Tiziana Life Sciences Reports Positive 3-Month Neuroimaging Scores in Multiple Sclerosis Patients Receiving Intranasal Foralumab
Tiziana Life Sciences Reports Positive 3-Month Neuroimaging Scores in Multiple Sclerosis Patients Receiving Intranasal Foralumab
NEW YORK, April 25, 2024 (GLOBE NEWSWIRE) -- 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 for the first time, quantitative data showing improvement in White Matter Z-scores measured from PET images taken at 3 months in nasal foralumab treated patients with non-active secondary progressive multiple sclerosis (na-SPMS). White Matter Z-scores are a statistical measure used in neuroimaging studies to assess the integrity or abnormalities in structures of the brain.
紐約，2024年4月25日（GLOBE NEWSWIRE）——通過新的藥物遞送途徑開發突破性免疫調節療法的生物技術公司Tiziana生命科學有限公司（納斯達克股票代碼：TLSA）（“Tiziana” 或 “公司”）今天首次公佈了定量數據，該定量數據顯示，根據經鼻福魯單抗治療的非活性患者在3個月時拍攝的PET圖像測得的白質Z分數有所改善繼發性進行性多發性硬化症（na-SPMS）。白質 Z 分數是一種統計指標，用於神經影像學研究，用於評估大腦結構的完整性或異常。
Tarun Singhal, MBBS, M.D., Director of PET Imaging Program in Neurologic Diseases at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System, and Associate Professor of Neurology at Harvard Medical School, stated, "Last week at the American Academy of Neurology annual meeting, we presented, for the first time, quantitative [F18]PBR06-PET data showing the dampening of microglial activation, an indicator of brain inflammation, in patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS) receiving intranasal foralumab. These data came from the open-label intermediate-sized patient population Expanded Access (ISPPEA) program. We calculated White Matter Z-scores to measure the effect of intranasal foralumab on microglial activation at baseline and then after foralumab treatment for three months. We saw reductions of 28% to 48%, indicating improvement in 5 out of 6 patients, and a 36% median reduction in White Matter Z-scores compared to baseline (see Figure 1). A peer-reviewed journal has published our recent work with newer [F18]PBR06-PET quantitation approaches."[1]
MBBS、醫學博士、布里格姆婦女醫院神經系統疾病 PET 成像項目主任、麻省通用布里格姆醫療系統創始成員、哈佛醫學院神經病學副教授塔倫·辛哈爾表示：“上週在美國神經病學學會年會上，我們首次公佈了顯示小膠質細胞激活減弱的 [F18] PBR06-PET 定量數據，接受鼻內注射的非活動性繼發性進行性多發性硬化症（Na-SPMs）患者腦部炎症的指標foralumab。這些數據來自開放標籤的中型患者群體擴展接入（ISPPEA）計劃。我們計算了白質 Z 分數，以衡量鼻內 foralumab 在基線和福魯單抗治療三個月後對小膠質細胞激活的影響。與基線相比，我們發現下降了28％至48％，表明6名患者中有5名有所改善，白質Z分數中位數下降了36％（見圖1）。一家經過同行評審的期刊發表了我們最近使用更新 [F18] PBR06-PET 定量方法的研究成果。”[1]
The full publication in Clinical Nuclear Medicine can be found here:
完整出版物在 臨床核醫學 可以在這裏找到：
"I am grateful for Dr. Singhal's work advancing our intranasal foralumab program and the insight his work provides into the foralumab's effect on brain inflammation. We are seeing this additional, encouraging evidence of intranasal foralumab's effect after reporting that it attenuated microglial activation in na-SPMS patients with progression independent of relapse activity (PIRA) at 3 months as evaluated by [F-18]PBR06-PET and was associated with clinical symptom improvement or stability. Based on these positive results, a double-blind, placebo-controlled, dose-ranging study (NCT06292923) of intranasal foralumab in na-SPMS with [F-18]PBR06-PET as a primary endpoint with clinical measures of EDSS (disability) and MFIS (fatigue) is currently underway. I welcome the publication of Dr. Singhal's [F18]PBR06-PET research paper, highlighting these combined findings in Clinical Nuclear Medicine," commented Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences.
“我感謝辛哈爾博士爲推進我們的鼻內福魯單抗計劃所做的工作，以及他的工作爲福魯單抗對腦部炎症的影響提供了見解。我們報告稱，經過 [F-18] PBR06-PET 評估，鼻內foralumab在3個月內減弱了進展與復發活動（PIRA）無關的NA-spms患者的小膠質細胞激活，並與臨床症狀改善或穩定性有關，因此我們看到了其他令人鼓舞的證據，證明了鼻內foralumab的作用。基於這些陽性結果，目前正在進行一項以EDSS（殘疾）和MFIS（疲勞）爲主要終點的Na-spms鼻內福魯單抗的雙盲、安慰劑對照的劑量範圍研究（NCT06292923），該研究以 [F-18] PBR06-PET 爲主要終點。我歡迎辛哈爾博士發表的 [F18] PBR06-PET 研究論文，重點介紹了這些綜合發現 臨床核醫學，” Tiziana Life Sciences董事長、代理首席執行官兼創始人加布裏埃爾·塞羅內評論道。
Figure 1*
圖 1*
*EA5 showed a worsening in their White Matter Z-Score at three months during a pseudo-exacerbation of the patient's trigeminal neuralgia.
*EA5顯示患者三叉神經痛假性惡化期間的白質Z分數在三個月時有所惡化。
About Foralumab
關於 Foralumab
Activated T cells play an essential role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial began screening patients in November 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treating neuroinflammatory and neurodegenerative human diseases.[2],[3]
活化的 T 細胞在炎症過程中起着至關重要的作用。Foralumab是唯一一種完全人源的抗CD3單克隆抗體（mAb），它與T細胞受體結合並通過調節T細胞功能來抑制炎症，從而抑制多個免疫細胞亞群中的效應器特徵。這種效果已在COVID和多發性硬化症患者以及健康的正常受試者中得到證實。非活性 SPMS 鼻內 foralumab 2 期試驗於 2023 年 11 月開始篩查患者。鼻腔抗CD3 mAb的免疫調節是治療神經炎症和神經退行性人類疾病的新途徑。[2],[3]
About Tiziana Life Sciences
關於 Tiziana 生命科學
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana's innovative nasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana's lead candidate, intranasal foralumab, the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana's technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.
Tiziana Life Sciences是一家處於臨床階段的生物製藥公司，使用變革性藥物遞送技術開發突破性療法，以實現免疫療法的替代途徑。與靜脈注射（IV）相比，Tiziana的創新鼻腔方法有可能改善療效以及安全性和耐受性。Tiziana的主要候選藥物鼻內foralumab是唯一一種完全人源化的抗CD3單抗，迄今爲止在研究中已顯示出良好的安全性特徵和對患者的臨床反應。Tiziana的免疫療法替代途徑技術已獲得專利，有幾項申請正在等待中，預計將允許廣泛的管道應用。
For further inquiries:
如需進一步查詢：
Tiziana Life Sciences Ltd
Paul Spencer, Business Development and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com
Tiziana 生命科學有限公司
保羅·斯賓塞，業務發展和投資者關係
+44 (0) 207 495 2379
電子郵件：info@tizianalifesciences.com
Investors:
Irina Koffler
LifeSci Advisors, LLC
646.970.4681
ikoffler@lifesciadvisors.com
投資者：
伊琳娜·科夫勒
LifeSci 顧問有限公司
646.970.4681
ikoffler@lifesciadvisors.com
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