Spectrum Pharmaceuticals Initiates Phase 2 Study of Long-Acting GCSF Drug Candidate, SPI-2012, for the Treatment of Chemotherapy-Induced Neutropenia
In U.S.-based Phase 1 trial, SPI-2012 demonstrated increase of
neutrophil count similar to Neulasta®
(pegfilgrastim) at one-third the dose.
Pending clinical progress and regulatory approval, SPI-2012 will
enter a worldwide market estimated to be over $5 billion.
Spectrum has global rights for SPI-2012 except for Korea, China,
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with
fully integrated commercial and drug development operations with a
primary focus in hematology and oncology, today announced the Company
has initiated a Phase 2 clinical program for SPI-2012 (also referred to
as "LAPS-GCSF"), a drug candidate for the treatment of
chemotherapy-induced neutropenia that utilizes partner Hanmi
Pharmaceutical Company's proprietary LAPSCOVERY™ Technology. This
technology, as shown in preclinical models, permits greater marrow
penetration and retention of G-CSF when compared to naked CSF and avoids
elimination through kidney. In a previous Phase 1 trial in healthy
volunteers SPI-2012 showed increase in neutrophil count similar to
Neulasta® (pegfilgrastim) at one-third the dose.
"We are excited to begin mid-stage clinical studies for a drug candidate
that can become a key component of Spectrum's long-term growth," said
Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and
President of Spectrum Pharmaceuticals. "Chemotherapy-induced neutropenia
constitutes a large global market estimated to be over $5 billion, and
there is preliminary evidence showing SPI-2012 may have advantages over
the comparator regarding the intensity and duration of neutrophil
recovery. We look forward to the continued study of this product
candidate, which we believe has the potential to address continued unmet
medical needs by studying the opportunity to minimize the risks from
chemotherapy induced neutropenia."
Spectrum's phase 2 trial is a multicenter, open label, dose-ranging
study, with a non-inferiority design to compare the effectiveness of
SPI-2012 relative to a fixed and standard dose of pegfilgrastim as a
concurrent active control to each dose of SPI-2012. The primary
objective and endpoint of this study is to assess the effect of test
doses 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.
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). Hanmi's LAPSCOVERY™ (Long
Acting Protein/Peptide Discovery) platform technology can be applied to
various molecules including glycosylated proteins, modified or
artificial peptides with unnatural amino acid sequences. LAPSCOVERY™ can
select the optimal conjugation sites from the proteins or peptides to
minimize the structural hindrance and maximize the pharmacological
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
three oncology drugs ─ FUSILEV® (levoleucovorin) for
Injection in the U.S.; FOLOTYN® (pralatrexate injection),
also marketed in the U.S.; and ZEVALIN® (ibritumomab
tiuxetan) Injection for intravenous use, 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®, and ZEVALIN®
are registered trademarks of Spectrum Pharmaceuticals, Inc and its
affiliates. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals
logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
Neulasta® is a registered trademark of Amgen
© 2013 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
Spectrum Pharmaceuticals, Inc.
Strategic Planning & Investor Relations
Source: Spectrum Pharmaceuticals, Inc.
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