Hutchison China Meditech Limited China Phase II trial initiation in mesothelioma
March 31 2020 - 1:04AM
RNS Non-Regulatory
TIDMHCM
Hutchison China Meditech Limited
31 March 2020
Press Release
Chi-Med Initiates a Phase II Trial of HMPL-453 in Patients with
Advanced Malignant Mesothelioma in China
London: Tuesday, March 31, 2020: Hutchison China MediTech
Limited ("Chi-Med") (Nasdaq/AIM: HCM) has initiated a Phase II
study of HMPL-453, its novel small molecule inhibitor targeting
fibroblast growth factor receptors ("FGFR"), in patients with
advanced malignant mesothelioma.
The clinical study is a single-arm, multi-center, open-label
study, evaluating the efficacy, safety and pharmacokinetics of
HMPL-453 in historically confirmed patients with advanced malignant
mesothelioma that failed at least one line of systemic therapy.
The primary outcome measure is overall response rate (ORR).
Secondary outcome measures include preliminary efficacy such as
disease control rate (DCR), time to response (TTR), duration of
response (DoR), progression-free survival (PFS), and overall
survival (OS). The lead investigator of the study is Shun Lu,
Professor at Shanghai Chest Hospital, Jiao Tong University. Additional details may be found at clinicaltrials.gov, using identifier NCT04290325.
About F ibroblast Growth Factor Receptors ( 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.
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. Enrollment has
been completed for the dose escalation of the Phase I study of
HMPL-453 in China, for which additional details can be found at
clinicaltrials.gov, using identifier NCT03160833.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative biopharmaceutical
company committed, over the past twenty years, to the discovery and
global development of targeted therapies and immunotherapies for
the treatment of cancer and immunological diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world and extensive commercial infrastructure in
its home market of China. For more information, please visit:
www.chi-med.com.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile) xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile) bmiles@troutgroup.com
Asia - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile) jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 97 83 6894 (Mobile) y zhou@brunswickgroup.com
Nominated Advisor
Freddie Crossley / Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
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, including 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 press release, whether as a result of new
information, future events or circumstances or otherwise.
This information is provided by RNS, the news service of the
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Authority to act as a Primary Information Provider in the United
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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