TIDMHCM
RNS Number : 0424K
Hutchison China Meditech Limited
23 August 2019
Press Release
Chi-Med Initiates a Phase I Trial of HMPL-523 in Patients
with
Immune Thrombocytopenia (ITP) in China
London: Friday, August 23, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated a Phase I study
of HMPL-523, its novel spleen tyrosine kinase ("Syk") inhibitor, in
patients with immune thrombocytopenia ("ITP"), an autoimmune
disorder that can lead to increased risk of bleeding. The first ITP
patient was dosed on August 12, 2019 in China.
The study is a randomized, double-blinded, placebo-controlled
Phase Ib clinical trial investigating the safety, tolerability,
pharmacokinetics and preliminary efficacy of HMPL-523 in adult
patients with ITP. The primary endpoint is the number of patients
with any adverse event. The secondary endpoints are maximum plasma
concentration (C(max) ), area under the concentration-time curve in
a selected time interval (AUC(0-t) ), and rate of clinical
remission at week 8. The trial is comprised of a dose escalation
stage and a dose expansion stage. Approximately 50 to 60 patients
will be enrolled. Additional details may be found at
clinicaltrials.gov, using identifier NCT03951623.
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.
These cancers include acute myeloid leukemia, chronic lymphocytic
leukemia/small lymphocytic lymphoma, mantle cell lymphoma,
follicular lymphoma, marginal zone lymphoma, diffuse large B-cell
lymphoma and Waldenstrom's macroglobulinemia. 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) A Phase I dose escalation study in
Australia in healthy volunteers was also completed, showing that
HMPL-523 was generally well tolerated (clinicaltrials.gov
identifier: NCT02105129).
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 and autoimmune disorders.
About ITP
ITP is a type of thrombocytopenic defined as isolated low
platelet count (thrombocytopenia) with normal bone marrow and the
absence of other causes of thrombocytopenia. Patients with ITP
exhibit symptoms of petechiae, purpura, and gastrointestinal and/or
urinary mucosal tract bleeding.(2) ITP is also associated with
fatigue (reported in up to 39% of adults with ITP) and impaired
quality of life, across domains of emotional, functional and
reproductive health, and work or social life.(3-7) The incidence of
primary ITP in adults is 3.3/100,000 adults per year with a
prevalence of 9.5 per 100,000 adults.(8)
Adult ITP is a heterogeneous disease that can persist for years,
even with best available care, and treatments are infrequently
curative. Despite availability of several treatments with differing
mechanisms of action, chronicity of disease continues to be a
problem. Many patients develop resistance to treatment and thereby
are prone to relapse.(9) Thus, there remains a significant
population of patients who have limited sensitivity to currently
available agents and are in need of a new approach to
treatment.
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 440 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, 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.
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
Richard Gray / 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.
(2) Anne Zufferey, Rick Kapur, and John W. Semple. Pathogenesis
and Therapeutic Mechanisms in Immune Thrombocytopenia (ITP). J.
Clin. Med. 2017, 6(2), 16.
(3) McMillan R, Bussel JB, George JN, Lalla D, Nichol JL.
Self-reported health-related quality of life in adults with chronic
immune thrombocytopenic purpura. Am J Hematol. 2008
Feb;83(2):150-4.
(4) Snyder CF, Mathias SD, Cella D, Isitt JJ, Wu AW, Young J.
Health-related quality of life of immune thrombocytopenic purpura
patients: results from a web-based survey. Curr Med Res Opin. 2008
Oct;24(10):2767-76.
(5) Doobaree IU, Nandigam R, Bennett D, Newland A, Provan D.
Thromboembolism in adults with primary immune thrombocytopenia: a
systematic literature review and meta-analysis. Eur J Haematol.
2016 Oct;97(4):321-30.
(6) Sarpatwari A, Bennett D, Logie JW, Shukla A, Beach KJ,
Newland AC, Sanderson S, Provan D. Thromboembolic events among
adult patients with primary immune thrombocytopenia in the United
Kingdom General Practice Research Database. Haematologica. 2010
Jul;95(7):1167-75.
(7) Sarpatwari A, Watson S, Erqou S, Anderson H, Grainger J,
Higgins JP, Newland AC. Health-related lifestyle in adults and
children with primary immune thrombocytopenia (ITP). Br J Haematol.
2010 Oct;151(2):189-91.
(8) Lambert MP, Gernsheimer TB. Clinical updates in adult immune
thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835.
(9) Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs
P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B,
Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R,
Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ.
International consensus report on the investigation and management
of primary immune thrombocytopenia. Blood. 2010 Jan
14;115(2):168-86.
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END
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