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
歐洲垂直整合的大麻藥物製造商AvExtra AG推出AvExtra循證大麻醫學聯盟星期三。
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.
該聯盟是一項推動研究和大麻素類藥物的研究進展這家總部位於德國的公司表示，在歐洲市場，聯盟監管的患者準入計劃已經到位。
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.
在這些市場，AvExtra正在努力與一個強大的早期採用研究人員和從業者網路建立關係，以告知和豐富其藥物開發的臨床計劃。
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的聯盟將結合真實世界證據研究和隨機對照試驗，在具有重大未滿足患者臨床需求的靶向適應症中採用不同的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.
為什麼？其目標是增加證據，以支持使用AvExtra的高級產品進行治療，並在進行確定療效、安全性和患者利益的隨機對照試驗後獲得全面的監管批准和報銷。
See also: Children's Palliative Care & Medical Cannabis: Australian Researchers Conduct Pilot Study
另見：兒童姑息治療和醫用大麻：澳大利亞研究人員進行初步研究
BELCANTO Study To Examine Medical Cannabis Treatment For Early-Stage Palliative Care Patients
Belcanto研究檢查早期姑息治療患者的醫用大麻療法
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.
為了標誌著它的開始，該聯盟宣佈支持其第一項第二階段研究-一項名為Belcanto的隨機、雙盲、安慰劑對照臨床試驗，該試驗於2023年夏天獲得聯盟藥物和醫療設備研究所(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.
這項研究的重點是使用AvExtra自己的平衡10THC/10CBD標準化大麻提取物治療早期姑息治療腫瘤學患者，目前在德國、義大利、瑞士和英國市場上可以買到。
Avextra's CEO Dr. Bernhard Babel praised the move.
AvExtra首席執行官伯恩哈德·巴貝爾博士他稱讚了這一舉動。
"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."
“貝爾坎託是啟動AvExtra的循證大麻醫學聯盟的理想專案，”巴貝爾博士說。與所有藥物一樣，一旦監管機構在強有力的臨床試驗的基礎上批准了藥用大麻的有效性和安全性，藥用大麻治療將成為姑息治療患者的一種引人注目的治療選擇。
The trial will be mainly conducted at University Clinics in Kiel and clinical centers in Hamburg and Lübeck, enrolling approximately 170 cancer patients.
這項試驗將主要在基爾的大學診所以及漢堡和LüBeck的臨床中心進行，招募約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.
研究人員計劃將接受平衡大麻提取物治療的腫瘤患者的總體癥狀負擔的變化與安慰劑對照組進行比較。
Now read: Medical Marijuana In Hospice: How Cannabis Can Help With End-Of-Life Care
現在閱讀：臨終關懷中的醫用大麻：大麻如何幫助臨終關懷
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Photo: Courtesy of Dominik Lange on Unsplash
圖片：Unspash上由Dominik Lange提供
譯文內容由第三人軟體翻譯。