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French National Cancer Institute and XBiotech Join forces to Conduct Innovative Phase II/III Adaptive Multicenter Clinical Study for XBiotech’s New Cancer Drug for Colorectal Cancer
XBiotech to Supply INSERM its New Drug to Use in Combination Therapy for Treating Advanced Colorectal CancerAUSTIN, Texas, May 03, 2021 (GLOBE NEWSWIRE) --
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[{"type":"text","content":"XBiotech to Supply INSERM its New Drug to Use in Combination Therapy for Treating Advanced Colorectal CancerAUSTIN, Texas, May 03, 2021 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ: XBIT) announced today that it had reached an agreement to supply its new cancer drug XB20-01 to INSERM, and its Federation of Digestive Oncology group, a French organization which supports world-leading innovation for treating colorectal cancer. Colorectal is one of the most common forms of cancer in Europe and the United States, with nearly 150,000 new cases and 53,000 deaths expected in the US alone in 2021. The current chemotherapy regimen uses a Trifluridine/Tipiracil combination, drugs that interfere with the genetic material of cells in an effort to kill tumors. However, inflammation and toxicity from the chemotherapy is offset only by modest response rates and less than ideal outcomes. Thus, there is significant unmet medical need for this group of colorectal cancer patients. XBiotech’s new drug candidate XB20-01 targets an inflammatory process potentially involved in the growth and spread of colorectal cancer; and the new drug may also block inflammation caused by chemotherapy, potentially reducing side effects and improving the treatment effect of chemotherapy. The chair and lead investigator of the multicenter clinical study is Dr. François Ghiringhelli M.D. Ph.D, Director of INSERM, and Professor of Oncology at the University of Burgundy, Genetic and Immunotherapy Medical Institute. Dr. Ghiringhelli, a world-leading researcher in colorectal cancer, designed the study which features an innovative interim analysis to assess improvement in overall survival. If patients receiving XB20-01 have a predetermined improvement in survival compared to the placebo treated group, the randomized study will be expanded to enroll a phase III portion with overall survival as the primary outcome. Professor Ghiringhelli, also a Director at the prestigious INSERM center and Head of a Division specializing in \"Cancer and adaptive immune response\", commented, “This is a very exiting clinical trial, granted by the French Cancer Institute, for a very frequent and devastating disease. Currently very few drugs give promising results for these patients. In case of success, this trial could be practice changing.” John Simard CEO XBiotech stated, “We are honored to be able t...