Company Website:
http://www.chi-med.com/
LONDON -- (Business Wire)
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) today
announces that a Phase II study of savolitinib has been initiated in
locally advanced or metastatic pulmonary sarcomatoid carcinoma (“PSC”)
in China. Savolitinib is a highly selective and potent oral c-Met
inhibitor with global first-in-class potential. The first drug dose was
administered on February 10, 2017.
This Phase II study is a multi-center, single-arm, open-label study to
evaluate the efficacy and safety of savolitinib as a monotherapy in
treating locally advanced or metastatic PSC patients harboring
mesenchymal epithelial transition (“Met”) gene alterations. The primary
endpoint is objective response rate (ORR), with secondary endpoints
including progression free survival (PFS), disease control rate (DCR),
duration of response (DoR), overall survival (OS) and safety. Additional
details about this study can be found at clinicaltrials.gov, using
identifier NCT02897479.
About PSC and Met gene alterations
PSC is a rare subset of poorly differentiated non-small cell lung cancer
(“NSCLC”). Containing a component with sarcoma-like (spindle and/or
giant cell) features, PSC accounts for approximately 0.4% of all cases
of lung cancer in the US, according to the Surveillance, Epidemiology
and End Results database. These tumors are highly aggressive with
outcomes significantly worse than other forms of NSCLC, and are more
resistant to conventional chemotherapies1,2. There is no
approved targeted therapy for this fatal disease.
The sarcomatoid component of some PSC tumors is believed to derive from
carcinoma cells through the activation of Met. Met gene exon 14 skipping
has been reported as one of the major genetic alterations in PSC, acting
as a negative control in Met signaling. This genetic alteration has been
found in approximately 20-30% of PSC patients3. As such, a
highly selective c-Met inhibitor may provide clinically meaningful
benefit to patients with PSC.
About Savolitinib
Savolitinib is a potential global first-in-class inhibitor of c-Met
(also known as mesenchymal epithelial transition factor) receptor
tyrosine kinase, an enzyme which has been shown to function abnormally
in many types of solid tumors. It was developed as a potent and highly
selective oral inhibitor specifically designed to address issues
observed in the clinic with first-generation c-Met inhibitors, including
renal toxicity.
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 USPrivate
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
savolitinib in PSC, plans to initiate clinical studies for savolitinib,
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 savolitinib 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 savolitinib 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 USSecurities 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.
1 S. Yendamuri et al; Outcomes of sarcomatoid carcinoma of
the lung: A Surveillance, Epidemiology, and End Results database analysis.
Surgery 2012 152(3) 397-402.
2 T Vieira et al; Efficacy of First-Line Chemotherapy in
Patients with Advanced Lung Sarcomatoid Carcinoma. J Thorac Oncol
2013 8(12) 1574-7.
3 J. Tong et al; MET Amplification and Exon 14 Splice Site
Mutation Define Unique Molecular Subgroups of Non–Small Cell Lung
Carcinoma with Poor Prognosis. Clin Cancer Res 2016 22(12) 3048-56.
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Contacts:
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Christian Hogg, CEO
+852
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or
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or
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or
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David Dible, +44 7967 566 919 (Mobile)
david.dible@citigatedr.co.uk
or
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Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886
2500
Source: Chi-Med
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