Caladrius reports interim Phase II data for Type I diabetes candidate

Caladrius Biosciences Inc. (NASDAQ:CLBS) said recent-onset Type I diabetes candidate CLBS03 was "non-futile as determined by predefined futility criteria for therapeutic effect" in an interim analysis of 55 evaluable patients ages 8-17 in the Phase II T-Rex trial. The company declined to disclose details or the criteria for futility, but said the analysis was triggered by 50% of the total number of patients in the trial completing six months of follow-up. CLBS03 was well tolerated.

The primary endpoint of the double-blind, placebo-controlled, U.S. trial is Mixed Meal Tolerance Test (MMTT)-stimulated C-peptide area under the curve (AUC) over 52 weeks. Secondary endpoints include MMTT-stimulated C-peptide AUC over 104 weeks, HbA1c, insulin usage, severe hypoglycemic episodes and safety...