Chi-Med Initiates Fruquintinib U.S. Clinical Trials
December 15 2017 - 2:00AM
Business Wire
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
has initiated the United States Phase I bridging clinical trial of
fruquintinib. Fruquintinib is a highly selective and potent oral
inhibitor of vascular endothelial growth factor receptors (“VEGFR”)
1, 2 and 3, that has met its primary endpoint in several Phase II
and III clinical trials in China for the treatment of colorectal,
lung and gastric cancers. The clinical study in the U.S. is a
multi-center, open-label, Phase I clinical study to evaluate the
safety, tolerability and pharmacokinetics of fruquintinib in U.S.
patients with advanced solid tumors. The first drug dose was
administered earlier this month. Additional details about this
study may be found at clinicaltrials.gov, using identifier
NCT03251378.
About Fruquintinib Development in China
Colorectal cancer: The China Food and Drug Administration
(“CFDA”) acknowledged acceptance of the New Drug Application (“NDA”) for fruquintinib for the
treatment of patients with advanced colorectal cancer (“CRC”) in
June 2017. Fruquintinib was subsequently awarded priority review
status in view of its significant clinical value, according to a
CFDA announcement in September 2017. The NDA is supported by data
from the successful FRESCO study, a Phase III pivotal registration
trial of fruquintinib in 416 patients with CRC in China, which was
highlighted in an oral presentation at the American Society of
Clinical Oncology Annual Meeting held on June 5, 2017
(clinicaltrials.gov identifier NCT02314819). The FRESCO study
followed an initial Phase I trial in 40 solid tumor patients, a
Phase Ib study in 62 CRC patients, and a Phase II clinical trial in
71 CRC patients.
Lung cancer: Fruquintinib is being studied in a Phase III
pivotal trial in approximately 520 third-line non-small cell lung
cancer (“NSCLC”) patients, known as the FALUCA study
(clinicaltrials.gov identifier NCT02691299), following a Phase II
clinical trial in 91 third-line NSCLC patients. Fruquintinib is
concurrently being studied in a Phase II study in combination with
Iressa® (gefitinib) in first-line setting for patients with
advanced or metastatic NSCLC (clinicaltrials.gov identifier
NCT02976116).
Gastric cancer: In October 2017, Chi-Med initiated a pivotal
Phase III clinical trial of fruquintinib in combination with Taxol®
(paclitaxel), known as the FRUTIGA study, for the treatment of over
500 patients with advanced gastric or gastroesophageal junction
(GEJ) adenocarcinoma (clinicaltrials.gov identifier
NCT03223376).
In China, fruquintinib is jointly developed with Eli Lilly and
Company.
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule
drug candidate that has been shown to inhibit VEGFR 24 hours a day
via an oral dose, with lower off-target toxicities compared to
other targeted therapies. Its tolerability, along with its clean
drug-drug interaction profile demonstrated to date, may enable
rational combination with other cancer therapies such as
chemotherapy and other targeted therapies, which are being studied
in our ongoing clinical trials of fruquintinib.
At an advanced stage, tumors secrete large amounts of vascular
endothelial growth factor (“VEGF”), a protein ligand, to stimulate
formation of excessive vasculature (angiogenesis) around the tumor
to provide greater blood flow, oxygen, and nutrients to the tumor.
VEGF and VEGFR play pivotal roles in tumor-related angiogenesis,
and fruquintinib inhibits the VEGF/VEGFR pathway. This represents
an important therapeutic strategy in blocking the development of
new blood vessels essential for tumors to grow and invade.
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: 1). 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
fruquintinib, plans to initiate clinical studies for fruquintinib,
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 fruquintinib 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 fruquintinib 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.
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+44 7967 566 919
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