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PharmaTher Presents Positive Data On Ketamine For Treatment Of Dyskinesia In Parkinson's Disease
PharmaTher Presents Positive Data On Ketamine For Treatment Of Dyskinesia In Parkinson's Disease
PharmaTher Holdings Ltd. (OTCQB:PHRRF) (CSE:PHRM), a leader in specialty ketamine pharmaceuticals, announced Friday that the Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson's disease was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders in Madrid, Spain, reported Psychedelic Finance.
"We are pleased to see the first presentation of the data from the Phase 1/2 study of ketamine demonstrating ketamine's safety and tolerability with clinically meaningful efficacy that supports further investigation in a proposed Phase 3 clinical study as a potential new treatment for levodopa-induced dyskinesia in Parkinson's disease patients," said Fabio Chianelli, CEO of PharmaTher.
"With these data and the recent US Notice of Allowance of the patent application for ketamine in the potential treatment of Parkinson's Disease and motor disorders, we are now focused on obtaining an agreement with the FDA to pursue approval under 505(b)(2) regulatory pathway with a potential Phase 3 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease," added the CEO.
Highlights Of The Study
- Ketamine was safe and well-tolerated with 100% of patients treated with ketamine demonstrating a reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale (UDysRS).
- UDysRS showed a 51% reduction from baseline during Infusion 2 (p=0.003), 49% at 3-week (p=0.006) and 41% at 3-month (p=0.011) post-ketamine.
- Planning a Phase 3 clinical study to allow for FDA approval of KETARX (ketamine) for Parkinson's disease under the 505(b)(2) regulatory pathway
"The Phase 1/2 study was an open-label, dose-finding trial to test the safety, tolerability, and pharmacokinetics of low-dose ketamine infusion to treat levodopa-induced dyskinesia ("LID") in Parkinson's disease and to find an effective dose-range suitable for outpatient use. The clinical study outcomes measured reduction of dyskinesia, captured with the Unified Dyskinesia Rating Scale ("UDysRS"), and effects on parkinsonian symptoms, captured with the Unified Parkinson's Disease Rating Scale ("UPDRS")," reported PharmaTer in a press release.
"The study enrolled 10 subjects with moderate to advanced Parkinson's disease with a target infusion rate being 0.30 mg/kg/hr. These data highlight that ketamine was safe, well-tolerated, and demonstrated that 100% of subjects treated with ketamine had a reduction in dyskinesias as measured by UDysRS indicating possible efficacy with a large effect size that warrants further investigation in a pivotal Phase 3 clinical study. UDysRS showed a clinically meaningful reduction from baseline through 3 months," per the release.
Ketamine's Potential In Parkinson's Disease
Parkinson's disease is a debilitating disorder whose market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025. "It is estimated that the potential market opportunity for LID Parkinson's disease to be over USD $3 billion in the U.S. alone. Ketamine is an FDA-approved substance that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents," added the firm.
Photo by Louis Reed on Unsplash.
PharmaTher Holdings Ltd. (OTCQB:PHRRF) (CSE:PHRM), a leader in specialty ketamine pharmaceuticals, announced Friday that the Phase 1/2 clinical study of ketamine in the treatment of levodopa-induced dyskinesia in Parkinson's disease was presented at the MDS International Congress of Parkinson's Disease and Movement Disorders in Madrid, Spain, reported Psychedelic Finance.
PharmaTher Holdings Ltd.(OTCQB:PHRRF)(CSE:PHRM)是专业氯胺酮药物的领先者,该公司周五宣布,氯胺酮治疗高血压的1/2期临床研究帕金森病患者左旋多巴诱发的运动障碍在大会上发表MDS 帕金森氏病和运动障碍国际会议在西班牙马德里,《迷幻金融》报道称。
"We are pleased to see the first presentation of the data from the Phase 1/2 study of ketamine demonstrating ketamine's safety and tolerability with clinically meaningful efficacy that supports further investigation in a proposed Phase 3 clinical study as a potential new treatment for levodopa-induced dyskinesia in Parkinson's disease patients," said Fabio Chianelli, CEO of PharmaTher.
