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Hutchison China Meditech Limited
06 March 2018
Press Release
Chi-Med Initiates a Phase Ib/II Proof-of-Concept Trial of
Epitinib in Glioblastoma in China
London: Tuesday, March 6, 2018: Hutchison China MediTech Limited
("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase Ib/II
proof-of-concept study of epitinib in glioblastoma patients with
epidermal growth factor receptor ("EGFR") gene amplification in
China. Glioblastoma is a primary brain cancer that harbors high
levels of EGFR gene amplification. Epitinib is a potent and highly
selective oral EGFR inhibitor that has demonstrated penetration of
the blood-brain barrier and encouraging efficacy in clinical
studies in other indications.
This proof-of-concept study is a multi-center, single-arm,
open-label study to evaluate the efficacy and safety of epitinib as
a monotherapy in patients with EGFR gene amplified, histologically
confirmed glioblastoma. The primary endpoint is objective response
rate ("ORR"). Additional details about this study may be found at
clinicaltrials.gov, using identifier NCT03231501.
In addition to this glioblastoma study, epitinib is being
developed for non-small cell lung cancer ("NSCLC") patients with
activating EGFR mutations that have developed brain metastases.
Epitinib has demonstrated brain penetration and encouraging
efficacy in these clinical studies and in preclinical studies.
About glioblastoma and epitinib
Glioblastoma is the most aggressive of the gliomas, which are
tumors that arise from glial cells or their precursors within the
central nervous system ("CNS"). Glioblastoma is classified as Grade
IV under the World Health Organization grading of CNS tumors[1] and
is the most common brain and CNS malignancy, accounting for 47% of
such tumors. In 2017, there were approximately 12,000 new
glioblastoma cases in the United States, according to the Central
Brain Tumor Registry of the United States.[2] In 2015, there were
approximately 101,600 new brain or CNS cancer cases in China.[3]
The standard of care for treatment is surgery, followed by
radiotherapy and chemotherapy. Median survival is approximately 15
months, and the five-year survival rate is 5.5%.2,[4] There are
limited treatment options for glioblastoma patients, particularly
for patients with recurrent glioblastoma.
EGFR gene amplification has been identified in about half of
glioblastoma patients, according to The Cancer Genome Atlas
Research Network, and hence is a potential therapeutic target in
glioblastoma.[5] However, currently marketed first generation EGFR
inhibitors cannot penetrate the blood-brain barrier effectively,
leaving patients without an effective targeted therapy.[6] In
contrast, epitinib (HMPL-813) is designed for optimal blood-brain
barrier penetration, allowing for higher drug exposure in the brain
than the currently marketed first generation EGFR inhibitors.
About epitinib in NSCLC with brain metastasis
In December 2016, preliminary results were presented from a
Phase Ib trial of epitinib in first-line NSCLC. Epitinib has been
shown to be well tolerated with encouraging efficacy with an ORR
(lung and brain) of 62% in all patients not previously treated with
an EGFR inhibitor, and an ORR of 70% (including both confirmed and
unconfirmed partial responses) in such patients who also had
measurable brain metastasis and were c-MET negative
(clinicaltrials.gov identifier NCT02590952). Based on further data
from that Phase Ib and driven by the major unmet medical need, we
are preparing to initiate a Phase III pivotal study of epitinib in
EGFR mutant NSCLC patients with brain metastasis in China in
2018.
About Chi--Med
Chi--Med is an innovative biopharmaceutical company which
researches, develops, manufactures and sells pharmaceuticals and
healthcare products. Its Innovation Platform, Hutchison MediPharma
Limited, focuses on discovering and developing innovative
therapeutics in oncology and autoimmune diseases for the global
market. Its Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products in
China.
Chi--Med is majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 1). For more information, please
visit: www.chi--med.com.
Forward--Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect Chi-Med's current expectations regarding future
events, including its expectations for the clinical development of
epitinib, plans to initiate clinical studies for epitinib, its
expectations as to whether such studies would meet their primary or
secondary endpoints, and its expectations as to the timing of the
completion and the release of results from such studies.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding enrollment rates, timing and availability of subjects
meeting a study's inclusion and exclusion criteria, changes to
clinical protocols or regulatory requirements, unexpected adverse
events or safety issues, the ability of drug candidate epitinib to
meet the primary or secondary endpoint of a study, to obtain
regulatory approval in different jurisdictions, to gain commercial
acceptance after obtaining regulatory approval, the potential
market of epitinib for a targeted indication and the sufficiency of
funding. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. For further discussion of these
and other risks, see Chi-Med's filings with the U.S. Securities and
Exchange Commission and on AIM. Chi-Med undertakes no obligation to
update or revise the information contained in this press release,
whether as a result of new information, future events or
circumstances or otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President, Corporate Finance
& Development +852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications +1 (917) 570 7340 (Mobile) bmiles@bmccommunications.com
Susan Duffy, BMC Communications +1 (917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group +1 (917) 415 1750 (Mobile) mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile) david.dible@citigatedewerogerson.com
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
[1] D. Louis et al, The 2007 WHO Classification of Tumours of
the Central Nervous System. Acta Neuropathol 2007 114(2) 97-109. D.
Louis et al, The 2016 WHO Classification of Tumours of the Central
Nervous System: a summary. Acta Neuropathol Acta Neuropathol (2016)
131: 803.
[2] Q. Ostrom et al, CBTRUS Statistical Report: Primary Brain
and Other Central Nervous System Tumors Diagnosed in the United
States in 2009 - 2013. Neuro-Oncology 2016 18 (suppl 5) v1-75.
[3] W. Chen et al, Cancer statistics in China, 2015. CA: A
Cancer Journal for Clinicians 2016 66: 115-132.
[4] I. Jovčevska et al, Glioma and glioblastoma - how much do we
(not) know? Mol Clin Oncol 2013 1(6) 935-941.
[5] C.W. Brennan et al, The somatic genomic landscape of
glioblastoma. Cell 2013 155(2) 462-77.
[6] R. Chen et al, Targeted therapeutics in patients with
high-grade gliomas: Past, Present, and Future. Curr Treat Options
Oncol 2016 17(8) 42.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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