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Phase 2 Psilocybin Therapy Trial For Patients With Treatment-Resistant PTSD: Latest Findings
Phase 2 Psilocybin Therapy Trial For Patients With Treatment-Resistant PTSD: Latest Findings
Cannabis company Creso Pharma (OTC:COPHF)'s wholly-owned psychedelics subsidiary Halucenex Life Sciences Inc. shared promising early findings on its ongoing Phase 2 clinical trial assessing the efficacy of psilocybin on treatment-resistant PTSD.
The single-arm, open-lab study tests the efficacy of Halucenex's synthetic psilocybin aqueous solution, Lucenex, in both 10mg and 25mg formats on severe PTSD symptoms of 20 patients.
The psychedelic is being administered in separate sessions in a microdose and macro dose format.
Severe PTSD symptoms measured are depression and anxiety. Other measures include sleep time, addiction severity, suicidal ideation, general psychological symptoms such as pain and interpersonal relationships, overall functioning, work capacity, and physiological measures such as weight and blood pressure.
Of the total participants, two patients to date have received both 10mg and 25mg subsequent doses, presenting no adverse effects and further highlighting particularly promising results: two doses of psilocybin, spread one week apart, lead to a marked decrease (40% after the first dose) in symptoms presented within severe, treatment-resistant PTSD.
Further, the second, macro-dose resulted in immediate decrease and full remission (av. 95%) in symptoms associated with PTSD: the patients presented zero symptoms of PTSD at one month post-macro dose, and a further 75% reduction of symptoms at three-months
Specifically, severe depression symptoms were abruptly discontinued after the macrodose, sustaining their remission into month three. Severe anxiety was reduced 50% immediately following macrodose in one case and 100% in the other, and month threes after still presented minimal, or remission scores.
Other outcomes include notable improvements in total sleep time, reduced cravings and need for THC during daytime and for sleep, significant improvements in blood pressure and social improvement with interpersonal relationships, all through the three months post-macrodose.
The outcomes have led Halucenex to apply for a Clinical Trial Amendment (CTA) with Health Canada to streamline the clinical trial process, de-risk attrition rates and mitigate scheduling stressors for participants.
The amendments were approved on April 26 and include a larger window for pre-screening, the ability of the company's CSO to prepare doses without the need for a compounding pharmacist, and the possibility to spread each patient's seventh visit over 1-3 days.
Pending the amendment's outcome, Halucenex still aims to administer the psychedelic to a weekly average of two patients and expects trial completion by the third quarter of 2023.
Photo: Benzinga edit with photo by YAKOBCHUK VIACHESLAV and Alexander_Volkov on Shutterstock.
Cannabis company Creso Pharma (OTC:COPHF)'s wholly-owned psychedelics subsidiary Halucenex Life Sciences Inc. shared promising early findings on its ongoing Phase 2 clinical trial assessing the efficacy of psilocybin on treatment-resistant PTSD.
大麻公司克雷索制药(场外交易代码:COPHF)的全资子公司迷幻药Halucenex生命科学公司分享了其正在进行的第二阶段临床试验中有希望的早期发现,该试验评估了裸盖菇素对耐药PTSD的疗效。
The single-arm, open-lab study tests the efficacy of Halucenex's synthetic psilocybin aqueous solution, Lucenex, in both 10mg and 25mg formats on severe PTSD symptoms of 20 patients.
这项单臂开放实验室研究测试了Halucenex合成裸盖菇素水溶液Lucenex 10 mg和25 mg两种形式对20名患者严重PTSD症状的疗效。
The psychedelic is being administered in separate sessions in a microdose and macro dose format.
迷幻剂以微剂量和大剂量的形式在单独的疗程中给药。
Severe PTSD symptoms measured are depression and anxiety. Other measures include sleep time, addiction severity, suicidal ideation, general psychological symptoms such as pain and interpersonal relationships, overall functioning, work capacity, and physiological measures such as weight and blood pressure.
严重的创伤后应激障碍症状包括抑郁和焦虑。其他衡量标准包括睡眠时间、成瘾严重程度、自杀意念、疼痛和人际关系等一般心理症状、整体功能、工作能力以及体重和血压等生理指标。
Of the total participants, two patients to date have received both 10mg and 25mg subsequent doses, presenting no adverse effects and further highlighting particularly promising results: two doses of psilocybin, spread one week apart, lead to a marked decrease (40% after the first dose) in symptoms presented within severe, treatment-resistant PTSD.