他说:“我们很高兴看到氯胺酮1/2期研究的数据首次公布,证明了氯胺酮的安全性和耐受性,具有临床意义,这支持在拟议的3期临床研究中进一步研究,作为治疗帕金森病患者左旋多巴引起的运动障碍的潜在新疗法。”法比奥·奇亚内利PharmaTher的首席执行官。
"With these data and the recent US Notice of Allowance of the patent application for ketamine in the potential treatment of Parkinson's Disease and motor disorders, we are now focused on obtaining an agreement with the FDA to pursue approval under 505(b)(2) regulatory pathway with a potential Phase 3 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson's disease," added the CEO.
这位首席执行官补充说:“有了这些数据,以及最近美国关于氯胺酮可能治疗帕金森氏病和运动障碍的专利申请许可的通知,我们现在正专注于与FDA达成协议,根据505(B)(2)调控路径寻求批准,并可能进行氯胺酮治疗帕金森病患者左旋多巴诱发的运动障碍的第三阶段临床研究。”
Highlights Of The Study
研究的要点
- Ketamine was safe and well-tolerated with 100% of patients treated with ketamine demonstrating a reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale (UDysRS).
- UDysRS showed a 51% reduction from baseline during Infusion 2 (p=0.003), 49% at 3-week (p=0.006) and 41% at 3-month (p=0.011) post-ketamine.
- Planning a Phase 3 clinical study to allow for FDA approval of KETARX (ketamine) for Parkinson's disease under the 505(b)(2) regulatory pathway
- 氯胺酮是安全的,耐受性良好,100%的患者使用氯胺酮治疗后,根据统一运动障碍评定量表(UDysRS)衡量,运动障碍有所减少。
- UDysRS在输注2周(p=0.003)、3周(p=0.006)和3个月(p=0.011)时较基线分别减少51%、49%(p=0.006)和41%。
- 计划3期临床研究,以允许FDA批准凯塔克斯505(B)(2)调控通路下的氯胺酮治疗帕金森病
"The Phase 1/2 study was an open-label, dose-finding trial to test the safety, tolerability, and pharmacokinetics of low-dose ketamine infusion to treat levodopa-induced dyskinesia ("LID") in Parkinson's disease and to find an effective dose-range suitable for outpatient use. The clinical study outcomes measured reduction of dyskinesia, captured with the Unified Dyskinesia Rating Scale ("UDysRS"), and effects on parkinsonian symptoms, captured with the Unified Parkinson's Disease Rating Scale ("UPDRS")," reported PharmaTer in a press release.
PharmaTer在一份新闻稿中说:“1/2期研究是一项开放标签的剂量发现试验,目的是测试小剂量氯胺酮输注治疗帕金森病左旋多巴诱发的运动障碍(LID)的安全性、耐受性和药代动力学,并找到适合门诊使用的有效剂量范围。临床研究结果通过统一的运动障碍评定量表(UDysRS)测量运动障碍的减少,并通过统一帕金森病评定量表(UPDRS)测量对帕金森症状的影响。
"The study enrolled 10 subjects with moderate to advanced Parkinson's disease with a target infusion rate being 0.30 mg/kg/hr. These data highlight that ketamine was safe, well-tolerated, and demonstrated that 100% of subjects treated with ketamine had a reduction in dyskinesias as measured by UDysRS indicating possible efficacy with a large effect size that warrants further investigation in a pivotal Phase 3 clinical study. UDysRS showed a clinically meaningful reduction from baseline through 3 months," per the release.
这项研究招募了10名中晚期帕金森氏症患者,目标输注速度为0.30毫克/公斤/小时。这些数据突出表明,氯胺酮是安全的,耐受性良好,并表明100%使用氯胺酮的受试者在UDysRS测量中减少了运动障碍,这表明可能有效,值得在关键的3期临床研究中进一步研究。UDysRS显示,从基线到3个月的临床有意义的减少。
Ketamine's Potential In Parkinson's Disease
氯胺酮在帕金森病中的潜在作用
Parkinson's disease is a debilitating disorder whose market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025. "It is estimated that the potential market opportunity for LID Parkinson's disease to be over USD $3 billion in the U.S. alone. Ketamine is an FDA-approved substance that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents," added the firm.
帕金森氏症是一种令人衰弱的疾病,其市场预计将从2019年的50亿美元增长到2025年底的75亿美元。据估计,仅在美国,LID帕金森氏症的潜在市场机会就超过30亿美元。氯胺酮是FDA批准的一种物质,被广泛用作麻醉剂,无论是单独使用还是与其他麻醉剂联合使用。
Photo by Louis Reed on Unsplash.
路易·里德在Unspash上拍摄的照片。
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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。
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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。
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