Medical Cannabis For Cancer Patients' Palliative Care Is Focus Of New European Research Project
Medical Cannabis For Cancer Patients' Palliative Care Is Focus Of New European Research Project
European vertically-integrated manufacturer of cannabis-based medicines Avextra AG unveiled the Avextra Alliance for Evidence-based Cannabis Medicine on Wednesday
欧洲垂直整合的大麻药物制造商AvExtra AG推出AvExtra循证大麻医学联盟星期三。
The alliance is an initiative to advance research and development in cannabinoid-based therapies in European markets where federally regulated patient access schemes are in place, the German-based company said.
该联盟是一项推动研究和大麻素类药物的研究进展这家总部位于德国的公司表示,在欧洲市场,联邦监管的患者准入计划已经到位。
In these markets, Avextra is working on creating relationships with a strong network of early-adopting researchers and practitioners to inform and enrich its clinical plan for pharmaceutical development.
在这些市场,AvExtra正在努力与一个强大的早期采用研究人员和从业者网络建立关系,以告知和丰富其药物开发的临床计划。
Avextra's alliance will combine Real-World Evidence studies and randomized controlled trials with different galenic forms in targeted indications with significant unmet patient clinical needs.
AvExtra的联盟将结合真实世界证据研究和随机对照试验,在具有重大未满足患者临床需求的靶向适应症中采用不同的Galen形式。
Why? The goal is to increase the evidence to support therapy with Avextra's magistral products and to obtain full regulatory approval and reimbursement after conducting RCTs that determine efficacy, safety and patient benefit.
为什么?其目标是增加证据,以支持使用AvExtra的高级产品进行治疗,并在进行确定疗效、安全性和患者利益的随机对照试验后获得全面的监管批准和报销。
See also: Children's Palliative Care & Medical Cannabis: Australian Researchers Conduct Pilot Study
另见:儿童姑息治疗和医用大麻:澳大利亚研究人员进行初步研究
BELCANTO Study To Examine Medical Cannabis Treatment For Early-Stage Palliative Care Patients
Belcanto研究检查早期姑息治疗患者的医用大麻疗法
To mark its start, the alliance announced support of its first Phase 2 study – a randomized, double-blind, placebo-controlled clinical trial under the name BELCANTO, which was approved by the Federal Institute for Drugs and Medical Devices (BfArM) over the summer of 2023.
为了标志着它的开始,该联盟宣布支持其第一项第二阶段研究-一项名为Belcanto的随机、双盲、安慰剂对照临床试验,该试验于2023年夏天获得联邦药物和医疗设备研究所(BfArM)的批准。
The study is focused on treating early palliative care oncology patients with Avextra's own balanced 10 THC/10 CBD standardized cannabis extract currently available on the German, Italian, Switzerland and UK markets.
这项研究的重点是使用AvExtra自己的平衡10THC/10CBD标准化大麻提取物治疗早期姑息治疗肿瘤学患者,目前在德国、意大利、瑞士和英国市场上可以买到。
Avextra's CEO Dr. Bernhard Babel praised the move.
AvExtra首席执行官伯恩哈德·巴贝尔博士他称赞了这一举动。
"BELCANTO is an ideal project to launch Avextra's Alliance for Evidence-based Cannabis Medicine," Dr. Babel said. "As in the case of all pharmaceutical drugs, medicinal cannabis treatments will become a compelling therapeutic option for patients in palliative care once regulatory agencies have approved its efficacy and safety on the basis of robust clinical trials."
“贝尔坎托是启动AvExtra的循证大麻医学联盟的理想项目,”巴贝尔博士说。与所有药物一样,一旦监管机构在强有力的临床试验的基础上批准了药用大麻的有效性和安全性,药用大麻治疗将成为姑息治疗患者的一种引人注目的治疗选择。
The trial will be mainly conducted at University Clinics in Kiel and clinical centers in Hamburg and Lübeck, enrolling approximately 170 cancer patients.
这项试验将主要在基尔的大学诊所以及汉堡和LüBeck的临床中心进行,招募约170名癌症患者。
Researchers plan to compare the change in overall symptom burden in oncology patients treated with a balanced cannabis extract with the placebo control group.
研究人员计划将接受平衡大麻提取物治疗的肿瘤患者的总体症状负担的变化与安慰剂对照组进行比较。
Now read: Medical Marijuana In Hospice: How Cannabis Can Help With End-Of-Life Care
现在阅读:临终关怀中的医用大麻:大麻如何帮助临终关怀
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Photo: Courtesy of Dominik Lange on Unsplash
图片:Unspash上由Dominik Lange提供