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news.US-based XBiotech has started enrolling patients into its revised US Phase III trial of its monoclonal True Human antibody therapy, Xilonix, in metastatic colorectal cancer patients.
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Xilonix is designed to block chronic inflammation associated with malignant tumor growth.
The US Phase III trial was initially launched in March 2013 and patients were enrolled at more than 60 US cancer centers.
Earlier, the trial was paused to propose to the FDA changes in inclusion criteria to allow broader eligibility for cancer patient enrollment.
The company said that the newly approved protocol allows recruitment of advanced, refractory colorectal cancer patients that includes those who have failed all standard therapies.
Stanford University School of Medicine professor of Medicine and principal investigator of the study Dr George Fisher said: "Xilonix is intended to target the inflammatory environment of tumor cells and in so doing, slow the growth and spread of the cancer while improving the symptoms associated with advanced disease.
"Preliminary results have been encouraging and the absence of serious side effects would be a welcome change from standard chemotherapy agents."
At the time of the protocol revision, 40 patients had entered the trial with about equal numbers in each arm.
The company said that an analysis of the primary and secondary endpoints was conducted, and though statistical significance was unachievable due to the relatively small number of patients, the trends observed were encouraging and suggested continuation of the trial.