Panbela Starts Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes

 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced that it has commenced a Phase II double-blind, randomized study to evaluate CPP-1X-T (Eflornithine tablets) for recent onset type 1 diabetes, in collaboration with Indiana University School of Medicine and funded by JDRF, the leading global type 1 diabetes research and advocacy organization.

Indiana University expects to enroll 70 patients in the Phase II clinical trial at approximately 6 centers in the United States. Study eligibility will be for patients with recent onset type 1 diabetes. Participants will be randomized 2:1 to CPP-1X-T, administered orally with food, twice daily, at a 1000 mg/m2 dose, or placebo over 6 months followed by a 6 month wash out period to assess durability of response. The primary objective will be to determine the difference between the treated and placebo 2-hour Area Under the Curve (AUC)-mean using the log (mean C-peptide+1) at the 6-month end of treatment period. Secondary objectives will include C-peptide AUC, fasting and stimulated proinsulin/c-peptide ratios a biomarker of β cell stress, and the urine polyamine content at 3, 9, and 12 months timepoints.

https://finance.yahoo.com/news/panbela-starts-phase-ii-trial-140000779.html