filgrastim was administered subcutaneously
at a dose of 20 µg/kg daily for five days on Days 1 to 5.
Eflapegrastim was administered subcutaneously as a single dose on
Day 1, at doses ranging from 32 µg /kg to 322 µg/kg (or 8.8 µg/kg
to 88 µg/kg as G-CSF equivalent). Blood samples were collected for
8 days after drug administration for the measurement of neutrophil
counts and the Duration of Severe Neutropenia (DSN).
Results showed the DSN in neutropenic rats treated with
eflapegrastim was compared with the DSN in neutropenic rats treated
with pegfilgrastim or filgrastim. The DSN was 0.2 days when
eflapegrastim was administered as a single dose at 88 µg/kg (as
G-CSF equivalent) 24 hours after administering CPA. In contrast,
the DSN was 3.04 days with filgrastim administered at a dose of 20
µg/kg for 5 days from Day 1 to Day 5 and 2.8 days with
pegfilgrastim administered as a single dose of 100 µg/kg 24 hours
after administering CPA. At the lowest eflapegrastim dose of 8.8
µg/kg that was about 1/10 of G-CSF equivalent dose for
pegfilgrastim, the DSN in eflapegrastim-treated rats was 2.94 days.
Thus, eflapegrastim was found to be more potent in shortening the
DSN with a lower G-CSF equivalent dose when compared to either
pegfilgrastim or filgrastim.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in Hematology and Oncology. Spectrum
currently markets six hematology/oncology drugs, and has an
advanced stage pipeline that has the potential to transform
the Company. Spectrum's strong track record for 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 Spectrum’s 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, the timing
and results of FDA decisions, 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 Spectrum’s 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 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. The Company does not plan to update any such
forward-looking statements and expressly disclaims any duty to
update the information contained in this press release except as
required by law.
SPECTRUM PHARMACEUTICALS, INC. is a registered trademark of
Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING
CANCER CARE™, and ROLONTIS™ and the Spectrum Pharmaceuticals' logos
are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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