SciSparc Announces Ethics Committee Approval to Conduct its Clinical Trial in Autism Spectrum Disorder
SciSparc Announces Ethics Committee Approval to Conduct its Clinical Trial in Autism Spectrum Disorder
SciSparc Ltd. (NASDAQ:SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, today announced that it has received approval from the Ethics Committee of The Soroka University Medical Center, in Be'er-Sheva, Israel (the "Ethics Committee"), to conduct the Company's clinical trial for SCI-210 in patients suffering from Autism Spectrum Disorder ("ASD").
專注於開發治療中樞神經系統疾病療法的專業臨牀階段製藥公司SciSparc Ltd.(納斯達克代碼：SPRC)(以下簡稱“公司”或“SciSparc”)今天宣佈，它已獲得位於以色列貝爾舍瓦的索羅卡大學醫學中心倫理委員會(以下簡稱“倫理委員會”)的批准，可以在自閉症譜系障礙患者中進行SCI-210的臨牀試驗。
The trial will investigate the effect of the Company's drug candidate SCI-210, a proprietary combination of cannabidiol ("CBD") and CannAmide™, versus CBD monotherapy, in treating ASD.
這項試驗將調查該公司的候選藥物SCI-210在治療自閉症方面的效果。SCI-210是大麻二酚(“CBD”)和坎納胺™的專利組合，與CBD單一療法相比。
The trial's objectives are to evaluate the safety, tolerability and efficacy of SCI-210 in children with ASD in a designed 20-week, randomized, double-blind, placebo controlled with a cross-over clinical trial of 60 children. The trial has three primary efficacy end points: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician; and the effective therapeutic dose.
這項試驗的目的是通過一項為期20周的設計、隨機、雙盲、安慰劑對照的交叉臨牀試驗，評估SCI-210在ASD兒童中的安全性、耐受性和有效性。這項試驗有三個主要的療效終點：異常行為檢查表-社區(ABC-C)父母問卷；臨牀醫生進行的臨牀總體印象-改善(CGI-I)；以及有效治療劑量。
"We are honored to receive the Ethics Committee approval, an important step toward initiation of our clinical trial in ASD," commented Oz Adler, SciSparc's Chief Executive Officer. We believe that our unique and proprietary SCI-210 has the potential to be a new treatment to reduce irritability and other symptoms associated with ASD in pediatric patients, a condition with limited available treatments. Just a month ago we announced the Ethics Committee approval of our novel and proprietary SCI-110 for the treatment of Tourette Syndrome and today with great enthusiasm we announce the Ethic Committee's approval of our novel and proprietary SCI-210 platform. These approvals are important milestones for SciSparc and they demonstrate our commitment to change the life of millions. Our drug candidates potentially enable us to provide effective and safer treatments with fewer side effects thanks to the lower doses of active ingredients, boosted by the combination with CannAmide™, a mission always desirable but even more so when children are the target population."
“我們很榮幸獲得倫理委員會的批准，這是朝着啟動我們的ASD臨牀試驗邁出的重要一步，”SciSparc首席執行官Oz Adler評論道。我們相信，我們獨特的專利SCI-210有可能成為一種新的治療方法，以減少兒科患者的過敏性和與ASD相關的其他症狀，ASD是一種可用治療有限的疾病。就在一個月前，我們宣佈倫理委員會批准了我們新穎專有的SCI-110用於治療抽動症，今天我們懷着極大的熱情宣佈倫理委員會批准我們新穎專有的SCI-210平臺。這些批准是本科學計劃的重要里程碑，它們表明了我們改變數百萬人生活的承諾。我們的候選藥物可能使我們能夠提供有效和更安全的治療方法，副作用更少，這要歸功於較低劑量的活性成分，再加上與™的結合，這是一項總是令人嚮往的任務，尤其是當兒童是目標人羣時更是如此。“
ASD is a condition related to brain development that impacts how a person perceives and socializes with others, causing problems in social interaction and communication. The term "spectrum" in autism spectrum disorder refers to the wide range of symptoms and severity.
自閉症是一種與大腦發育有關的疾病，影響一個人如何感知和與他人交往，導致社交和溝通方面的問題。自閉症譜系障礙中的“譜系”一詞指的是廣泛的症狀和嚴重程度。
The launch of the trial is pending further approvals by the Israeli Ministry of Health and the Israeli Medical Cannabis Agency.
該試驗的啟動尚待以色列衞生部和以色列醫用大麻機構的進一步批准。
譯文內容由第三人軟體翻譯。