Hutchison China Meditech Limited Chi-Med Phase I/Ib Trial of HMPL-523 in Lymphoma
04 October 2019 - 4:11PM
RNS Non-Regulatory
TIDMHCM
Hutchison China Meditech Limited
04 October 2019
Press Release
Chi-Med Initiates an International Phase I/Ib Trial of HMPL-523
in Patients with Advanced Relapsed or Refractory Lymphoma
London: Friday, October 4, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated an
international Phase I/Ib study of HMPL-523, its novel spleen
tyrosine kinase ("Syk") inhibitor, in patients with relapsed or
refractory lymphoma. The first patient was dosed on September 26,
2019 in the U.S.
The international clinical study, with sites in the U.S. and
Europe, is a multi-center, open-label, two-stage study, including
dose escalation and expansion, investigating the effects of
HMPL-523 administered orally to patients with relapsed or
refractory lymphoma. The primary outcome measures are safety and
tolerability. Secondary outcomes include pharmacokinetic (PK)
measurements and preliminary efficacy such as objective response
rate (ORR). The lead investigator of the study is Dr. Nathan
Fowler, Associate Professor, Department of Lymphoma/Myeloma, The
University of Texas MD Anderson Cancer Center, Houston, TX.
Additional details may be found at clinicaltrials.gov, using
identifier NCT03779113.
This study complements the ongoing Phase Ib dose expansion
program of HMPL-523 in Australia (clinicaltrials.gov identifier:
NCT02503033) and China (clinicaltrials.gov identifiers: NCT02857998
and NCT03483948) addressing a broad range of hematological cancers.
Preliminary results of the dose escalation stage in a Phase I study
in China of HMPL-523 in patients with relapsed or refractory B-cell
lymphomas were presented in 2018[1]. Outside of oncology, HMPL-523
is in Phase I study in patients with Immune Thrombocytopenia (ITP)
in China (clinicaltrials.gov identifier: NCT03951623).
About HMPL-523
HMPL-523 is a novel, highly selective and potent small molecule
inhibitor for oral administration targeting spleen tyrosine kinase,
also known as Syk. Syk is a major component in B-cell receptor
signaling and is an established therapeutic target in multiple
subtypes of B-cell lymphomas. Because B cell malignancies are
heterogeneous and patients commonly experience relapse despite
current therapies, there is a recognized need for new
therapeutics.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical
company which researches, develops, manufactures and markets
pharmaceutical products. Its Innovation Platform, Hutchison
MediPharma, has about 470 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies in oncology and autoimmune diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world. Chi-Med's Commercial Platform
manufactures, markets, and distributes prescription drugs and
consumer health products, covering an extensive network of
hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the
AIM market of the London Stock Exchange and the Nasdaq Global
Select Market. 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-523, including in combination with azacitidine, plans to
initiate clinical studies for HMPL-523 as a monotherapy or in
combinations, 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-523 as a monotherapy or in combinations 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-523 for a targeted indication and the sufficiency of funding.
In addition, as one of the Phase I studies in China relies on the
use of azacitidine as combination therapeutics with HMPL-523, such
risks and uncertainties include assumptions regarding the safety,
efficacy, supply and continued regulatory approval of azacitidine.
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
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
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 136 7179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Zhu, J et al., Preliminary Results from a Phase 1 Study of
HMPL-523, a Highly Selective Syk Inhibitor, in Chinese Patients
with Mature B-Cell Lymphomas. Blood. 2018; 132:5324. Published 2018
Nov 21. doi: https://doi.org/10.1182/blood-2018-99-111648.
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END
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