- The French authority has signed off XBiotech Inc's (NASDAQ:XBIT) multicenter randomized clinical study for Natrunix combined with trifluridine/tipiracil for colorectal cancer.
- The French National Cancer Institute (INCA) has also awarded a grant to fund all clinical costs for the study.
- Investigators will combine Natrunix and trifluridine/tipiracil as a new candidate therapy for metastatic colorectal cancer in subjects that have failed earlier treatment with oxaliplatin, irinotecan, and fluoropyrimidine.
- The study will randomize patients to receive the Natrunix plus chemotherapy or placebo plus chemotherapy and is designed to seamlessly proceed to a Phase 3 study based on the achievement of certain early efficacy milestones.
- The clinical program will include over 20 participating clinical centers and enroll at least 160 subjects.
- The main objective of the phase 2 study is to evaluate the efficacy of Natrunix + trifluridine/tipiracil in comparison with placebo + trifluridine/tipiracil for 6-month overall survival in patients with refractory metastatic colorectal cancer.
- Secondary efficacy measures will include progression-free survival, median overall survival, tolerance, quality of life, serum markers of inflammatory cytokines, and tumor markers.
- Price Action: XBIT shares are up 24% at $9 during the market session on the last check Thursday.
