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XBiotech Announces First Patient Enrolled in Clinical Trial Evaluating XB2001 for the Treatment of Pancreatic Cancer
XB2001 Is a Novel Therapy that Interrupts Inflammation to Potentially Block Growth and Spread of Tumors and to Reduce Toxicity of Chemotherapy
About this update from Xbiotech Inc.
[{"type":"text","content":"XB2001 Is a Novel Therapy that Interrupts Inflammation to Potentially Block Growth and Spread of Tumors and to Reduce Toxicity of Chemotherapy TreatmentAUSTIN, Texas, June 23, 2021 (GLOBE NEWSWIRE) -- XBiotech Inc. (NASDAQ: XBIT) has enrolled the first patient in its 1-BETTER study, a randomized, double-blind, placebo-controlled clinical study to evaluate XB2001 in combination chemotherapy for treatment of Pancreatic Cancer. XBiotech’s novel anti-cancer agent, XB2001, is being assessed in combination with ONIVYDE + 5-FU/LV chemotherapy regimens. Safety and tolerability of the regimen, as well as progression-free survival, overall survival and time-to-treatment-failure will be assessed in the study. XB2001 blocks inflammation pathways turned on by tumors that help tumors vascularize, spread and cause collateral damage to healthy tissues. By using XB2001 to block inflammation in pancreatic cancer, investigators also hope to see a reduction in serious adverse events and reduced hospitalizations of subjects. Moreover, the anti-inflammatory effects of XB2001 may make the chemotherapy more effective and less toxic. The study is also investigating a novel clinical endpoint that XBiotech calls the “clinical benefit response”, which involves radiological assessment of muscle mass and patient reported measures of pain, fatigue and appetite. In earlier clinical studies in advanced cancer patients, XBiotech discovered that subjects with preserved muscle mass and stabilization or improvement of these symptoms, had dramatically improved overall survival. The Company previously validated this endpoint in a phase III study in colorectal cancer patients and will explore this endpoint now with its new drug in pancreatic cancer. The current study will commence with a Phase 1 portion to establish safety, tolerability and dosing of XB2001 in combination with ONIVYDE+5-FU/LV. The Phase I portion will serve to establish a recommended Phase 2 dose, which will involve enrollment of 60 patients randomized to receive either placebo+ONIVYDE+5-FU/LV or XB2001+ONIVYDE+5-FU/LV for up to 12 cycles. Dr. Carl Gray, Principal Investigator at Community Cancer Trials of Utah, site of first patient enrollment, commented, “Pancreatic cancer remains an aggressive and difficult form of cancer to treat. If we can use XB2001 to improve outcomes and increase the tolerabil...