Spectrum Pharmaceuticals Submits Phase 2 Breast Cancer Protocol to FDA as Part of an Investigational New Drug (IND) Applicati...
November 20 2015 - 7:00AM
Business Wire
- Spectrum Plans to Initiate a 70
Patient U.S. Based Breast Cancer Phase 2 Study as Soon as
Possible
- Poziotinib Has Already Been Studied
in Multiple Cancer Types in over 250 Patients and Has Shown
Activity in Breast Cancer, Lung Cancer and Gastric Cancer
- 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 Trastuzumab and Lapatinib
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 the Company has submitted an IND application to the
U.S. Food and Drug Administration (FDA) and plans to initiate a
Phase 2 breast cancer study in the U.S. as soon as possible.
“This Phase 2 study is an important step for us to solidify our
registration strategy in the U.S.,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum Pharmaceuticals.
“The potential target market for Poziotinib is large, and
metastatic breast cancer patients continue to progress despite
availability of several drugs. Poziotinib has shown promising early
clinical activity in Phase 1 trials in patients who had failed
multiple lines of treatment including the HER2-directed therapies,
trastuzumab and lapatinib. The U.S. Phase 2 trial was designed
based on learnings from Phase 1 and Hanmi’s ongoing Phase 2 trials
in Korea. We are planning a fast to market strategy as a single
agent in parallel with the development of a broader indication
using poziotinib in combination with other approved therapies for
use in earlier stage disease.”
The Phase 2 study is planned to be an open-label study that will
enroll approximately 70 patients with HER-2 positive metastatic
breast cancer, who have failed at least one or more HER-2 directed
therapy. The dose and schedule of oral poziotinib will be based on
clinical experience from the studies in Korea, and in addition
include the use of prophylactic therapies to help minimize known
side-effects of HER2-directed therapies.
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 EGFR-mutant NSCLC, gastric cancer, head &
neck cancer and HER2 positive breast cancer.
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 five 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; MARQIBO® (vinCRIStine sulfate LIPOSOME
injection) for intravenous infusion, for which the Company has
worldwide marketing rights,and BELEODAQ® (belinostat) for Injection
in the U.S. Additionally, Spectrum's pipeline includes three drugs
targeting blockbuster markets in advanced stages of clinical
development. Spectrum's strong track record in in-licensing and
acquiring differentiated drugs, and expertise and proven track
record 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®,
MARQIBO®, and BELEODAQ® are registered trademarks of Spectrum
Pharmaceuticals, Inc and its affiliates. REDEFINING CANCER CARE™,
EVOMELA™ and the Spectrum Pharmaceuticals logos are trademarks
owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are
the property of their respective owners.
© 2015 Spectrum Pharmaceuticals, Inc. All Rights Reserved
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Spectrum PharmaceuticalsShiv Kapoor, 702-835-6300Vice President,
Strategic Planning & Investor
RelationsInvestorRelations@sppirx.com
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