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.
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.
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