Caladrius says no improvement in primary endpoint in T-Rex study results
Caladrius (CLBS) 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, or T1D, in adolescents.
The initial analysis of the one-year follow-up data for all subjects shows that CLBS03 was well tolerated at the doses tested in the study, however, no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at one year was observed at the group level.
As with many Phase 2a trials, the database from this study is large and the analysis and interpretation of all the information will require several months of intensive evaluation and will be critical to the decision regarding the next steps in development of CLBS03.
In addition, the data from the 2-year follow-up, once complete, will afford supplemental information and are necessary to complete the evaluation of this therapy.
Type 1 diabetes, once known as juvenile diabetes or insulin-dependent diabetes, is a chronic condition in which the pancreas produces little or no insulin. Insulin is a hormone needed to allow sugar (glucose) to enter cells to produce energy.
Different factors, including genetics and some viruses, may contribute to type 1 diabetes. Although type 1 diabetes usually appears during childhood or adolescence, it can develop in adults.
Despite active research, type 1 diabetes has no cure. Treatment focuses on managing blood sugar levels with insulin, diet and lifestyle to prevent complications.
CLBS is down $1.26 to $4.08.
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