TIDMHCM
Hutchison China Meditech Limited
23 July 2018
Press Release
Chi-Med Initiates a Phase Ib/II Proof-of-Concept Trial of
Sulfatinib in Pancreatic Neuroendocrine Tumors and Biliary Tract
Cancer in the United States
London: Monday, July 23, 2018: Hutchison China MediTech Limited
("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase Ib/II
proof-of-concept study of sulfatinib in pancreatic neuroendocrine
tumors ("NET") patients and in biliary tract cancer ("BTC")
patients in the U.S.. Sulfatinib is an oral small molecule
angio-immuno kinase inhibitor that can simultaneously block tumor
angiogenesis and immune evasion. This study follows several trials
that are underway in China, including two Phase III studies in
pancreatic and non-pancreatic NET that commenced after positive
results from a Phase II study, and a Phase II study in BTC
patients. In addition, a Phase I dose escalation part of this study
in the U.S. was recently completed.
This proof-of-concept study is a multi-center, single-arm,
open-label study to evaluate the efficacy and safety of sulfatinib
as a monotherapy in (a) patients with advanced BTC that have
progressed on standard first-line chemotherapy, and (b) in patients
with advanced pancreatic NET. The primary and secondary endpoints
include progression-free survival ("PFS") rate, objective response
rate ("ORR"), disease control rate ("DCR"), duration of response
("DoR"), time to response, overall survival ("OS"), safety and
tolerability. Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT02549937.
About Sulfatinib
Sulfatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptor ("VEGFR"), fibroblast
growth factor receptor ("FGFR") and colony stimulating factor-1
receptor ("CSF-1R"), three key tyrosine kinase receptors involved
in tumor angiogenesis and immune evasion. Inhibition of the VEGFR
signaling pathway can act to stop angiogenesis, the growth of the
vasculature around the tumor, and thereby starve the tumor of the
nutrients and oxygen it needs to grow rapidly. Aberrant activation
of the FGFR signaling pathway, which can be increased by anti-VEGFR
therapy treatment, is shown to be associated with cancer
progression by promoting tumor growth, angiogenesis and formation
of the myeloid derived suppressor cells. Inhibition of the CSF-1R
signaling pathway blocks the activation of tumor-associated
macrophages, which are involved in suppressing immune responses
against tumors. Its unique angio-immuno kinase profile supports
sulfatinib as a potentially attractive candidate for exploration of
possible combinations with checkpoint inhibitors against various
cancers.
Sulfatinib is the first oncology candidate that we have taken
through proof-of-concept in China and subsequently started clinical
development in the U.S. We are currently conducting studies in six
target patient populations on sulfatinib and retain all rights to
sulfatinib worldwide.
About Sulfatinib Development in China
Sulfatinib is currently in development as a single agent for
patients with NET, thyroid cancer and BTC in China.
Pancreatic NET: In March 2016, we initiated the SANET-p study,
which is a randomized, double-blind, placebo-controlled,
multi-center, Phase III pivotal registration trial to treat about
190 patients with low- or intermediate-grade, advanced pancreatic
NET in China. The primary endpoint is PFS, with secondary endpoints
including ORR, DCR, DoR, time to response, OS, safety and
tolerability. Additional details of the SANET-p study may be found
at clinicaltrials.gov, using identifier NCT02589821. We expect to
complete enrollment in 2019 and present top-line results
thereafter.
Extra-pancreatic NET: The SANET-ep study, which was initiated in
December 2015, is similar to the SANET-p study and is targeted at
treating about 270 patients with advanced extra-pancreatic NET in
China. Additional details of the SANET-ep study may be found at
clinicaltrials.gov, using identifier NCT02588170. We expect to
complete enrollment in 2019 and present top-line results
thereafter.
Thyroid cancer: In March 2016, we initiated Phase II in two
target patient populations in China to evaluate the efficacy and
safety of sulfatinib in patients with advanced medullary thyroid
cancer and iodine-refractory differentiated thyroid cancer.
Additional details of this study may be found at
clinicaltrials.gov, using identifier NCT02614495.
BTC: In January 2017, we began a Phase II study in patients with
BTC (also known as cholangiocarcinoma), a heterogeneous group of
rare malignancies arising from the biliary tract epithelia. Gemzar
is the currently approved first-line therapy for biliary tract
cancer patients, with a total of approximately 18,000 new patients
per year in the U.S. according to the National Cancer Institute,
but median survival is less than 12 months for patients with
unresectable or metastatic disease at diagnosis. As a result, we
see a major unmet medical need for patients who have progressed
when being treated with Gemzar, and sulfatinib may offer a new
targeted treatment option in this tumor type. Additional details of
this study may be found at clinicaltrials.gov, using identifier
NCT02966821.
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
sulfatinib, plans to initiate clinical studies for sulfatinib, 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 sulfatinib
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 sulfatinib 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, +44 7973 611 888 (Mobile)
Citigate Dewe Rogerson anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Susan Duffy, Solebury Trout +1 (917) 499 8887 (Mobile)
sduffy@troutgroup.com
Investor Relations
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
David Dible, +44 7967 566 919 (Mobile)
Citigate Dewe Rogerson david.dible@citigatedewerogerson.com
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
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END
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