CASE STUDY #1 IN CIPN HUMAN SUBJECT WITH PANCREATIC CANCER
Stage 1B Pancreatic Cancer
FOLFOXIRI Chemo Regimen—5-FU, folinic acid, irinotecan, and (60%) oxaliplatin
7 cycles of FOLFOXIRI (14 weeks) prior to CFB-001 gel treatment, 5 cycles of chemo with CFB-001 topical treatment
Severe 9/10 CIPN symptoms for 7 cycles (~14 weeks) despite gabapentin treatment
Severe shooting pain, tingling, numbness in hands and feet. Unable to sleep at night. Wearing gloves
at all times. Very difficult to function.
Large reduction in CIPN symptoms with CFB-001 0.5% 2x/day at ~ Cycle 7. Improvement in symptoms through Cycle 9 allowed treating oncologist to increase Oxaliplatin dose.
Increased Oxaliplatin dose caused breakthrough CIPN symptoms by Cycle 10. CFB-001 gel increased to 1.0% gel/ 4x day to again control symptoms to completion.