Hutchison China Meditech Limited Start of HMPL 689 Phase I Trial in China
August 29 2017 - 1:01AM
RNS Non-Regulatory
TIDMHCM
Hutchison China Meditech Limited
29 August 2017
Chi--Med Initiates a Phase I Clinical Trial of Selective PI3K
Inhibitor HMPL--689 in Lymphoma Patients in China
London: Tuesday, August 29, 2017: Hutchison China MediTech
Limited ("Chi--Med") (AIM/Nasdaq: HCM) has initiated a Phase I
clinical trial of HMPL--689 in China. HMPL-689 is a novel, highly
selective and potent small molecule inhibitor targeting
phosphoinositide-3 kinase delta isoform ("PI3K "), a key component
in the B-cell receptor ("BCR") signaling pathway.
This Phase I study is a multi--center, open--label, two--stage
study to evaluate safety, tolerability, pharmacokinetics ("PK") and
preliminary efficacy of HMPL-689 monotherapy in relapsed and/or
refractory non-Hodgkin lymphoma patients. During the initial
dose-escalation stage, the primary objective is to determine the
maximum tolerated dose (MTD) or the recommended Phase II dose
("RP2D"). Safety, tolerability and preliminary efficacy of HMPL-689
at the RP2D will be further studied in a subsequent dose-expansion
stage in which several subtypes of lymphoma patients will be
evaluated. Additional details about this study can be found at
clinicaltrials.gov, using identifier NCT03128164.
About HMPL-689
PI3K signaling is mediated by four different catalytic isoforms
(p110<ALPHA>, <BETA>, , ). The (delta) isoform is the
most critical isoform and a proven target in the BCR signaling
pathway. This isoform is restricted to hematopoietic cells and is
highly expressed in lymphoid cells.
HMPL-689 is a novel, potential best-in-class, highly selective
and potent small molecule inhibitor targeting the isoform PI3K .
HMPL-689 was designed for superior PI3K isoform selectivity, in
particular to not inhibit PI3K (gamma), to minimize the risk of
serious infection caused by immune suppression. In preclinical PK
studies, HMPL-689's PK properties have been found to be favorable
with expected good oral absorption, moderate tissue distribution
and low clearance. HMPL-689 is also expected to have low risk of
drug accumulation and drug-to-drug interaction and is highly
potent, particularly at the whole blood level.
A Phase I, first-in-human, dose escalation study in healthy
adult volunteers in Australia to evaluate the PK and safety profile
following single oral dosing HMPL-689 was completed in 2016.
Results were as expected with linear PK properties and good safety
profile. Additional details about this study can be found at
clinicaltrials.gov, using identifier NCT02631642.
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--689, plans to initiate further clinical studies for
HMPL--689, 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--689 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--689 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, Corporate Finance
& Development +852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications +1 (917) 570 7340 (Mobile) bmiles@bmccommunications.com
Susan Duffy, BMC Communications +1 (917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group +1 (917) 415 1750 (Mobile) mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRAPLMATMBTTMIR
(END) Dow Jones Newswires
August 29, 2017 02:01 ET (06:01 GMT)
Hutchmed (china) (LSE:HCM)
Historical Stock Chart
From Apr 2024 to May 2024
Hutchmed (china) (LSE:HCM)
Historical Stock Chart
From May 2023 to May 2024