Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that its grant application to the ALS Association has been approved.
The company has secured funding under the Hoffman ALS Clinical Trial Awards Program which will be used for a 20-patient study investigating the safety and early efficacy of its investigational drug intranasal foralumab in patients with Amyotrophic Lateral Sclerosis (ALS), a progressive neurodegenerative disease.
Researchers will be using PET imaging to detect neuroinflammation, hoping to replicate the previous positive findings achieved with the PET imaging approach Tiziana has seen in studies of patients with multiple sclerosis.
Intranasal foralumab, a fully human anti-CD3 monoclonal antibody, has demonstrated the ability to stimulate T regulatory cells and showed disease improvement or stability within six months in an Expanded Access Program for 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS).
The Food and Drug Administration has approved expanding this program to include 20 additional patients, while foralumab is also being evaluated in an ongoing Phase 2a clinical trial for na-SPMS.
"We are honoured to receive this prestigious grant from the ALS Association, which underscores the promising potential of our therapeutic platform in addressing the urgent needs of ALS patients,” Tiziana CEO Ivor Elrifi said in a statement.
“Tiziana Life Sciences’ innovative approach targets the underlying mechanisms of ALS with the aim of halting or slowing disease progression.”
He added: “The company’s commitment to rigorous scientific research and patient-centric innovation aligns with the ALS Association’s mission to discover treatments and a cure for ALS, as well as to serve, advocate for, and empower people affected by ALS.”