NEW YORK - Tiziana Life Sciences Ltd (NASDAQ:TLSA), a biotechnology firm focused on immunomodulation therapies, announced today its invitation to apply for a grant from the ALS Association through the Hoffman ALS Clinical Trial Awards Program. The grant aims to support a clinical trial for intranasal foralumab, Tiziana's lead development candidate and a fully human anti-CD3 monoclonal antibody.
The company's invitation by the ALS Association is a nod to its ongoing efforts in developing treatments for amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease. The disease affects nerve cells in the brain and spinal cord, leading to muscle weakening and atrophy.
Tiziana's proposed trial, if funded by the grant, would involve a 6-month, dose-titration study of intranasal foralumab in 20 patients, with a focus on evaluating its effects using advanced imaging biomarkers and clinical outcome assessments.
Foralumab has shown promise in stimulating T regulatory cells and dampening inflammation when administered intranasally. The drug candidate is already being explored in a Phase 2a trial for non-active secondary progressive multiple sclerosis (NCT06292923), and the FDA has recently allowed an additional 20 patients to join an Expanded Access Program after observing disease improvement or stability in the initial 10 participants within 6 months.
The Hoffman ALS Clinical Trial Awards Program underlines the importance of early-stage clinical trials in developing new therapies. These trials are critical for determining safety, dosing, and biomarkers, which are essential for advancing investigational therapies towards FDA evaluation.
Gabriele Cerrone, Chairman and acting CEO of Tiziana Life Sciences, expressed gratitude for the invitation, emphasizing that the grant would accelerate the development of their potential therapy, potentially making a significant difference in the lives of ALS patients.
Tiziana Life Sciences continues to commit to addressing the unmet needs of patients with ALS and other debilitating diseases. The company's approach to immunotherapy through nasal administration of foralumab is patented, with several applications pending, and is expected to have broad pipeline applications.
This news is based on a press release statement from Tiziana Life Sciences.
In other recent news, Tiziana Life Sciences Ltd has been making significant strides in the development of its innovative intranasal therapy, foralumab. The biotech firm has recently filed for FDA Orphan Drug Designation for foralumab, intended for non-active secondary progressive Multiple Sclerosis (na-SPMS). If granted, this would provide the company with up to seven years of marketing exclusivity. Concurrently, a Phase 2a trial for intranasal foralumab is underway, with results expected in 2025.
The company has also reported significant findings from its ongoing research. Data presented at the American Academy of Neurology annual meeting indicated that intranasal foralumab therapy reduced brain inflammation in na-SPMS patients. Furthermore, the FDA has approved the expansion of its Expanded Access program for intranasal foralumab, now including 30 patients.
In addition to these developments, Tiziana announced positive clinical results from its Expanded Access Program for na-SPMS patients, with 70% of the participants experiencing an improvement in fatigue. These developments highlight Tiziana's commitment to advancing its research and providing potential new treatments for patients with limited options.
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