Caladrius Biosciences Reports Top-Line Data for the Phase 2a Sanford Project: T-Rex Trial of CLBS03 for Recent Onset Type 1 Diabetes
Caladrius Biosciences, Inc. (CLBS)
Last caladrius biosciences, inc. earnings: 11/6 04:05 pm
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Source: GlobeNewswire
BASKING RIDGE, N.J., Feb. 13, 2019 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), a late-stage therapeutics development biopharmaceutical company with multiple development programs targeting select cardiovascular indications and autoimmune disease, today announced top-line results from The Sanford Project: T-Rex Study, a prospective, randomized, placebo-controlled, double-blind Phase 2a clinical trial of 110 subjects to evaluate the safety and efficacy of the Company’s CLBS03 as a treatment for recent-onset type 1 diabetes (“T1D”) in adolescents. The initial analysis of the 1-year follow-up data for all subjects shows that CLBS03 was well tolerated at the doses tested in the study (targeting 2.5 million cells/kg or 20 million cells/kg); however, no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at 1 year was observed at the group level (using the standard mixed meal tolerance test). As with many
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