Chi-Med Initiates First-In-Human Clinical Trial of Novel FGFR Inhibitor HMPL-453 in Australia
14 February 2017 - 6:44PM
Business Wire
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
today announces that it has initiated the first-in-human (“FIH”)
Phase I clinical trial of HMPL-453 in Australia. 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 February 14, 2017.
FGFRs are a sub-family of receptor tyrosine kinases. Activation
of FGFR signaling pathways is central to several biological
processes, including angiogenesis, tissue growth and repair. 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.
The FIH dose-escalation trial aims to evaluate the safety,
tolerability, pharmacokinetics and preliminary anti-tumor activity
of HMPL-453 in patients with advanced or metastatic solid
malignancies, who have failed or are unable to tolerate standard
therapies or for whom no standard therapies exist. This open-label
study consists of two preliminary phases, a dose-escalation (stage
1) and a dose-expansion stage (stage 2).
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. Additional
details about this study may 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 announcement 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 candidate HMPL-453 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 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 announcement,
whether as a result of new information, future events or
circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
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Chi-MedInvestor EnquiriesChristian Hogg, CEO+852
2121 8200orInternational Media EnquiriesAnthony
Carlisle,Citigate Dewe Rogerson+44 7973 611 888
(Mobile)anthony.carlisle@cdrconsultancy.co.ukorU.S. Based Media
EnquiriesBrad Miles, BMC Communications+1 (917) 570 7340
(Mobile)bmiles@bmccommunications.comorSusan Duffy, BMC
Communications+1 (917) 499 8887
(Mobile)sduffy@bmccommunications.comorInvestor RelationsMatt
Beck, The Trout Group+1 (917) 415 1750
(Mobile)mbeck@troutgroup.comorDavid DibleCitigate Dewe Rogerson+44
7967 566 919 (Mobile)david.dible@citigatedr.co.ukorPanmure
Gordon (UK) LimitedRichard Gray / Andrew Potts+44 (20) 7886
2500
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