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Successful Phase III trial for Xilonix therapy in colorectal cancer is published in The Lancet Oncology.-XBiotech.

Read time: 1 mins
Last updated: 24th Jan 2017
Published: 24th Jan 2017
Source: Pharmawand

XBiotech recently completed a groundbreaking double-blind, placebo controlled Phase III trial to evaluate Xilonix therapy in colorectal cancer patients. The study, which used both innovative and established objective response criteria to evaluate Xilonix , grew out of collaboration between XBiotech and the Scientific Advisory Group of the European Medicines� Agency (EMA). The regulatory path was devised around an EMA Mandate to find new and better measures of efficacy for anti-tumor agents in treating patients with advanced cancer. New clinical endpoints were developed based on findings from an earlier study where cancer patients receiving the antibody exhibited remarkable symptomatic recovery that in turn was associated with marked improvement in overall survival.

Study results showed a 76 percent relative improvement in response rate in patients treated with Xilonix compared to placebo. Based on the Phase III results, which have been published in The Lancet Oncology, XBiotech is now seeking marketing approval for Xilonix in European Union member countries.

See- "MABp1 as a novel antibody treatment for advanced colorectal cancer: a randomised, double-blind, placebo-controlled, phase 3 study"- Dr Tamas Hickish, MD,Thierry Andre, MD, Lucjan Wyrwicz , MD, Mark Saunders , MBBS, et al.,-DOI: http://dx.doi.org/10.1016/S1470-2045(17)30006-2.

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