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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 entered into an agreement with FHI Clinical to conduct a Phase 2 proof-of-concept study in Brazil, evaluating the safety and efficacy of intranasal Foralumab for severe COVID-19 patients. This randomized, placebo-controlled trial aims to build on earlier findings in non-hospitalized patients. It will involve up to 80 participants with pulmonary inflammation, assessing various health metrics after 14 days of treatment. This pivotal study is expected to enhance the understanding of Foralumab's potential in treating COVID-19-related complications.
Tiziana Life Sciences has appointed Dr. Kevin Schutz as Vice-President of Regulatory Affairs, strengthening its global development capabilities. Dr. Schutz, with over 19 years in the pharmaceutical sector, will manage regulatory interactions for clinical studies across the U.S., Europe, and Asia. His expertise includes working with regulatory agencies such as the FDA and EMA, essential for the company’s clinical pursuits. Tiziana focuses on innovative treatments for diseases like multiple sclerosis and COVID-19, with its lead candidate, Foralumab, showing promise for various indications.
Tiziana Life Sciences (NASDAQ: TLSA) has submitted a grant proposal to the UK COVID Therapeutics Advisory Panel to advance the clinical development of Foralumab, an innovative nasal treatment for non-hospitalized COVID-19 patients. This initiative aligns with the UK government's call for at-home therapies. Previous studies in Brazil showed that Foralumab effectively reduced lung inflammation in COVID-19 patients. Additionally, a separate clinical trial for hospitalized patients is in the works. Foralumab could potentially address various COVID-19 variants, enhancing treatment options.
Tiziana Life Sciences has announced that its Notice of Annual General Meeting (AGM) is now available on its website. The AGM is scheduled for June 25, 2021, at 10:00 am BST and will be conducted electronically due to ongoing Covid-19 restrictions. Shareholders are encouraged to submit their proxy votes and any questions in advance to facilitate the meeting. Full details of the AGM procedures are outlined in the Notice of AGM.
Tiziana Life Sciences (NASDAQ: TLSA) announced positive results from its Phase 1 trial of nasally administered Foralumab, showing significant immunomodulatory effects. Conducted at Brigham and Women’s Hospital, the study demonstrated that a 50 mcg/day dose led to favorable changes in cytotoxic T-cell subsets and inflammatory biomarkers without severe toxicity. These findings support further clinical development, primarily targeting progressive MS. Tiziana's innovative approach may enhance treatment outcomes for neurodegenerative diseases.
Tiziana Life Sciences (NASDAQ: TLSA) announced the dosing of the first patient with secondary progressive multiple sclerosis (SPMS) with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody. The study, conducted at Brigham and Women’s Hospital, focuses on evaluating the treatment's safety, tolerability, and neurological responses over six months. Previous studies indicated Foralumab's well-tolerated nature and strong anti-inflammatory effects, with results showing no significant adverse events. The trial aims to address the urgent need for effective SPMS treatments.
Tiziana Life Sciences plc (NASDAQ: TLSA, LSE: TILS) announces an interview with CEO Dr. Kunwar Shailubhai, set to air on The RedChip Money Report on May 8, 2021, at 7 p.m. local time. The program reaches approximately 73 million homes via Bloomberg Television. Tiziana focuses on novel therapies in oncology and immunology, with key developments including Foralumab, a unique anti-CD3 monoclonal antibody, and an anti-IL6R monoclonal antibody targeting COVID-19 related inflammation. Caution is advised regarding forward-looking statements.
Tiziana Life Sciences (TLSA) announced a partnership with Takanawa Japan K.K. to find a clinical partner for Milciclib, aimed at treating advanced hepatocellular carcinoma (HCC) in Asia. Milciclib has shown positive results in phase 1 and phase 2 trials, demonstrating tolerability in sorafenib-resistant patients. The partnership focuses on addressing the high prevalence of HCC in Asian countries where treatment options are limited. A recent patent was granted for Milciclib's use in combination therapies, enhancing its development prospects.
Tiziana Life Sciences announced that its CEO Dr. Kunwar Shailubhai and Dr. Howard Weiner will participate in a fireside chat on April 28, 2021, at 10:30 a.m. EDT. The video link session will provide updates on the company's progress, focusing on its innovative therapeutics for oncology and inflammation. Topics will include development efforts for Foralumab and anti-IL6R monoclonal antibodies. No new information will be shared, only data already available publicly. Tiziana is known for its work in treating autoimmune and inflammatory diseases.
On April 13, 2021, Tiziana Life Sciences plc (NASDAQ:TLSA) announced plans for its former subsidiary, Accustem Sciences, to apply for a Nasdaq listing following the distribution of shares to Tiziana's shareholders. The board believes this move aligns better with Accustem's business. Accustem's StemPrintER assay predicts the recurrence risk in R+/HER2- breast cancer patients and has shown superior prognostic capabilities over Oncotype DX. This test aims to refine treatment approaches, helping to identify patients at heightened risk for metastasis.