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Tiziana Life Sciences Ltd. (NASDAQ: TLSA) is a progressive clinical-stage biotechnology company committed to developing transformative therapies targeting neurodegenerative and lung diseases. The company leverages innovative drug-delivery technologies to create novel treatments aimed at improving patient outcomes.
Key to Tiziana's portfolio are two prominent compounds: Milciclib and Foralumab. Milciclib, an inhibitor of cyclin-dependent kinases, is in Phase II clinical trials for thymic carcinoma, aiming to provide new hope for patients who have exhausted chemotherapy options. Foralumab, noted for being the only fully human-engineered anti-CD3 monoclonal antibody, is in various stages of clinical development for multiple sclerosis, autoimmune, and inflammatory diseases.
In a significant advancement, Tiziana recently reported positive clinical outcomes from its Expanded Access Program (EAP) for non-active secondary progressive multiple sclerosis (na-SPMS). Intranasal administration of Foralumab led to remarkable improvement in fatigue symptoms in 70% of patients over six months, as measured by the Modified Fatigue Impact Scale (MFIS). These results signify a groundbreaking step in addressing an unmet need in MS treatment.
The company's commitment to innovation is backed by strategic partnerships with prestigious institutions like Harvard Medical School and Brigham and Women's Hospital. Tiziana’s leadership team brings extensive experience in drug development and commercialization, ensuring a firm trajectory toward regulatory approvals and market entry.
Moreover, Tiziana’s pipeline includes potential therapies for conditions like ALS, Alzheimer's, and Crohn's Disease, underscoring its dedication to tackling a broad spectrum of debilitating conditions. The company’s forward-looking approach aims to revolutionize treatment paradigms through enhanced drug delivery systems that promise increased efficacy and reduced side effects.
With a robust clinical pipeline, strategic collaborations, and innovative technologies, Tiziana Life Sciences Ltd. remains at the forefront of biopharmaceutical research, poised to make significant strides in the field of immunomodulation therapies.
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.
Tiziana Life Sciences (NASDAQ: TLSA) announced the FDA's approval for evaluating nasal administration of Foralumab in a secondary progressive multiple sclerosis (SPMS) patient at Brigham and Women's Hospital. This marks the first nasal delivery of an antibody for SPMS. The treatment is set to commence in Q2 2021. Prior Phase 1 trials indicated Foralumab's safety for nasal administration. The company aims to address the urgent need for effective treatments in SPMS and has previously reported positive data from COVID-19 studies in Brazil.
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