TIDMHCM
Hutchison China Meditech Limited
22 June 2017
Press Release
Chi--Med Initiates a Phase I/II Clinical Trial of Novel FGFR
Inhibitor HMPL--453 in China
London: Thursday, June 22, 2017: Hutchison China MediTech
Limited ("Chi--Med") (AIM/Nasdaq: HCM) has just initiated a Phase
I/II clinical trial of HMPL--453 in China. HMPL--453 is a novel,
highly selective and potent small molecule inhibitor targeting
fibroblast growth factor receptor ("FGFR"). The first drug dose was
administered on June 19, 2017. This study complements the
first-in-human Phase I clinical trial in Australia that was
initiated earlier this year.
This Phase I/II study is a multi--center, single--arm,
open--label, two--stage study to evaluate safety, tolerability,
pharmacokinetics ("PK") and preliminary efficacy of HMPL--453
monotherapy in patients with solid tumors harboring FGFR genetic
alterations. The dose-escalation stage will enroll patients with
locally advanced or metastatic solid tumors, for whom standard
therapy either does not exist or has proven to be ineffective or
intolerable, regardless genetic status, to determine the maximum
tolerated dose (MTD) and recommended Phase II dose ("RP2D").
The dose-escalation will be followed by a dose-expansion stage,
which will further evaluate safety, tolerability and PK as well as
preliminary anti-tumor efficacy at the RP2D. This stage will enroll
primarily cancer patients harboring FGFR dysregulated tumors,
including those with advanced bladder cancer, advanced
cholangiocarcinoma and other solid tumors. For this second stage,
the primary endpoint is objective response rate (ORR), with
secondary endpoints including duration of response (DoR), disease
control rate (DCR), progression free survival (PFS), overall
survival (OS) and safety. Additional details about this study can
be found at clinicaltrials.gov, using identifier NCT03160833.
About bladder cancer and cholangiocarcinoma
Bladder cancer makes up approximately 90% of urothelial
carcinomas. Bladder cancer is the sixth most common cancer in the
U.S., and the ninth most common cancer in China, with about 80,000
new cases annually in both countries.([[1]], [) ([2]]) In the U.S.
the five-year survival rate for those whose disease has
metastasized is approximately 5%.([) (1) (]) Despite advances in
the treatment of locally advanced or metastatic urothelial
carcinoma, the prognosis for patients remains poor and more
treatment options are needed.
A highly unmet medical need around the world, cholangiocarcinoma
(bile duct cancer, "CCA") accounts for approximately 3% of all
gastrointestinal cancers and is the most common malignancy of the
biliary tract (the combined system of the liver, gall bladder and
bile ducts).([[3]]) CCA is classified as intrahepatic or
extrahepatic based on anatomical location, with studies suggesting
that the incidence of intrahepatic CCA in particular is
increasing.([[4]]) Currently CCA has a bleak prognosis, with a
5-year survival rate of less than 5%.([[5]])
About FGFR
FGFRs are a sub--family of receptor tyrosine kinases. Activation
of FGFR signaling pathways is central to several biological
processes. In normal physiology, FGF/FGFR signaling is involved in
embryonic development (organogenesis and morphogenesis), tissue
repair, angiogenesis, neuroendocrine and metabolism homeostasis.
Given its complexity and critical role in a number of important
physiological processes, aberrant FGFR signaling has been found to
be a driving force in tumor growth, promotion of angiogenesis, as
well as conferring resistance to anti--tumor therapies. To date,
there are no approved therapies specifically targeting the FGFR
signaling pathway.
About HMPL--453
HMPL--453 is a novel, highly selective and potent small molecule
inhibitor targeting fibroblast growth factor receptors 1, 2 and 3.
In pre--clinical studies, HMPL--453 demonstrated superior potency
and better kinase selectivity as compared to other drugs in the
same class, as well as a favorable safety profile. Chi--Med is also
conducting a Phase I study of HMPL--453 in Australia, for which
additional details can be found at clinicaltrials.gov, using
identifier NCT02966171.
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
HMPL--453, plans to initiate clinical studies for HMPL--453, 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 candidates HMPL--453
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 HMPL--453 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
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@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
[1] National Cancer Institute. The Surveillance, Epidemiology,
and End Results (SEER): Cancer Stat Facts: Bladder Cancer.
Available at: https://seer.cancer.gov/statfacts/html/urinb.html.
Accessed May 23, 2017.
[2] R. Zheng et al, National estimates of cancer prevalence in
China 2011, Cancer Letters 2016 370(1) 33-38.
[3] A. Bergquist et al, Epidemiology of cholangiocarcinoma, Best
Pract Res Clin Gastroenterol 2015 29(2) 221-32.
[4] T. Patel, Cholangiocarcinoma, Nat Clin Pract Gastroenterol
Hepatol 2006 3(1) 33-42.
[5] J. Byrling et al, Cholangiocarcinoma-current classification
and challenges towards personalised medicine, Scand J Gastroenterol
2016 51(6) 641-3.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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