Hutchison China MediTech Limited ("Chi-Med")
(AIM: HCM)
Patient enrolment completion for fruquintinib's Phase II study in non-small cell lung cancer. Fruquintinib development moving rapidly in four parallel studies in non-small cell lung cancer, colorectal cancer and gastric cancer.
London: Friday, 6 March 2015: Chi-Med, today announces that Hutchison MediPharma Limited ("HMP"), its majority owned drug R&D company, has completed patient enrolment in a Phase II clinical trial of fruquintinib (HMPL-013) in non-small cell lung cancer ("NSCLC") patients in China. The proof-of-concept ("POC") study is investigating the efficacy and safety of fruquintinib, HMP's investigational small molecule inhibitor of vascular endothelial growth factor receptors ("VEGFR").
This randomised, double-blind, placebo-controlled, multi-centre, POC Phase II study is targeted at treating non-squamous NSCLC patients who have failed second-line standard chemotherapy. A total of 91 patients have now been randomised to receive fruquintinib plus best supportive care ("BSC") or placebo plus BSC at a 2:1 ratio. The primary endpoint is progression free survival, with secondary endpoints including disease control rate, overall response rate, overall survival and safety. As a result of the rapid patient enrolment, data from this trial is expected in mid of 2015.
Fruquintinib is designed to selectively inhibit VEGF receptors, namely VEGFR1, VEGFR2, and VEGFR3. In the first-in-human Phase I clinical trial 40 patients were treated with fruquintinib. Detailed results of the Phase I clinical trial are available at http://chi-med.com/eng/irinfo/presentations.htm, and were presented at the annual meeting of the American Association for Cancer Research in April 2013.
Based on the Phase I data in colorectal cancer ("CRC"), a Phase Ib study was initiated which treated a further 62 CRC patients. Detailed results of the Phase Ib clinical trial were presented at the annual meeting of the American Society of Clinical Oncology in May 2014, and also can be found at http://chi-med.com/eng/irinfo/presentations.htm.
In April 2014, HMP initiated the first POC Phase II study, which was a randomised, double-blind, placebo-controlled, multi-centre Phase II clinical trial targeted at patients with metastatic CRC. The POC Phase II study subsequently completed enrolment in August 2014, and will report data during the first half of 2015.
In October 2014, HMP initiated a Phase Ib dose-finding study of fruquintinib, in combination with paclitaxel, in second line gastric cancer patients.
In December 2014, HMP initiated FRESCO, a Phase III registration study in patients with locally advanced or metastatic CRC, who have failed at least two prior systemic antineoplastic therapies, including flouropyrimidine, oxaliplatin and irinotecan. FRESCO will enrol more than 400 patients in 25 centres in China, with top-line results expected in 2016.
In October 2013, HMP entered into a licensing, co-development and commercialisation agreement in China with Eli Lilly and Company for fruquintinib.
Ends
Enquiries
Chi-Med Christian Hogg, CEO |
Telephone: +852 2121 8200
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Panmure Gordon (UK) Limited |
Telephone: +44 20 7886 2500 |
Richard Gray Andrew Potts |
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Citigate Dewe Rogerson Anthony Carlisle David Dible |
Telephone: +44 20 7638 9571 Mobile: +44 7973 611 888 Mobile: +44 7967 566 919 |
Notes to Editors
HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of around 250 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 majority owned by Chi-Med. For more information, please visit: www.hmplglobal.com.
About Chi-Med
Chi-Med is a China-based healthcare group focused on researching, developing, manufacturing and selling pharmaceuticals and health-related consumer products. Its China Healthcare Division manufactures, markets and distributes prescription and over-the-counter pharmaceuticals in China. Its Drug R&D Division focuses on discovering and developing innovative therapeutics in oncology and autoimmune diseases. Its emerging Consumer Products Division focuses on organic and natural consumer products in Asia.
Chi-Med is majority owned by the multinational conglomerate Hutchison Whampoa Limited (SEHK:13). For more information, please visit: www.chi-med.com.