clinical trial

[Cedars-Sinai] Cedars-Sinai has been awarded $11.99 million by California's stem cell agency to launch a clinical trial testing a potential gene and stem cell therapy for amyotrophic lateral sclerosis (ALS).

[Terns Pharmaceuticals, Inc.] Terns Pharmaceuticals, Inc. announced the initiation of patient dosing in the AVIATION Trial, a Phase Ib clinical trial evaluating TERN-201, an orally-administered, highly selective inhibitor of vascular adhesion protein-1 (VAP-1) in patients with NASH.

[American Journal of Physiology-Gastrointestinal and Liver Physiology] The authors outline the critical areas and challenges that must be addressed when transitioning laboratory-based discovery of intestinal organoids, through an investigational new drug application to first-in-human clinical trial, and encourage investigators to consider the required regulatory steps from the earliest stage of the translational process.

[Vita Therapeutics] Vita Therapeutics announced the completion of an oversubscribed $32 million Series A. Vita’s lead therapy, VTA-100, is currently undergoing studies for the treatment of limb-girdle muscular dystrophy. It is designed to be an autologous treatment that combines gene correction and iPSC technology to help repair and replace muscle cells.

[BioCardia, Inc.] BioCardia®, Inc. announced that the independent Data Safety Monitoring Board has completed its prespecified data review for the Phase III pivotal CardiAMP™ Cell Therapy Heart Failure Trial. CardiAMP cell therapy uses a patient’s autologous bone marrow cells delivered to the heart in a minimally-invasive procedure.

[Journal of Clinical Oncology] Investigators conducted a pilot clinical trial of a humanized CD19 CAR T-cell product in children and young adults with relapsed or refractory B-cell acute lymphoblastic leukemia or B-lymphoblastic lymphoma, treated in two cohorts: with or without prior CAR exposure.