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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 (TLSA) has received FDA approval to expand its Intermediate-Size Patient Population Access program for its intranasal foralumab treatment in secondary progressive multiple sclerosis (SPMS). Following promising clinical responses from two patients, Tiziana aims to initiate treatment for eight additional patients. The dosing regimen will remain at 50 mcg three times a week, with the potential for dose escalation. The study is expected to begin in July 2022, focusing on safety, tolerability, and clinical benefits.
Tiziana Life Sciences (NASDAQ: TLSA) has initiated a Phase 1b clinical trial for foralumab, an oral immunotherapy for mild-to-moderate Crohn's Disease (CD). This trial, expected to conclude by Q4 2022, aims to evaluate the safety and tolerability of a new enteric-coated capsule formulation. The study will also assess clinical responses and pharmacokinetics. Foralumab represents a significant departure from traditional intravenous or subcutaneous therapies, potentially offering improved patient compliance and fewer side effects.
Tiziana Life Sciences (Nasdaq: TLSA) announces the replay availability of its March 14 KOL event, "Foralumab Clinical Update in Multiple Sclerosis," along with presentation slides on its website. Zacks released a research note discussing positive clinical data for a SPMS patient treated for six months. Tiziana is focused on innovative immunotherapy approaches, including intranasal foralumab and milciclib, which have shown favorable safety profiles in studies. The company is advancing transformational drug delivery technologies aimed at improving efficacy and safety.
Tiziana Life Sciences (Nasdaq: TLSA) announced a virtual Key Opinion Leader webinar scheduled for March 14, 2022, focusing on the clinical updates of foralumab in multiple sclerosis. Renowned experts, including Prof. Howard Weiner from Harvard, will discuss the significance of intranasal immunotherapy for neurodegenerative diseases. The event aims to detail recent clinical data where patients with Secondary Progressive Multiple Sclerosis were treated with foralumab. Attendees can register online and submit questions to the panel.
Tiziana Life Sciences (Nasdaq: TLSA) announced positive results from a six-month clinical trial of intranasal foralumab in a patient with Secondary Progressive Multiple Sclerosis (SPMS). The treatment was well-tolerated with no adverse reactions. Significant biological improvements included sustained inhibition of microglial activation and reduction of pro-inflammatory cytokines. The FDA authorized a second patient to receive therapy under an Expanded Access IND. A Key Opinion Leader (KOL) event will be held on March 14, 2022, to discuss findings.
Tiziana Life Sciences Ltd. (Nasdaq: TLSA) announced that its former subsidiary, AccuStem Sciences, published new data demonstrating that StemPrintER is a strong prognostic tool for distant recurrence risk in breast cancer. Analyzing 776 tumor samples from the TransATAC cohort showed that patients with a low StemPrintER Risk Score had a 5.8% risk of distant recurrence at 10 years, compared to 23.2% for high scores. This indicates StemPrintER's potential in clinical decision-making, alongside established tests.
Tiziana Life Sciences Ltd (Nasdaq: TLSA) has announced that CEO Dr. Kunwar Shailubhai will present at the 2022 BIO CEO & Investor Conference on February 14-15 in New York City. The company is pioneering novel immunotherapy delivery methods, focusing on its lead product, foralumab, an entirely human antibody. Recent studies suggest that nasally administered foralumab can effectively immunomodulate in COVID-19 patients and has shown promise for treating multiple sclerosis and inflammatory bowel diseases. Interim results will be shared in Q1 2022.
Tiziana Life Sciences Ltd (Nasdaq: TLSA) announced an amendment to its Investigational New Drug (IND) application for the oral formulation of foralumab, aimed at patients with mild-to-moderately active Crohn’s Disease. This would mark the first oral immunotherapy for this condition. If accepted by the FDA, Tiziana anticipates completing the Phase 1b clinical study by Q4 2022. The trial's primary focus is on safety, with a secondary assessment of pharmacodynamics. The amendment allows for a broader patient population and a shorter dosing regimen, addressing prior challenges in patient enrollment.
Tiziana Life Sciences Ltd (NASDAQ: TLSA) announced its CEO and Chief Scientific Officer, Kunwar Shailubhai, Ph.D., will participate in a virtual fireside chat at the B. Riley Securities 2022 Oncology Conference on January 27, 2022, at 4:00 p.m. EDT. The discussion will provide company updates focusing on breakthrough therapies for KRAS+ Non-Small Cell Lung Cancer and innovative drug delivery technologies. Tiziana's leading candidates include intranasal foralumab and milciclib, both showing favorable safety profiles and clinical responses in studies.
Tiziana Life Sciences (Nasdaq: TLSA) has announced a stock repurchase program authorized by its Board of Directors, allowing for the buyback of up to $5 million of the Company's common shares. This program is effective until December 31, 2022, and will utilize the Company's working capital. Executive Chairman Gabriele Cerrone expressed confidence in Tiziana’s growth opportunities, deeming the buyback an attractive use of capital, supported by a strong balance sheet. Tiziana develops innovative therapies through novel drug delivery methods that may enhance efficacy and safety.