NEW YORK, June 26, 2024 – Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the U.S. Food and Drug Administration (FDA) has allowed intranasal foralumab to be used under an Expanded Access (EA) IND in its first patient with moderate Alzheimer’s disease.

2024年6月26日，纽约——Tiziana Life Sciences，Ltd.（纳斯达克：TLSA）（“Tiziana”或“公司”）是一家通过新型药物输送途径开发突破性免疫调节疗法的生物技术公司，今天宣布，美国食品和药物管理局（FDA）已允许在其首例中度阿尔茨海默病患者的扩大获取（EA）IND下使用鼻内foralumab。

Expanded access IND’s provide a pathway for patients to gain access to investigational drugs, biologics, and medical devices used to diagnose, monitor, or treat patients with serious diseases or conditions for which there are no comparable or satisfactory therapy options available outside of clinical trials.Howard L.

扩大访问IND为患者提供了一条途径，使其能够获得用于诊断，监测或治疗严重疾病或病症的研究药物，生物制剂和医疗设备，这些疾病或病症在临床试验之外没有可比或令人满意的治疗选择。霍华德L。

Weiner, M.D., Principal Investigator, Chairman of Tiziana’s Scientific Advisory Board and co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital, a founding member of Mass General Brigham healthcare system stated, “I am excited to treat this first patient with moderate AD with nasal foralumab as early as July.

首席研究员、蒂齐亚纳科学顾问委员会主席、布里格姆妇女医院安·罗姆尼神经系统疾病中心联合主任、马萨诸塞州布里格姆将军医疗保健系统的创始成员韦纳医学博士表示：“我很高兴最早在7月用鼻孔单抗治疗这第一例中度AD患者。

These patients have no other treatment options including newly approved anti-amyloid drugs and continue to deteriorate. Given that nasal foralumab dampens microglial inflammation in subjects with advanced progressive MS and microglial activation is a prominent feature of Alzheimer’s disease, Tiziana is hopeful that nasal foralumab will help slow the progression of cognitive decline in this first patient.

这些患者没有其他治疗选择，包括新批准的抗淀粉样蛋白药物，并继续恶化。鉴于鼻孔单抗可以抑制晚期进行性MS患者的小胶质细胞炎症，小胶质细胞激活是阿尔茨海默病的一个突出特征，Tiziana希望鼻孔单抗可以帮助减缓第一位患者认知能力下降的进展。

We will work closely with FDA to evaluate the treatment responses in this patient with moderate AD while we initiate our Phase 2 study Alzheimer’s Disease in patients with early symptomatic disease.”Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences commented, “In addition to our previousl.

我们将与FDA密切合作，评估这名中度AD患者的治疗反应，同时启动针对早期症状性疾病患者的阿尔茨海默病的2期研究。”Tiziana Life Sciences董事长、代理首席执行官兼创始人加布里埃尔·塞隆（GabrieleCerrone）评论道：“除了我们之前的研究。