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Tiziana Life Sciences Ltd. develops intranasal foralumab, a fully human anti-CD3 monoclonal antibody, as a clinical-stage biotechnology company focused on neuroinflammatory and neurodegenerative diseases. News for TLSA centers on clinical and preclinical data for intranasal anti-CD3 therapy, including non-active secondary progressive multiple sclerosis, Multiple System Atrophy, Alzheimer’s disease, ALS, Long COVID-associated neuroinflammation, and age-related cognitive decline.
Company updates also cover biomarker work involving CSF proteomics, TSPO-PET and microglial activation, peer-reviewed publications, scientific conference presentations, expanded-access observations, and financing actions such as registered direct offerings of ordinary shares and warrants.
Tiziana Life Sciences (NASDAQ: TLSA) has received FDA Fast Track designation for its intranasal foralumab, a fully human anti-CD3 monoclonal antibody, to treat non-active Secondary Progressive Multiple Sclerosis (na-SPMS). This designation expedites the review process and increases FDA interaction. Intranasal foralumab aims to modulate the immune system and reduce neuroinflammation in neurodegenerative diseases.
The company is currently conducting a Phase 2a trial for na-SPMS and has an Expanded Access Program showing promising results. However, Tiziana faces a potential Nasdaq delisting due to not maintaining a minimum bid price of $1.00. The company plans to appeal this decision and present its compliance plan to the Nasdaq Hearings Panel.
Tiziana Life Sciences (Nasdaq: TLSA) has secured $3.4 million in non-dilutive funding. This funding will support their ongoing Phase 2 trial for intranasal foralumab in treating non-active secondary progressive multiple sclerosis (na-SPMS) and advancements in Alzheimer's Disease research. Chairman and acting CEO, Gabriele Cerrone, emphasized the importance of this funding in propelling their research and expressed their intention to seek further non-dilutive funding.
Tiziana Life Sciences (Nasdaq: TLSA) announced that the FDA has granted approval for the use of intranasal foralumab in treating a patient with moderate Alzheimer's disease under an Expanded Access IND. This pathway allows patients with serious conditions, lacking other therapy options, to access investigational drugs. Dr. Howard L. Weiner, Principal Investigator and Chairman of Tiziana’s Scientific Advisory Board, expressed optimism about the potential of nasal foralumab to slow cognitive decline, citing its effectiveness in reducing microglial inflammation in progressive MS patients. The company plans to closely monitor treatment responses while preparing for a Phase 2 study targeting early symptomatic Alzheimer’s disease. Gabriele Cerrone, Chairman and acting CEO, emphasized the groundbreaking potential of foralumab in addressing neuroinflammation caused by toxic protein accumulation in the brain.
Tiziana Life Sciences (Nasdaq: TLSA) announced that the FDA has accepted its submission for Fast Track Designation for its intranasal foralumab treatment for non-active, secondary-progressive multiple sclerosis (na-SPMS). Foralumab is a fully human anti-CD3 monoclonal antibody designed to induce T regulatory cells. In an Intermediate-Sized Patient Population Expanded Access program, 70% of the ten dosed patients demonstrated a clinically meaningful reduction in fatigue, with disease stability observed over six months. The Fast Track submission included data from both animal models and clinical experience. If granted, this designation could expedite FDA review processes, which is significant given the lack of approved therapies for na-SPMS. Chairman and acting CEO Gabriele Cerrone highlighted the potential of Fast Track Designation to enhance development through increased FDA interaction and partnership.
Tiziana Life Sciences (NASDAQ: TLSA) reported a 80% qualitative improvement in PET imaging for non-active Secondary Progressive Multiple Sclerosis (na-SPMS) patients receiving intranasal foralumab for at least six months. The FDA has permitted the enrollment of an additional 20 patients in the Expanded Access Program (EA), aiming to gather more data and analyze for further insights. The company also applied for FDA Orphan Drug Designation for foralumab to treat na-SPMS. This development is a significant milestone for Tiziana's immunomodulation therapies, as stated by Gabriele Cerrone, the acting CEO and founder.
Tiziana Life Sciences (Nasdaq: TLSA), a biotechnology company, has applied for a grant from the ALS Association to fund a clinical trial for intranasal foralumab, an anti-CD3 monoclonal antibody. The grant is part of the Hoffman ALS Clinical Trial Awards Program. The trial aims to evaluate the safety, dosing, and biomarkers of foralumab in ALS patients using cutting-edge imaging techniques like PET scans. Previously, foralumab showed promising results in an Expanded Access Program for non-active secondary progressive multiple sclerosis. The company hopes the grant will support a 6-month trial involving 20 participants, advancing their efforts to develop effective ALS treatments.
Tiziana Life Sciences announced that Dr. Howard L. Weiner, its Scientific Advisory Board Chairman, will receive the 'Giants of MS' award for his contributions to multiple sclerosis (MS) research.
The award will be presented at the Consortium of Multiple Sclerosis Centers annual meeting on May 30, 2024.
Dr. Weiner is celebrated for his work on innovative treatments like intranasal foralumab, which shows promise in improving the lives of MS patients.
Foralumab has shown positive results in an Expanded Access Program, with 70% of patients experiencing improved fatigue.
The drug is also undergoing a Phase 2a trial, with data expected in 2025.
Tiziana Life Sciences, a biotechnology company, files for Orphan Drug Designation for intranasal foralumab for treating non-active secondary progressive Multiple Sclerosis, aiming to be the first therapy to receive this designation. Supported by clinical evidence, the drug has shown positive results in an Expanded Access Program, improving fatigue in 70% of patients. A Phase 2a trial is ongoing, with a data readout expected in 2025. Orphan Drug Designation brings significant benefits if approved.
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