{"id":686808,"date":"2022-09-20T06:37:26","date_gmt":"2022-09-20T10:37:26","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\/"},"modified":"2022-09-20T06:37:26","modified_gmt":"2022-09-20T10:37:26","slug":"tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\/","title":{"rendered":"Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li>\n          <strong>The second Expanded Access patient (EA2) demonstrated improved walking as measured by gait stability and endurance<\/strong>\n        <\/li>\n<li>\n          <strong>The patient showed clinically significant improvement in the Expanded Disability Status Scale (EDSS).<\/strong>\n        <\/li>\n<li>\n          <strong>The 6-month PET imaging will occur in Q4 2022 to confirm simultaneous improvements in microglial activation<\/strong><br \/>\n          \n        <\/li>\n<\/ul>\n<p>NEW YORK, Sept.  20, 2022  (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the second patient (\u201cEA2\u201d) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard clinical assessment.<\/p>\n<p>On September 12th, 2022, this patient had walked 100 meters without a cane or need for rest. Prior to this, on June 8, 2022, the patient required a cane to walk 100 meters. This corresponds with a clinically meaningful improvement in the EDSS score of 0.5. The patient\u2019s pyramidal score remained stable and did not worsen over time. This patient has received a total of 10.5 treatment cycles of foralumab to date.<\/p>\n<p>\u201cCoupled with our PET imaging data demonstrating inhibition of microglial activation, I am truly excited and encouraged by the clinical benefits shown so far for the first two expanded access patients receiving intranasal foralumab for SPMS,\u201d commented Gabriele Cerrone, Executive Chairman and interim Chief Executive Officer of Tiziana. \u201cThis program is a top priority for us, and we expect to enroll four additional patients with SPMS at Brigham and Women\u2019s Hospital (BWH) in Q4 2022.\u201d<\/p>\n<p>Howard L. Weiner, M.D., Co-Director of the\u00a0Ann Romney Center for Neurologic Diseases\u00a0at BWH and Chairman of Tiziana&#8217;s\u00a0Scientific Advisory Board, stated, \u201cI am pleased, but not surprised to see additional clinical improvement in the second patient. SPMS represents an advanced stage of multiple sclerosis with few treatment options and creates a severe burden on patients.\u201d<\/p>\n<p>Dr.\u00a0Tanuja Chitnis, M.D., Professor of Neurology and the Principal investigator of the clinical study at BWH said, \u201cPatients with non-active SPMS normally do not improve over a six-month time course. I am very encouraged by these results and look forward to seeing this patient\u2019s PET imaging to determine if there is a continued reduction in microglial activation to correlate with the improvement we are observing in the patient\u2019s clinical exam.\u201d<\/p>\n<p>\n        <strong>About Foralumab<\/strong>\n      <\/p>\n<p>Foralumab (formerly NI-0401), the only entirely human anti-CD3 mAb, has shown reduced release of cytokines after IV administration in healthy volunteers and in patients with Crohn&#8217;s disease. In a humanized mouse model (NOD\/SCID IL2\u03b3c-\/-), it was shown that while targeting the T-cell receptor, orally administered foralumab modulates immune responses of the T-cells and enhances regulatory T-cells (Tregs), thereby providing therapeutic benefit in treating inflammatory and autoimmune diseases without the occurrence of potential adverse events usually associated with parenteral mAb therapy. Once a day treatment for 10 consecutive days with intranasal foralumab was both well tolerated and produced clinical responses in COVID-19 patients. Based on these studies, the intranasal and oral administration of Foralumab offers the potential to become a well-tolerated immunotherapy for autoimmune and inflammatory diseases by the induction of Tregs.<\/p>\n<p>\n        <strong>About\u00a0Tiziana Life Sciences<\/strong>\n      <\/p>\n<p>Tiziana Life Sciences\u00a0is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana\u2019s innovative nasal, oral and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana\u2019s two lead candidates, intranasal foralumab, the only fully human anti-CD3 mAb, and milciclib, a pan-CDK inhibitor, have both demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana\u2019s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.