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XBiotech Provides Update on Xilonix(TM) Phase III Programs in US and EU | ||
By: Nasdaq / GlobeNewswire - 23 Jul 2016 | Back to overview list |
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AUSTIN, Texas, July 22, 2016 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ:XBIT), developer of next-generation True Human(TM) antibody therapies, said today that the Independent Data Monitoring Committee (DMC) for the XCITE Phase III clinical study of Xilonix(TM) for the treatment of colorectal cancer, recently recommended study continuation without any amendment to the study design. The DMC convened as scheduled, subsequent to the enrollment of 400 patients into the study. The DMC mandate is to "monitor for early evidence of treatment harm and to routinely recommend to continue, suspend, or otherwise modify enrollment based on their findings." The DMC did not have any recommendations for the Company regarding any need for changes to the study operation. This is viewed as a positive assessment with respect to safety, as well as to key aspects of study execution. Another DMC meeting is scheduled to occur either after 600 patients have been enrolled, or potentially earlier if the study meets its first planned efficacy analysis milestone. Xilonix has been granted FDA fast-track review and the XCITE study is on schedule to reach its enrollment milestones in 2016. The Company's marketing authorization application for Xilonix for the treatment of colorectal cancer remains on schedule to achieve a decision in 2016 by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). The Company recently scheduled an in-person meeting with the CHMP. The Company believes the meeting will help advance the marketing authorization process and has agreed with the CHMP for the MAA to be reviewed under the standard assessment timetable, rather than the accelerated review timeline that was granted in April 2016. The Company says that the standard timetable will provide additional time to conduct the MAA process. The standard timetable is expected to add approximately 60-days to the review proceedings.
About Xilonix(TM) and Interleukin-1 alpha (IL-1alpha)
About True Human(TM) Therapeutic Antibodies
About XBiotech
Cautionary Note on Forward-Looking Statements
i Apte RN, Voronov E. Interleukin-1 a major pleiotropic cyto-kine in tumor-host interactions. Can Biol. 2002;12:277-290. ii Dinarello CA. Interleukin-1alpha neutralisation in patients with cancer. Lancet Oncol. 2014;15(6):552-553.
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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: XBiotech, Inc via GlobeNewswire
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Copyright 2016 Nasdaq / GlobeNewswire | Back to overview list |