XBIT - FDA gives go-ahead for XBiotech's XB2001 combo therapy in pancreatic cancer

XBiotech (XBIT) announces that the FDA has granted permission to commence clinical trials with its novel drug candidate for treating patients with pancreatic cancer. The Phase I/II clinical study will evaluate XBiotech’s new drug candidate, XB2001, when added to the ONIVYDE/5-FU combination therapy.Clinical endpoints in the study are safety, overall survival, objective response rate, progression free survival, time to treatment failure, clinical benefit response, number of severe adverse advents, as well as biological measures of experimental drug activity.The Phase 1 portion of the study will examine increasing doses of XBIT's new drug and assess tolerability of the combination at escalating doses.Once a safe dose has been determined, the phase 2 portion will begin, enrolling 60 patients, which will be randomized to receive treatment with ONIVYDE/5-FU or ONIVYDE/5-FU combined with XB2001. XBiotech’s new drug XB2001 is a naturally occurring antibody that potently neutralizes IL-1? and is thus a safe and promising approach to block

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FDA gives go-ahead for XBiotech’s XB2001 combo therapy in pancreatic cancer