Spectrum Pharmaceuticals Initiates Phase 2 Breast Cancer Trial for Poziotinib, a Novel Pan-HER Inhibitor
March 07 2016 - 7:00AM
Business Wire
- 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
- 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
- Spectrum has worldwide rights,
excluding Korea and China
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
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version on businesswire.com: http://www.businesswire.com/news/home/20160307005523/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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