MediciNova Announces That The National Institutes Of Health Neurological Disorders And Stroke Has Awarded $22M For An Intermediate Size Expanded Access Protocol To Evaluate The Efficacy Of MN-166 In Amyotrophic Lateral Sclerosis
MediciNova Announces That The National Institutes Of Health Neurological Disorders And Stroke Has Awarded $22M For An Intermediate Size Expanded Access Protocol To Evaluate The Efficacy Of MN-166 In Amyotrophic Lateral Sclerosis
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the National Institutes of Health (NIH) - Neurological Disorders and Stroke (NINDS) has awarded $22 million for an intermediate size Expanded Access Protocol (EAP) to evaluate the efficacy of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS)1,2. In collaboration with an academic group, MediciNova will provide investigational drug MN-166 (ibudilast), regulatory support, and safety monitoring support.
美第奇新星生物技術公司，一家在納斯達克全球股市（NASDAQ：MNOV）和東京證券交易所標準市場（代碼編號：4875）上市的生物製藥公司，今日宣佈，美國國立衛生研究院（NIH）-神經疾病與中風（NINDS）已授予2200萬美元用於評估MN-166（伊布地拉斯特）在肌萎縮側索硬化症（ALS）中的療效中等規模擴大適應性計劃（EAP）。與學術團體合作，美第奇新星將提供MN-166（伊布地拉斯特）作爲研究用藥，監管支持和安全監測支持。
The NIH grant is supported by the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) signed into law by President Biden. Expanded Access, also referred to as Compassionate Use, is an FDA-regulated pathway that allows individuals with a serious and life-threatening disease to access an investigational drug that is not yet approved by the FDA. This EAP trial will allow individuals with ALS who are not eligible to participate in the COMBAT-ALS trial to receive treatment with MN-166. The EAP will evaluate neurofilament light, a biomarker for neuron damage, and clinical data in two hundred (200) ALS patients treated with MN-166.
NIH撥款得到了拜登總統簽署的《加速獲得ALS關鍵治療的法案》（ACt for ALS）的支持。擴大適應性，也稱爲臨床治療使用，是FDA監管的一種途徑，允許患有嚴重和危及生命的疾病的個體使用尚未獲得FDA批准的研究用藥。此次EAP試驗將允許不能參與COMBAt-ALS試驗的ALS患者接受MN-166治療。EAP將評估兩百（200）名接受MN-166治療的ALS患者的神經絲輕鏈，即神經元損傷的生物標誌物，以及臨床數據。
譯文內容由第三人軟體翻譯。