Enrollment in now complete in XBiotech's (XBIT -1.6%) Phase 3 clinical trial, XCITE, assessing Fast Track-tagged Xilonix in patients with advanced colorectal cancer (CRC). The ~600-subject study is investigating Xilonix plus best supportive care (BSC) compared to placebo plus BSC. The primary endpoint is overall survival from baseline to month 18. Secondary endpoints include objective response rate (18 months), progression-free survival (18 months) and change in lean body mass (8 weeks).
An earlier Phase 3 study showed treatment with Xilonix in CRC resulted in a 76% increase in clinical response rate.
Xilonix is a True Human monoclonal antibody (IgG1k) that binds to interleukin-1 alpha, thereby blocking the inflammation that supports tumor growth, spread and symptomatic effects of the cancer. It is currently under accelerated review in Europe for CRC.
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