Hutchison China Meditech Limited Chi-Med initiates Phase I trial (0187L)
03 Septembre 2019 - 8:01AM
UK Regulatory
TIDMHCM
RNS Number : 0187L
Hutchison China Meditech Limited
03 September 2019
Press Release
Chi-Med Initiates an International Phase I/Ib Trial of HMPL-689
in Patients with Advanced Relapsed or Refractory Lymphoma
London: Tuesday, September 3, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) has initiated an
international Phase I/Ib study of HMPL-689, its novel, highly
selective and potent small molecule phosphoinositide-3 kinase delta
isoform ("PI3K ") inhibitor, in patients with relapsed or
refractory lymphoma. The first patient was dosed on August 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-689 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 co-lead investigators of the study are Dr. Nilanjan
Ghosh (Lymphoma Program Director, Levine Cancer Institute-Morehead,
Charlotte, NC), and Dr. Jonathan B. Cohen (Associate Professor,
Department of Hematology and Medical Oncology, Emory University
School of Medicine, Atlanta, GA). Additional details may be found
at clinicaltrials.gov, using identifier NCT03786926.
This study complements the ongoing Phase I/Ib dose escalation
and expansion study of HMPL-689 in China (clinicaltrials.gov
identifier: NCT03128164) addressing a broad range of hematological
cancers. A Phase I dose escalation study in Australia in healthy
adult volunteers to evaluate HMPL-689's PK and safety profile
following single oral dosing was completed in 2016
(clinicaltrials.gov identifier: NCT02631642).
About HMPL-689
HMPL-689 is a novel, potential best-in-class, highly selective
and potent small molecule inhibitor targeting the isoform PI3K . 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.
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--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 +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
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END
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