Tiziana Life Sciences Seeks ALS Association Grant for Foralumab Trial

Tiziana Life Sciences, Ltd. (Nasdaq: TLSA), a biotechnology firm focused on pioneering immunomodulation therapies, has been invited to apply for a prestigious grant from the ALS Association. This grant opportunity is part of the Hoffman ALS Clinical Trial Awards Program, which aims to fund innovative clinical trials for Amyotrophic Lateral Sclerosis (ALS). The initiative is spearheaded by Dr. James Berry and Dr. Suma Babu from the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital.

Tiziana's leading therapeutic candidate, intranasal foralumab, is a fully human anti-CD3 monoclonal antibody designed to stimulate T regulatory cells when administered through the nasal route. This treatment has shown promising results in an intermediate-sized Expanded Access (EA) Program involving 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS). All participants either exhibited disease stability or improvement within a six-month period. Based on these encouraging outcomes, the FDA has approved the enrollment of an additional 20 patients in the EA program. The therapy is also undergoing a Phase 2a trial that is randomized, double-blind, placebo-controlled, and multicenter, aiming to evaluate its efficacy in na-SPMS patients.

The Hoffman ALS Clinical Trial Awards Program aims to advance potential ALS therapies by supporting early-stage clinical trials. These trials are crucial for collecting data on safety, dosing, and biomarkers, thereby aiding in the transition of experimental therapies to FDA evaluation. Successful early-stage trials also reduce the risk for subsequent large-scale clinical trials and help secure additional funding necessary for further research.

Dr. Berry highlighted the study's goal, which is to give ALS patients a chance to participate in a six-month, dose-titration trial of intranasal foralumab. Dr. Babu added that the study would employ advanced imaging biomarkers, such as positron emission tomography (PET), along with key clinical evaluations to assess the therapy's effectiveness.

ALS, commonly known as Lou Gehrig's disease, progressively deteriorates nerve cells in the brain and spinal cord, leading to muscle weakening. The disease is considered an Orphan Disease due to its sporadic nature and unknown risk factors. Given the limited treatment options for ALS, Tiziana Life Sciences is dedicated to developing innovative therapies targeting the disease's root causes.

Gabriele Cerrone, Chairman, acting CEO, and founder of Tiziana Life Sciences, expressed his gratitude for the invitation to apply for the grant. He emphasized that this opportunity underscores the recognition of Tiziana's commitment to scientific innovation and improved patient outcomes. The grant, if awarded, will support a clinical trial involving 20 patients, focusing on the evaluation of intranasal foralumab. Cerrone stated, "We are deeply honored to be invited by the ALS Association to apply for this grant. This funding would allow us to advance our clinical program and accelerate the development of our potential therapy that could make a meaningful difference in the lives of ALS patients."

Tiziana Life Sciences remains dedicated to advancing research and development aimed at addressing the unmet needs of patients with ALS and other debilitating diseases. The company looks forward to potentially collaborating with the ALS Association to bring new hope to those affected by this devastating condition.

Foralumab functions by binding to the T cell receptor and modulating T cell activity, thereby reducing inflammation. This mechanism has shown efficacy in patients with COVID-19, multiple sclerosis, and healthy subjects. The Phase 2 trial for non-active SPMS, involving intranasal administration of foralumab, began patient screening in November 2023.

Tiziana Life Sciences focuses on developing advanced therapies using innovative drug delivery technologies to offer improved efficacy and safety compared to traditional intravenous methods. The company’s lead candidate, intranasal foralumab, has demonstrated a favorable safety and efficacy profile in clinical studies. Tiziana holds several patents for its technology, with broad applications expected across various therapeutic areas.

Massachusetts General Hospital (MGH), founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute manages the largest hospital-based research program in the U.S., with over 9,500 researchers and more than $1 billion in annual research operations. MGH is a founding member of the Mass General Brigham healthcare system.