TIDMHCM
Hutchison China Meditech Limited
16 January 2017
Press Release
Chi-Med Initiates a Phase II Study of Sulfatinib in Second-line
Biliary Tract Cancer in China
London: Monday, January 16, 2017: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that it has
initiated a Phase II study of sulfatinib in second-line biliary
tract cancer ("BTC") patients in China. Sulfatinib is an oral,
novel angio-immunokinase inhibitor that selectively targets
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. The first drug dose was
administered on January 9, 2017.
This Phase II study is a multi-center, single-arm, open-label
study to evaluate the efficacy and safety of sulfatinib as a
monotherapy in treating advanced or metastatic BTC patients who
failed one prior systemic therapy. The primary endpoint is
progression free survival ("PFS") at 16 weeks, with secondary
endpoints including objective response rate ("ORR"), disease
control rate ("DCR"), duration of response, PFS, overall survival
("OS") and safety. Additional details about this study may be found
at clinicaltrials.gov, using identifier NCT02966821.
About BTC
BTC, also known as cholangiocarcinoma, is a heterogeneous group
of rare but fatal malignancies arising from the biliary tract
epithelia, including intrahepatic cholangiocarcinoma and
extrahepatic cholangiocarcinoma. BTC is the second most frequently
occurring type of liver cancer in the world, after hepatocellular
carcinoma (HCC), accounting for approximately 15% of all liver
cancer cases(1) . In 2017, there will be approximately 18,000 new
BTC cases in the United States, according to the National Cancer
Institute. However, in China, the incidence can be up to 40 times
the rate observed in the Western world(2) .
Gemcitabine is the current first-line therapy for BTC patients,
either as a monotherapy or in combination with cisplatin, and there
is no established second-line therapy for this fatal disease
worldwide. The median life expectancy is less than 12 months for
patients with unresectable or metastatic disease at diagnosis.
Accordingly, we see a high unmet medical need for new targeted
treatment options.
[1] A Ananthakrishnan et al; Epidemiology of Primary and
Secondary Liver Cancers; Semin Intervent Radiol. 2006 Mar; 23(1):
47--63.
[2] JA Bridgewater et al; Biliary Tract Cancer: Epidemiology,
Radiotherapy, and Molecular Profiling; Am Soc Clin Oncol Educ Book.
2016;35:e194-203.
About Sulfatinib
Sulfatinib is an oral, novel angio-immunokinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
VEGFR, FGFR and 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.
In addition to the BTC trial, six sulfatinib clinical trials are
underway in China and the United States, including two Phase III
studies in neuroendocrine tumor patients (SANET-p and SANET-ep) and
a Phase II study in thyroid cancer patients.
The SANET-p trial is a randomized, double-blind,
placebo-controlled, multi-center, Phase III pivotal registration
trial to treat about 190 pathologically low or intermediate grade
pancreatic NET patients in China whose disease has progressed,
locally advanced or distant metastasized and for whom there is no
effective therapy. The primary endpoint is PFS, with secondary
endpoints including ORR, DCR, duration of response, time to
response and OS. Additional details of the SANET-p study may be
found at clinicaltrials.gov, using identifier NCT02589821. The
SANET-ep trial is similar to the SANET-p trial and is targeted at
treating about 270 non-pancreatic NET patients in China. Additional
details of the SANET-ep study may be found at clinicaltrials.gov,
using identifier NCT02588170.
Chi-Med is conducting an open-label Phase II clinical trial to
evaluate the efficacy and safety of sulfatinib in about 50 patients
with locally advanced or metastatic radioactive iodine-refractory
differentiated thyroid cancer or medullary thyroid cancer in China.
The primary endpoint is ORR, with secondary endpoints including the
safety and tolerability, DCR, time to response and PFS. Additional
details of this study may be found at clinicaltrials.gov, using
identifier NCT02614495.
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: 0001). 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
Christian Hogg, CEO +852 2121 8200
International Media Enquiries
Anthony Carlisle, +44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
Citigate Dewe Rogerson
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, +44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Citigate Dewe Rogerson
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
This information is provided by RNS
The company news service from the London Stock Exchange
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January 16, 2017 02:29 ET (07:29 GMT)