Spectrum Pharmaceuticals Highlights Promising Preclinical Data Evaluating Poziotinib in Lung Cancer at the 17th IASLC World C...
December 08 2016 - 7:00AM
Business Wire
- Pre-clinical results show poziotinib
could potentially be effective in patients with non-small cell lung
cancer with EGFR exon 20 mutations.
- Computational modeling suggests that
due to its small size, poziotinib may overcome the steric hindrance
of the drug binding pocket.
- An investigator sponsored clinical
trial testing poziotinib in EGFR exon 20 mutant non-small cell lung
cancer patients is expected to begin enrollment soon to investigate
this hypothesis.
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 oral presentation of data from a preclinical study
evaluating poziotinib in lung cancer by scientists from MD Anderson
Cancer Center at the 17th International Association for the
Study of Lung Cancer (IASLC) World Conference on Lung Cancer
which took place in Vienna, Austria, December 4-7,
2016.
“We are honored to have an oral presentation on poziotinib
presented at the 17th IASLC World Conference,” said Rajesh C.
Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “These results show that poziotinib may work in a
subset of non-small cell lung cancer patients that have exon-20
mutations. Tumors with exon-20 mutations have generally not been
responsive to several other EGFR inhibitors. However, due to its
smaller size poziotinib is hypothesized to inhibit cell growth of
EGFR exon 20 insertions. These early results are very encouraging
and have the potential to be a transforming therapy for patients
who have little or no options and poor prognosis with median
progression free survival of 1.5 months. We are working closely
with the team at MD Anderson Cancer Center in expediting this
research and evaluating ways of serving the unmet medical need in
this area.”
Abstract/Oral Presentation #6203: Drug Repurposing to
Overcome De Novo Resistance of Non-Traditional EGFR Mutations:
Poziotinib inhibits EGFR exon 20 insertion mutations in
NSCLC
EGFR exon 20 insertions induce a shift in the structure of
cancer cells that prevents binding of many EGFR inhibitors. In
vitro, Ba/F3 cells with EGFR exon 20 insertions were screened
against several EGFR inhibitors including erlotinib, gefitinib,
afatinib, dacomitinib, neratinib, poziotinib, ibrutinib
rocilentinib, EGF816, and osimertinib. In Ba/F3 cells with EGFR
exon 20 insertions, most of the TKIs failed to inhibit growth of
EGFR exon 20 insertions with IC50 values above 100nM. However,
poziotinib significantly inhibited cell growth of all EGFR exon 20
insertions tested with an average IC50 value of 2.9nM, as compared
to osimertinib and rocilentinib (IC50 values =103nM and 850nM,
respectively). In vivo, poziotinib reduced ≥80% of tumor burden in
multiple mouse models. Computational modeling suggests that its
smaller structure gives poziotinib the potential to overcome the
steric hindrance of the drug binding pocket. An investigator
sponsored clinical trial testing poziotinib in EGFR exon 20 mutant
NSCLC patients is expected to begin enrollment soon.
About Poziotinib
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, and
gastric cancer. 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 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 affiliate. 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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Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor
Relations702-835-6300InvestorRelations@sppirx.com
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