在所有参与者中,到目前为止,有两名患者接受了10 mg和25 mg的后续剂量,没有出现不良反应,进一步突出了特别有希望的结果:两次剂量的裸盖菇素,间隔一周,导致严重的、耐药的PTSD的症状显著减少(第一次剂量后40%)。
Further, the second, macro-dose resulted in immediate decrease and full remission (av. 95%) in symptoms associated with PTSD: the patients presented zero symptoms of PTSD at one month post-macro dose, and a further 75% reduction of symptoms at three-months
此外,第二次大剂量治疗导致立即减少和完全缓解(av.95%)与创伤后应激障碍相关的症状:患者在服用宏观剂量后一个月没有出现创伤后应激障碍症状,三个月后症状进一步减轻75%
Specifically, severe depression symptoms were abruptly discontinued after the macrodose, sustaining their remission into month three. Severe anxiety was reduced 50% immediately following macrodose in one case and 100% in the other, and month threes after still presented minimal, or remission scores.
具体地说,严重的抑郁症状在大剂量后突然停止,持续缓解到第三个月。严重焦虑在大剂量后立即减少了50%,在另一个病例中是100%,三个月后仍然表现出最低或缓解评分。
Other outcomes include notable improvements in total sleep time, reduced cravings and need for THC during daytime and for sleep, significant improvements in blood pressure and social improvement with interpersonal relationships, all through the three months post-macrodose.
其他结果包括总睡眠时间显著改善,白天和睡眠时对THC的渴望和需求减少,血压显著改善,人际关系改善,所有这些都是在大剂量服药后的三个月内完成的。
The outcomes have led Halucenex to apply for a Clinical Trial Amendment (CTA) with Health Canada to streamline the clinical trial process, de-risk attrition rates and mitigate scheduling stressors for participants.
结果导致Halucenex与加拿大卫生部申请了临床试验修正案(CTA),以简化临床试验流程,降低风险流失率,并缓解参与者的日程安排压力。
The amendments were approved on April 26 and include a larger window for pre-screening, the ability of the company's CSO to prepare doses without the need for a compounding pharmacist, and the possibility to spread each patient's seventh visit over 1-3 days.
修正案于4月26日获得批准,包括更大的预筛查窗口,该公司的CSO能够在不需要复合药剂师的情况下准备剂量,以及可能将每个患者的第七次就诊时间分散在1-3天内。
Pending the amendment's outcome, Halucenex still aims to administer the psychedelic to a weekly average of two patients and expects trial completion by the third quarter of 2023.
在修正案公布结果之前,Halucenex的目标仍然是每周平均给两名患者服用迷幻剂,预计试验将于2023年第三季度完成。
Photo: Benzinga edit with photo by YAKOBCHUK VIACHESLAV and Alexander_Volkov on Shutterstock.
图片:Benzinga编辑与YAKOBCHUK Viacheslav和Alexander_Volkov在Shutterstock上的照片。
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在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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moomoo是Moomoo Technologies Inc.公司提供的金融信息和交易应用程序。
在美国,moomoo上的投资产品和服务由Moomoo Financial Inc.提供,一家受美国证券交易委员会(SEC)监管的持牌主体。 Moomoo Financial Inc.是金融业监管局(FINRA)和证券投资者保护公司(SIPC)的成员。
在新加坡,moomoo上的投资产品和服务是通过Moomoo Financial Singapore Pte. Ltd.提供,该公司受新加坡金融管理局(MAS)监管(牌照号码︰CMS101000) ,持有资本市场服务牌照 (CMS) ,持有财务顾问豁免(Exempt Financial Adviser)资质。本内容未经新加坡金融管理局的审查。
在澳大利亚,moomoo上的金融产品和服务是通过Futu Securities (Australia) Ltd提供,该公司是受澳大利亚证券和投资委员会(ASIC)监管的澳大利亚金融服务许可机构(AFSL No. 224663)。请阅读并理解我们的《金融服务指南》、《条款与条件》、《隐私政策》和其他披露文件,这些文件可在我们的网站 https://www.moomoo.com/au中获取。
在加拿大,通过moomoo应用提供的仅限订单执行的券商服务由Moomoo Financial Canada Inc.提供,并受加拿大投资监管机构(CIRO)监管。
在马来西亚,moomoo上的投资产品和服务是通过Moomoo Securities Malaysia Sdn. Bhd. 提供,该公司受马来西亚证券监督委员会(SC)监管(牌照号码︰eCMSL/A0397/2024) ,持有资本市场服务牌照 (CMSL) 。本内容未经马来西亚证券监督委员会的审查。
Moomoo Technologies Inc., Moomoo Financial Inc., Moomoo Financial Singapore Pte. Ltd., Futu Securities (Australia) Ltd, Moomoo Financial Canada Inc.,和Moomoo Securities Malaysia Sdn. Bhd.是关联公司。
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