clinical trial

[Statera Biopharma, Inc.] Statera Biopharma, Inc. announced that it has received Central Institutional Review Board approval to conduct a Phase III clinical trial for STAT-201 in the treatment of pediatric Crohn’s Disease, a chronic relapsing inflammatory condition of the gastrointestinal tract.

[IMAC Holdings, Inc.] IMAC Holdings, Inc. announced that it has completed the second cohort of its Phase I clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinson’s disease.

[Axcella Therapeutics] Axcella Therapeutics announced that the US FDA has granted a Fast Track Designation to AXA1125 for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis.

[IVERIC Bio, Inc.] IVERIC Bio, Inc. announced a post-hoc analysis which evaluated various Geographic Atrophy (GA) growth parameters to explore the rate of disease progression within various regions in the fovea in a subset of patients from the GATHER1 Zimura® Phase III clinical trial for the treatment of GA.

[enGene Inc.] enGene Inc. announced positive results from its LEGEND study, a first-in-human Phase I/II clinical trial of EG-70 for the treatment of high-grade non-muscle Invasive bladder cancer in patients with carcinoma in situ that are BCG-unresponsive.

[Nature] The authors presented the clinical experience from the first four patients with H3K27M-mutant diffuse intrinsic pontine glioma/diffuse midline glioma treated with GD2-CAR T cells at dose level 1.