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
在针对儿科患者自闭症谱系障碍的随机、对照、双盲临床试验中，已为第一位患者服药
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.
以色列特拉维夫，2024年3月14日（GLOBE NEWSWIRE）——专注于开发治疗中枢神经系统疾病和罕见疾病疗法的专业临床阶段制药公司ScisPARC Ltd.（纳斯达克股票代码：SPRC）（“公司” 或 “ScisPARC”）今天宣布，它已在索罗卡医学中心为自闭症谱系障碍儿科患者进行的 SCI-210 临床试验中成功给首位患者给药（“ASD”）。这一重要里程碑是在该公司最近宣布成功向临床试验场所交付其创新的 SCI-210 疗法之后发生的，从而得以开始给药。
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 专有的 SCI-210 疗法结合了富含大麻二酚的油（“CBD”）和 ScisPARC 专有的基于棕榈酰乙醇酰胺的片剂 CannaMide。在寻求为自闭症提供更有效和更安全的治疗选择的过程中，第一位患者的剂量标志着从预备阶段过渡到积极的治疗评估。
"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."
“在任何临床试验中，给第一位患者给药始终是一个激动人心的时刻。ScisPARC首席执行官奥兹·阿德勒说，在我们努力为与这种疾病作斗争的患者、家庭成员和看护人提供新的希望之际，我们很高兴能启动 SCI-210 的下一阶段开发。“我们很高兴达到这个里程碑，这使我们离可能为受自闭症障碍影响的患者和家庭提供新的希望灯塔又近了一步。我们感谢参与临床试验的患者、梅里教授及其团队。这一成就对ScisPARC来说是一个关键时刻，因为我们推出了一种基于大麻素的创新疗法 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.
该临床试验旨在严格评估 SCI-210 与 CBD 单一疗法治疗自闭症障碍的安全性、耐受性和疗效。该研究设计为一项交叉的随机、双盲、安慰剂对照的临床试验，将持续20周，招收60名儿童。该试验的主要疗效终点包括三项严格的评估：异常行为清单社区（ABC-C）家长问卷；由医疗保健专业人员管理的临床全球印象改善（CGI-I）量表；以及有效治疗剂量的确定。