SciSparc Achieves Major Milestone With First Patient Dosed in Autism Spectrum Disorder Clinical Trial
SciSparc Achieves Major Milestone With First Patient Dosed in Autism Spectrum Disorder Clinical Trial
First patient has been dosed in the randomized, controlled, double blind clinical trial for Autism Spectrum Disorder in pediatric patients
在針對兒科患者自閉症譜系障礙的隨機、對照、雙盲臨床試驗中，已爲第一位患者服藥
TEL AVIV, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that it has successfully dosed the first patient in its SCI-210 clinical trial at the Soroka Medical Center for pediatric patients who have Autism Spectrum Disorder ("ASD"). This significant milestone follows the Company's recent announcement about the successful delivery of its innovative SCI-210 treatment to the clinical trial site, enabling the commencement of dosing.
以色列特拉維夫，2024年3月14日（GLOBE NEWSWIRE）——專注於開發治療中樞神經系統疾病和罕見疾病療法的專業臨床階段製藥公司ScisPARC Ltd.（納斯達克股票代碼：SPRC）（“公司” 或 “ScisPARC”）今天宣佈，它已在索羅卡醫學中心爲自閉症譜系障礙兒科患者進行的 SCI-210 臨床試驗中成功給首位患者給藥（“ASD”）。這一重要里程碑是在該公司最近宣佈成功向臨床試驗場所交付其創新的 SCI-210 療法之後發生的，從而得以開始給藥。
SciSparc's proprietary SCI-210 treatment combines cannabidiol-rich oil ("CBD") and CannAmide, SciSparc's proprietary palmitoylethanolamide-based tablets. The dosing of the first patient signifies the transition from preparatory phases to active treatment evaluation in the quest to offer a more effective and safe treatment option for ASD.
ScisPARC 專有的 SCI-210 療法結合了富含大麻二酚的油（“CBD”）和 ScisPARC 專有的基於棕櫚酰乙醇酰胺的片劑 CannaMide。在尋求爲自閉症提供更有效和更安全的治療選擇的過程中，第一位患者的劑量標誌着從預備階段過渡到積極的治療評估。
"Dosing the first patient is always an exciting moment in any clinical trial. As we work to offer new hope to the patients, family members, and caretakers who are battling this disorder, we are excited to kick-off this next phase of development for SCI-210," said Oz Adler, SciSparc's Chief Executive Officer. "We are thrilled to reach this milestone, which brings us one step closer to potentially offering a new beacon of hope for patients and families affected by ASD. We are grateful to the patients, Professor Meiri and his team involved in the clinical trial. This achievement represents a pivotal moment for SciSparc as we introduce SCI-210, an innovative cannabinoid-based treatment."
“在任何臨床試驗中，給第一位患者給藥始終是一個激動人心的時刻。ScisPARC首席執行官奧茲·阿德勒說，在我們努力爲與這種疾病作鬥爭的患者、家庭成員和看護人提供新的希望之際，我們很高興能啓動 SCI-210 的下一階段開發。“我們很高興達到這個里程碑，這使我們離可能爲受自閉症障礙影響的患者和家庭提供新的希望燈塔又近了一步。我們感謝參與臨床試驗的患者、梅里教授及其團隊。這一成就對ScisPARC來說是一個關鍵時刻，因爲我們推出了一種基於大麻素的創新療法 SCI-210。”
The clinical trial aims to rigorously evaluate the safety, tolerability, and efficacy of SCI-210 in comparison to CBD monotherapy for the treatment of ASD. Designed as a randomized, double-blind, placebo-controlled clinical trial with cross-over, the study will span 20 weeks and enroll 60 children. The trial's primary efficacy endpoints include three rigorous assessments: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) scale administered by healthcare professionals; and the determination of the effective therapeutic dosage.
該臨床試驗旨在嚴格評估 SCI-210 與 CBD 單一療法治療自閉症障礙的安全性、耐受性和療效。該研究設計爲一項交叉的隨機、雙盲、安慰劑對照的臨床試驗，將持續20周，招收60名兒童。該試驗的主要療效終點包括三項嚴格的評估：異常行爲清單社區（ABC-C）家長問卷；由醫療保健專業人員管理的臨床全球印象改善（CGI-I）量表；以及有效治療劑量的確定。
譯文內容由第三人軟體翻譯。