Chi-Med initiates sulfatinib Phase II clinical trial in thyroid cancer

LONDON--()--Hutchison China MediTech Limited (“Chi-Med”) (AIM: HCM) today announces that Hutchison MediPharma Limited (“HMP”), its drug R&D subsidiary, has initiated an open-label Phase II clinical trial to evaluate the efficacy and safety of sulfatinib (HMPL-012) in patients with locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (“DTC”) or medullary thyroid cancer (“MTC”) in China. The first patient was dosed on March 1, 2016.

HMP plans to enroll approximately 50 DTC and MTC patients into this study, with approximately 25 patients in each tumor type. The primary objective is to evaluate the objective response rate (“ORR”), while secondary and exploratory objectives include the evaluation of safety and tolerability, other efficacy parameters, pharmacokinetics, and tumor biomarkers. The study employs a two-stage design in which 15 subjects of each tumor type will be enrolled in the first stage. An additional 10 subjects in each tumor type will be enrolled after efficacy assessment in the second stage. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT02614495.

Sulfatinib is an oral drug candidate that selectively inhibits the tyrosine kinase activity associated with the vascular endothelial growth factor receptor (“VEGFR”) and fibroblast growth receptor (“FGFR”), two tyrosine kinase receptors associated with angiogenesis and tumor growth. HMP believes that sulfatinib’s VEGFR/FGFR1 inhibition profile has strong potential in second-line thyroid cancer patients, particularly in China where there are few safe and effective treatment options for this patient population.

In addition to the thyroid cancer trial, HMP is conducting or in the process of initiating four clinical trials in neuroendocrine tumors (“NETs”).

Ends

About thyroid cancer

Thyroid cancer is the most commonly diagnosed endocrine malignancy. Global incidence rates have increased sharply and continuously over the past few decades. According to the National Cancer Institute (“NCI”), in the U.S., incidence rates of thyroid cancer have increased by an average of 5% each year over the last 10 years. Further, an article published in Cancer Research estimates that it could become the fourth most commonly diagnosed cancer by 2030. In China, thyroid cancer is now the fastest growing tumor type and accounted for approximately 2% of all new cancer cases reported in 2015, according to the National Central Cancer Registry of China (“NCCRC”).

This rise in incidence has been most dramatic in women. According to through the NCCRC, 67,900 new cases were reported in women compared to just 22,200 in men in China in 2015. Thyroid cancer now represents the most frequently diagnosed cancer in Chinese women under the age of 30. In the U.S., incidence rates of thyroid cancer are three-fold higher in women than in men, according to the NCI.

About HMP

HMP is a novel drug R&D company focusing on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases. With a team of around 290 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China. HMP is a subsidiary of Chi-Med. For more information, please visit: www.hmplglobal.com.

About Chi-Med

Chi-Med is a China-based, globally-focused healthcare group which researches, develops, manufactures and sells pharmaceuticals and health-related consumer products. Its Innovation Platform 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 announcement contains forward-looking statements that reflect Chi-Med’s current expectations regarding future events, including its plans to initiate clinical studies for its drug candidates in the targeted indications, 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 enrolment 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 a drug candidate to meet the primary or secondary endpoint of a study, the ability of a drug candidate to obtain regulatory approval in different jurisdictions, the ability of a drug candidate to gain commercial acceptance after obtaining regulatory approval 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. Chi-Med undertakes no obligation to update or revise the information contained in this announcement, whether as a result of new information, future events or circumstances or otherwise.

Contacts

Chi-Med
Christian Hogg, CEO
Telephone: +852 2121 8200
or
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts
Telephone: +44 20 7886 2500
or
Citigate Dewe Rogerson
Telephone: +44 20 7638 9571
Anthony Carlisle
Mobile: +44 7973 611 888
David Dible
Mobile: +44 7967 566 919

Recent Stories

RSS feed for Chi-Med

Chi-Med