BA-210 is an investigational drug that targets Rho, an intracellular GTPase important for controlling axon regeneration and repair after spinal cord injury. BA-210 has completed a Phase I/IIa clinical trial for treatment of acute spinal cord injury in 48 patients. Not only was BA-210 safe and well tolerated, but patients with cervical SCI showed very promising recovery of arm and hand movements. While current development is to treat acute spinal cord injury, BA-210 has potential to improve outcome in patients with chronic SCI, especially if used in combination with other therapies. One barrier to treating chronic SCI is the glial scar that develops and remains after SCI. Several drugs currently on the market have the potential to digest the glial scar and could be repurposed for SCI. Combining BA-210 with a repurposed drug will accelerate the regulatory path to clinical trials and approval. The overall goal of this SBIR project is to investigate the use of BA-210 in combination with one of two drugs that digest the glial scar as a treatment for chronic SCI.
Public Health Relevance Statement:
Public Health Relevance: There are 6 million Americans living with paralysis from spinal cord injury (SCI), and every year 12,000 more become permanently paralyzed. BA-210 is a Rho antagonist in clinical development to treat acute SCI; for chronic SCI, combination therapies that digest the glial scar and promote regeneration provide the best strategy to improve recovery. We propose to carry out proof-of-concept studies to test the efficacy of BA-210 in combination with drugs that digest the glial scar for the treatment of chronic spinal cord injury.
Project Terms:
Acute; Agglutinins; aggrecan; American; Animals; Antibodies; arm; Arylsulfatase B; Axon; axon regeneration; Biological Assay; Blood - brain barrier anatomy; Cervical spinal cord injury; Chondroitin ABC Lyase; Chondroitin Sulfate Proteoglycan; Chronic; Cicatrix; Clinical; Clinical Research; Clinical Treatment; Clinical Trials; collagenase; Combined Modality Therapy; Corticospinal Tracts; Development; Digestion; Dose; Drug Combinations; Drug Targeting; effective therapy; Effectiveness; efficacy testing; Enzyme-Linked Immunosorbent Assay; Enzymes; Epitopes; Evaluation; Functional disorder; functional outcomes; GAG Gene; Glial Fibrillary Acidic Protein; Goals; Guanosine Triphosphate Phosphohydrolases; Hand; Histology; Human; Immune response; immunocytochemistry; improved; Injection of therapeutic agent; injured; Investigational Drugs; Label; Lectin; Lesion; Life; Marketing; Measures; Modeling; Monitor; monocyte; mouse model; Movement; Mus; Natural regeneration; Neuraxis; Neurons; Outcome; Paralysed; Patients; Pharmaceutical Preparations; Phase; prevent; public health relevance; Pump; Quality of life; Rattus; Recovery; Recovery of Function; repaired; research study; rho; Route; Safety; scaffold; Signal Transduction; Site; Small Business Innovation Research Grant; Sodium Dodecyl Sulfate-PAGE; Spinal Cord; Spinal cord injury; Staining method; Stains; System; Temperature; Testing; Topical application; Wisteria