<\/p>\n<p>For further inquiries:<\/p>\n<p>\n        <strong>Tiziana Life Sciences Ltd<\/strong>\n      <\/p>\n<p>Hana Malik, Business Development and Investor Relations Manager<br \/>+44 (0) 207 495 2379<br \/>email:\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=kIDnBca2hToJXL4i-rpBhKCm9yfW7M0kJyS0ogCiOaQaNEAMPang5yS8x-LgP2Qcg4L_Kz3v7hMeZ71LV3mUkL93r_KETTItToi_Tga7pV68orGsT5y-icmkDx07asIK\" rel=\"nofollow noopener\" target=\"_blank\"><u>info@tizianalifesciences.com<\/u><\/a><\/p>\n<p>\n        <strong>Investors:<\/strong><br \/>\n        <br \/>Irina Koffler<br \/>LifeSci Advisors, LLC<br \/>646.970.4681<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=cxkMKP9ibyxOJ41cbP931bsQEMoECFqzJXbcI81Dy8Sw3qyt8uhanQnf4pl_jnJPt_OMUJOX2WKyiif9J9IPPGjN_hS_fP602arkW7tlY61ZkBflxDNP2bMKsRDC_PXL\" rel=\"nofollow noopener\" target=\"_blank\"><u>ikoffler@lifesciadvisors.com<\/u><\/a><\/p>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODY0OTgyNCM1MTYxODc1IzIxMjM4ODU=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/NTQ5MzQwYTUtOGFmMC00OGUzLTk0YWQtYTExZjIzY2YyYjhiLTExMzU0NTY=\/tiny\/Tiziana-Life-Sciences-Plc.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>The second Expanded Access patient (EA2) demonstrated improved walking as measured by gait stability and endurance The patient showed clinically significant improvement in the Expanded Disability Status Scale (EDSS). The 6-month PET imaging will occur in Q4 2022 to confirm simultaneous improvements in microglial activation NEW YORK, Sept. 20, 2022 (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the second patient (\u201cEA2\u201d) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard clinical assessment. On September 12th, 2022, this patient had walked 100 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-686808","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"The second Expanded Access patient (EA2) demonstrated improved walking as measured by gait stability and endurance The patient showed clinically significant improvement in the Expanded Disability Status Scale (EDSS). The 6-month PET imaging will occur in Q4 2022 to confirm simultaneous improvements in microglial activation NEW YORK, Sept. 20, 2022 (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the second patient (\u201cEA2\u201d) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard clinical assessment. On September 12th, 2022, this patient had walked 100 &hellip; Continue reading &quot;Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2022-09-20T10:37:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODY0OTgyNCM1MTYxODc1IzIxMjM4ODU=\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab\",\"datePublished\":\"2022-09-20T10:37:26+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\\\/\"},\"wordCount\":682,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODY0OTgyNCM1MTYxODc1IzIxMjM4ODU=\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/tiziana-life-sciences-announces-continued-clinical-improvements-in-the-second-patient-with-secondary-progressive-multiple-sclerosis-spms-after-six-months-of-dosing-with-intranasal-foralumab\\\/\",\"name\":\"Tiziana Life Sciences Announces Continued Clinical Improvements in the Second Patient with Secondary Progressive Multiple Sclerosis (SPMS) After Six Months of Dosing with Intranasal Foralumab - 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The 6-month PET imaging will occur in Q4 2022 to confirm simultaneous improvements in microglial activation NEW YORK, Sept. 20, 2022 (GLOBE NEWSWIRE) &#8212; Tiziana Life Sciences Ltd. (Nasdaq: TLSA) (\u201cTiziana\u201d or the \u201cCompany\u201d), a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced that the second patient (\u201cEA2\u201d) with non-active secondary progressive multiple sclerosis (SPMS) receiving intranasal foralumab has shown additional clinical improvements as measured by the Expanded Disability Status Scale (EDSS), a standard clinical assessment. 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