-
Poziotinib has shown a remarkable 60% response rate in Phase 1
patients with breast cancer who had previously failed multiple lines
of treatment, including the HER2-directed therapies
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Poziotinib is currently being studied in Phase 2 study in patients
with breast cancer who had previously treated with at least two HER-2
based regimens and Taxane based chemotherapy in Korea
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Spectrum has worldwide rights, excluding Korea and 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, announced today that the
Company has initiated the planned Phase 2 clinical study for Poziotinib,
its novel pan-HER inhibitor. The Phase 2 trial is an open-label study
that will enroll approximately 70 patients with HER2-positive metastatic
breast cancer, who have failed at least two prior HER2-directed
therapies.
"We believe Poziotinib has the potential to be the best in class pan-HER
inhibitor," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive
Officer of Spectrum Pharmaceuticals. "The U.S. Phase 2 trial was
designed on learnings from Hanmi's Phase 1 studies as well as the
ongoing Phase 2 breast cancer trial in Korea. The target market for
HER2-positive agents is large, and we are encouraged by early data
showing that Poziotinib could potentially be another treatment option
for patients."
Poziotinib is a novel, oral pan-HER inhibitor that irreversibly blocks
signaling through the Epidermal Growth Factor Receptor (EGFR, HER)
Family of tyrosine-kinase receptors, including HER1 (erbB1; EGFR), HER2
(erbB2), and HER4 (erbB4), and importantly, also HER receptor mutations;
this, in turn, leads to the inhibition of the proliferation of tumor
cells that overexpress these receptors. Mutations or
overexpression/amplification of EGFR family receptors have been
associated with a number of different cancers, including non-small cell
lung cancer (NSCLC), breast cancer, gastric cancer, etc. Currently,
Poziotinib is being investigated by Hanmi in several mid-stage trials in
different solid tumor indications including HER2-positive breast cancer.
(Phase 2 sponsored by National OncoVenture, a funding initiative by the
Korean government's National Cancer Center).
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 five
hematology/oncology drugs, and expects two FDA decisions in 2016.
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 Phase 2 and Phase 3 studies, many of which target
blockbuster markets. 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.® is a registered
trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. 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.
© 2016 Spectrum Pharmaceuticals, Inc. All Rights Reserved

View source version on businesswire.com: http://www.businesswire.com/news/home/20160307005523/en/
Spectrum Pharmaceuticals, Inc.
Shiv Kapoor
Vice President,
Strategic Planning & Investor Relations
702-835-6300
InvestorRelations@sppirx.com
Source: Spectrum Pharmaceuticals, Inc.
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